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Impact of single-port cholecystectomy on postoperative pain

Impact of single-port cholecystectomy on postoperative pain Abstract Background This study compared postoperative pain following four-port laparoscopic cholecystectomy (LC) and single-port cholecystectomy (SPC). Method This prospective, quasi-randomized, single-centre trial focusing on postoperative pain included 49 patients undergoing elective surgery with either a conventional LC, or SPC using a surgical glove port. Postoperative pain was evaluated using a visual analogue scale (VAS) and postoperative analgesic use as primary outcome measures. Total duration of operation, length of hospital stay, blood test results on the day after surgery and total port cost were secondary outcome measures. Results Twenty-five LCs and 24 SPCs were undertaken. The VAS score on day 1 after surgery was significantly less in the SPC group than in the LC group: median (range) 24 (12–38) versus 45 (33–57) mm (P = 0·002). Significantly fewer patients in the SPC group required analgesia (9 of 24 versus 19 of 25 in the LC group; P = 0·007). There were no significant differences in total duration of operation, length of hospital stay, and blood test results on the day after surgery. Conclusion Single-port surgery using a surgical glove port reduces postoperative pain compared with conventional LC. Registration number: UMIN000002539 (http://www.umin.ac.jp/ctr/index.htm). Introduction Single-port surgery was first reported in 19941–3. However, the timing seemed premature for surgeons and society, and the concept faded. In the 21st century, a new idea, natural orifice transluminal endoscopic surgery (NOTES), was introduced, providing a good opportunity for surgeons to rethink minimally invasive procedures4–6. Now, attention is again being focused on single-port surgery, whereas the adoption of NOTES has slowed owing to difficulties with the development of new devices, as well as ethical and economic concerns. A preliminary series of single-port cholecystectomy (SPC) and clinical use of single-port procedures have been reported7,8. However, the superiority of SPC over conventional laparoscopic cholecystectomy (LC) is not yet evident. Surgeons may be sceptical about SPC because of concerns about high cost and patient safety. In addition, as conventional three- or four-port cholecystectomy is well established, it is difficult for the general surgeon to imagine an even less invasive surgical approach. A smaller incision is undoubtedly less invasive; this has already been proven by the paradigm shift from open to laparoscopic surgery. However, the effects of small-incision SPC compared with conventional cholecystectomy have not yet been fully investigated. The present study was undertaken to assess the effectiveness of SPC using a surgical glove port compared with conventional LC in terms of postoperative pain. Methods All patients scheduled to undergo cholecystectomy for clinically benign gallbladder disease at this institution were enrolled in the trial between June 2009 and December 2009. Men and women aged 20–85 years who provided written informed consent were included. Patients with common bile duct stones diagnosed before or during surgery, those who had undergone upper abdominal surgery previously, and emergency presentations were excluded from the study. The study protocol was approved by the institutional review board. An English-language summary of the protocol was submitted to the Clinical Trials Registry managed by the University Hospital Medical Information Network in Japan (registration number UMIN000002539; http://www.umin.ac.jp/ctr/index.htm). Quasi-randomization and endpoints Allocation to SPC or LC was based solely on day of the week; SPCs were performed on Fridays and LCs on the other days. No factor that could affect surgical difficulty, such as disease, body mass index (BMI) and inflammation, was considered in the choice of procedure. There was no attempt to randomize patients blindly, and patient requests for a particular procedure (either SPC or conventional LC) were honoured. The primary endpoint was postoperative pain evaluated by visual analogue scale (VAS) scores and postoperative analgesic use. Before surgery, all patients were taught how to score pain on the VAS (0 mm, no pain; 100 mm, maximal pain)9, and they were clearly told that they would not be given analgesics during the postoperative period unless they asked for them. All VAS scoring was done by the attending nurse at 09.00 hours on the day after surgery. Secondary outcome measures were the total duration of operation, length of hospital stay, and blood test results on the day after operation. Operative technique All operations were performed by two surgeons. Each had performed more than 50 conventional LCs and had no experience with SPC before starting this trial. For both SPC and LC, all patients were fasted from the morning of the day of operation. Operations were done under general anaesthesia without epidural anaesthesia. An ultrasonic dissector was not used in either group. In all patients, the abdominal space was lavaged with 1000 ml saline at the end of the procedure; no local anaesthesia was applied to the wound and no drain was placed. Intraoperative cholangiography was performed in all patients except those scheduled for cholecystectomy because of gallbladder polyps and those who had undergone preoperative endoscopic retrograde cholangiopancreatography. Laparoscopic cholecystectomy LC was done using four trocars, with the patient in the reverse Trendelenburg position and the surgeon positioned to the left of the patient. First, a vertical 1·5-cm incision was made in the middle of the umbilicus and a 12-mm trocar inserted, after which pneumoperitoneum was created. Another 5-mm trocar was placed in the mid-epigastrium, and two 5-mm trocars were placed in the right upper abdomen, two fingerbreadths below the right costal margin in the mid-clavicular and mid-axillary lines. Single-port cholecystectomy A single surgeon performed all SPCs. The patient was placed in the French position with the surgeon between the legs, and the first assistant controlled the optics on the left side of the patient. A surgical glove port was used as reported previously10. In brief, the operation started with a skin incision at the umbilicus, exactly 1·5 cm long for patients with a BMI of less than 25 kg/m2 and 2·0 cm long for those with a higher BMI (Video S1, supporting information). Subcutaneous dissection was not performed in any patient. A 2/0 bladed absorbable thread was placed on the fascia for later closure to prevent umbilical hernia. Subsequently, an Alexis® wound retractor (XS size; Applied Medical, Rancho Santa Margarita, California, USA) was installed in the umbilical wound and used to dilate the wound, creating a single free oval hole approximately 2·5 × 2·0 cm in diameter. A non-powdered surgical glove was attached to the wound retractor, and was shown to be airtight. The tips of the glove's thumb, middle and small fingers were cut, and a 5-mm slim trocar (LiNA Medical, Glostrup, Denmark) was inserted into each (Fig. 1a). The assistant inserted a semiflexible laparoscopic camera (LTFVH; Olympus, Tokyo, Japan) via the middle-finger 5-mm port. The abdominal cavity was checked, and a 2/0 nylon thread with a straight needle then placed from the epigastric area to elevate the falciform ligament. This technique allowed the operator to obtain good working space around Calot's triangle. Cholecystectomy was performed using a grasper in the left hand and an Opti 4™ (Covidien, Norwalk, Connecticut, USA) in the right hand (Fig. 1b). This device has multiple functions in one instrument, such as suction, irrigation and a dissection hook. Intraoperative cholangiography was performed via the surgical glove port without adding any other port or puncture. Fig. 1 Open in new tabDownload slide a Set-up of the surgical glove port; three slim ports were inserted via the finger tips. Pneumoperitoneum was controlled by a carbon dioxide insufflator connected to a small finger. b Operative view; separation of the trocars allowed full movement of instruments Statistical analysis The study started without a formal sample size calculation because of lack of data. For the first five patients in each group in this study, the mean VAS score was 25 for the SPC group and 40 for the LC group (median 22 and 38 respectively). This suggested that SPC may decrease postoperative pain by 37 per cent. The sample size required was 22 patients in each group (total 44) to detect a significant difference using a two-tailed test with a type I error of 5 per cent and statistical power of 80 per cent. Allowing for a 5 per cent dropout rate, the total number of patients to be included was set at 46. All data were analysed on an intention-to-treat basis, and postoperative pain expressed as VAS was also analysed per protocol. Continuous variables are reported as median (interquartile range). Mann–Whitney U test and Pearson's χ2 test were used to compare continuous and categorical variables respectively, with two-sided P < 0·050 indicating significance. All statistical calculations were performed using the JMP® version 8.0 software package (SAS Institute, Cary, North Carolina, USA). Results Initially, 61 patients fulfilled the inclusion criteria, but 12 were not randomized for a variety of reasons (Fig. 2). The remaining 49 patients were quasi-randomized to the LC (25 patients) or SPC (24) group. Two patients in the LC group and one in the SPC group did not receive the allocated intervention because their procedure was converted to open surgery owing to the peroperative finding of cholecystitis. Median follow-up was 18 (11–16) months. The two groups were similar with regard to age, sex, BMI and preoperative diagnosis (Table 1). Fig. 2 Open in new tabDownload slide Flow of participants through each stage of the randomized trial. CBD, common bile duct; LC, four-port laparoscopic cholecystectomy; SPC, single-port cholecystectomy Table 1 Patient characteristics . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ * Values are median (interquartile range). BMI, body mass index. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Table 1 Patient characteristics . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ * Values are median (interquartile range). BMI, body mass index. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Operative data No extra skin incisions or additional ports were needed in either group. There were no perioperative port-related or surgical complications. The final analyses revealed no significant differences between the two groups in terms of operating time (Table 2). The cost of the port devices in the SPC group was £100 per patient, compared with £395 in the LC group. Table 2 Comparison of operative results . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 * Values are median (interquartile range). VAS, visual analogue scale; WBC, white blood cell. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Table 2 Comparison of operative results . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 * Values are median (interquartile range). VAS, visual analogue scale; WBC, white blood cell. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Postoperative outcome The VAS score at 09.00 hours on the day after surgery was significantly lower in the SPC group than in the LC group: 24 (12–38) versus 45 (33–57) mm (P = 0·002). In per-protocol analysis the VAS scores were 24 (12–38) and 44 (32–59) mm respectively (P = 0·002). The rate of analgesic use was also significantly lower in the SPC group (9 of 24 versus 19 of 25; P = 0·007). There were no significant differences in postoperative blood test results or length of hospital stay. There were no postoperative complications including wound infection in either group. Discussion In this prospective study SPC reduced postoperative pain compared with conventional LC. Several factors may affect postoperative pain, and it is well known that incision length is the most important determinant. However, many reports, including a meta-analysis, have shown no differences in terms of both postoperative VAS score and the requirement for analgesia between four-port versus three-port cholecystectomy11–15, four-port versus two-port series16,17, and single-incision versus minilaparoscopic approach18. In the present trial the umbilical incisions were kept strictly to 1·5 cm in non-obese patients, the same size as the umbilical incision in conventional four-port LC. Thus, the difference in pain scores was probably due to the three extra incisions for 5-mm ports. However, a limitation of this investigation is that it was not a randomized double-blind study. In particular, outcome assessment was not blinded and patients were aware of the type of surgery they had undergone. Safety is the most important consideration when a new surgical method is developed, and it is important to note that there were no intraoperative or immediate postoperative complications in either group. However, longer follow-up is needed to evaluate postoperative complications fully and a larger sample size would be needed to provide robust data. The present study was not powered to investigate short- or long-term complications of SPC. In this small series it was encouraging that no additional port was required in any patient, because all procedures were considered to be safe during surgery. With respect to duration of operation, there was a tendency for the SPC procedure to take longer, but the difference was not significant. As reported previously10, the surgical glove method uses a combination of conventional, relatively inexpensive surgical materials, which are easy to prepare. In addition, a single 2·5 × 2·0-cm oval hole was obtained using the wound retractor, which was large enough to pass three 5-mm devices through and small enough to act as a fulcrum for the ports without dissecting any subcutaneous fatty tissue or additional incisions. SPC using a surgical glove port is a promising method, associated with less postoperative pain compared with conventional LC. A large randomized controlled study is needed to evaluate short- and long-term complications, and also differences in use of healthcare resources and associated costs. Acknowledgements The authors declare no conflict of interest. References 1 Inoue H , Takeshita K, Endo M. Single-port laparoscopy assisted appendectomy under local pneumoperitoneum condition . Surg Endosc 1994 ; 8 : 714 – 716 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Matsuda T , Ogura K, Uchida J, Fujita I, Terachi T, Yoshida O. Smaller ports result in shorter convalescence after laparoscopic varicocelectomy . J Urol 1995 ; 153 : 1175 – 1177 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Navarra G , Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy . Br J Surg 1997 ; 84 : 695 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 4 Marescaux J , Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D. Surgery without scars: report of transluminal cholecystectomy in a human being . Arch Surg 2007 ; 142 : 823 – 826 . Google Scholar Crossref Search ADS PubMed WorldCat 5 Asakuma M , Perretta S, Allemann P, Cahill R, Con SA, Solano C et al. Challenges and lessons learned from NOTES cholecystectomy initial experience: a stepwise approach from the laboratory to clinical application . J Hepatobiliary Pancreat Surg 2009 ; 16 : 249 – 254 . Google Scholar Crossref Search ADS PubMed WorldCat 6 Dallemagne B , Perretta S, Allemann P, Asakuma M, Marescaux J. Transgastric hybrid cholecystectomy . Br J Surg 2009 ; 96 : 1162 – 1166 . Google Scholar Crossref Search ADS PubMed WorldCat 7 Mutter D , Leroy J, Cahill R, Marescaux J. A simple technical option for single-port cholecystectomy . Surg Innov 2008 ; 15 : 332 – 333 . Google Scholar Crossref Search ADS PubMed WorldCat 8 Leroy J , Cahill RA, Asakuma M, Dallemagne B, Marescaux J. Single-access laparoscopic sigmoidectomy as definitive surgical management of prior diverticulitis in a human patient . Arch Surg 2009 ; 144 : 173 – 179 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 9 Aitken RC . Measurement of feelings using visual analogue scales . Proc R Soc Med 1969 ; 62 : 989 – 993 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 10 Hayashi M , Asakuma M, Komeda K, Miyamoto Y, Hirokawa F, Tanigawa N. Effectiveness of a surgical glove port for single port surgery . World J Surg 2010 ; 34 : 2487 – 2489 . Google Scholar Crossref Search ADS PubMed WorldCat 11 Sun S , Yang K, Gao M, He X, Tian J, Ma B. Three-port versus four-port laparoscopic cholecystectomy: meta-analysis of randomized clinical trials . World J Surg 2009 ; 33 : 1904 – 1908 . Google Scholar Crossref Search ADS PubMed WorldCat 12 Trichak S . Three-port vs standard four-port laparoscopic cholecystectomy . Surg Endosc 2003 ; 17 : 1434 – 1436 . Google Scholar Crossref Search ADS PubMed WorldCat 13 Cerci C , Tarhan OR, Barut I, Bülbül M. Three-port versus four-port laparoscopic cholecystectomy . Hepatogastroenterology 2007 ; 54 : 15 – 16 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 14 Kumar M , Agrawal CS, Gupta RK. Three-port versus standard four-port laparoscopic cholecystectomy: a randomized controlled clinical trial in a community-based teaching hospital in eastern Nepal . JSLS 2007 ; 11 : 358 – 362 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 15 Gupta A , Shrivastava UK, Kumar P, Burman D. Minilaparoscopic versus laparoscopic cholecystectomy: a randomised controlled trial . Trop Gastroenterol 2005 ; 26 : 149 – 151 . Google Scholar PubMed OpenURL Placeholder Text WorldCat 16 Poon CM , Chan KW, Lee DW, Chan KC, Ko CW, Cheung HY et al. Two-port versus four-port laparoscopic cholecystectomy . Surg Endosc 2003 ; 17 : 1624 – 1627 . Google Scholar Crossref Search ADS PubMed WorldCat 17 Leung KF , Lee KW, Cheung TY, Leung LC, Lau KW. Laparoscopic cholecystectomy: two-port technique . Endoscopy 1996 ; 28 : 505 – 507 . Google Scholar Crossref Search ADS PubMed WorldCat 18 Lee PC , Lo C, Lai PS, Chang JJ, Huang SJ, Lin MT et al. Randomized clinical trial of single-incision laparoscopic cholecystectomy versus minilaparoscopic cholecystectomy . Br J Surg 2010 ; 97 : 1007 – 1012 . Google Scholar Crossref Search ADS PubMed WorldCat Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png British Journal of Surgery Oxford University Press

Impact of single-port cholecystectomy on postoperative pain

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Oxford University Press
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Copyright © 2022 BJS Society Ltd.
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0007-1323
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1365-2168
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10.1002/bjs.7486
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Abstract

Abstract Background This study compared postoperative pain following four-port laparoscopic cholecystectomy (LC) and single-port cholecystectomy (SPC). Method This prospective, quasi-randomized, single-centre trial focusing on postoperative pain included 49 patients undergoing elective surgery with either a conventional LC, or SPC using a surgical glove port. Postoperative pain was evaluated using a visual analogue scale (VAS) and postoperative analgesic use as primary outcome measures. Total duration of operation, length of hospital stay, blood test results on the day after surgery and total port cost were secondary outcome measures. Results Twenty-five LCs and 24 SPCs were undertaken. The VAS score on day 1 after surgery was significantly less in the SPC group than in the LC group: median (range) 24 (12–38) versus 45 (33–57) mm (P = 0·002). Significantly fewer patients in the SPC group required analgesia (9 of 24 versus 19 of 25 in the LC group; P = 0·007). There were no significant differences in total duration of operation, length of hospital stay, and blood test results on the day after surgery. Conclusion Single-port surgery using a surgical glove port reduces postoperative pain compared with conventional LC. Registration number: UMIN000002539 (http://www.umin.ac.jp/ctr/index.htm). Introduction Single-port surgery was first reported in 19941–3. However, the timing seemed premature for surgeons and society, and the concept faded. In the 21st century, a new idea, natural orifice transluminal endoscopic surgery (NOTES), was introduced, providing a good opportunity for surgeons to rethink minimally invasive procedures4–6. Now, attention is again being focused on single-port surgery, whereas the adoption of NOTES has slowed owing to difficulties with the development of new devices, as well as ethical and economic concerns. A preliminary series of single-port cholecystectomy (SPC) and clinical use of single-port procedures have been reported7,8. However, the superiority of SPC over conventional laparoscopic cholecystectomy (LC) is not yet evident. Surgeons may be sceptical about SPC because of concerns about high cost and patient safety. In addition, as conventional three- or four-port cholecystectomy is well established, it is difficult for the general surgeon to imagine an even less invasive surgical approach. A smaller incision is undoubtedly less invasive; this has already been proven by the paradigm shift from open to laparoscopic surgery. However, the effects of small-incision SPC compared with conventional cholecystectomy have not yet been fully investigated. The present study was undertaken to assess the effectiveness of SPC using a surgical glove port compared with conventional LC in terms of postoperative pain. Methods All patients scheduled to undergo cholecystectomy for clinically benign gallbladder disease at this institution were enrolled in the trial between June 2009 and December 2009. Men and women aged 20–85 years who provided written informed consent were included. Patients with common bile duct stones diagnosed before or during surgery, those who had undergone upper abdominal surgery previously, and emergency presentations were excluded from the study. The study protocol was approved by the institutional review board. An English-language summary of the protocol was submitted to the Clinical Trials Registry managed by the University Hospital Medical Information Network in Japan (registration number UMIN000002539; http://www.umin.ac.jp/ctr/index.htm). Quasi-randomization and endpoints Allocation to SPC or LC was based solely on day of the week; SPCs were performed on Fridays and LCs on the other days. No factor that could affect surgical difficulty, such as disease, body mass index (BMI) and inflammation, was considered in the choice of procedure. There was no attempt to randomize patients blindly, and patient requests for a particular procedure (either SPC or conventional LC) were honoured. The primary endpoint was postoperative pain evaluated by visual analogue scale (VAS) scores and postoperative analgesic use. Before surgery, all patients were taught how to score pain on the VAS (0 mm, no pain; 100 mm, maximal pain)9, and they were clearly told that they would not be given analgesics during the postoperative period unless they asked for them. All VAS scoring was done by the attending nurse at 09.00 hours on the day after surgery. Secondary outcome measures were the total duration of operation, length of hospital stay, and blood test results on the day after operation. Operative technique All operations were performed by two surgeons. Each had performed more than 50 conventional LCs and had no experience with SPC before starting this trial. For both SPC and LC, all patients were fasted from the morning of the day of operation. Operations were done under general anaesthesia without epidural anaesthesia. An ultrasonic dissector was not used in either group. In all patients, the abdominal space was lavaged with 1000 ml saline at the end of the procedure; no local anaesthesia was applied to the wound and no drain was placed. Intraoperative cholangiography was performed in all patients except those scheduled for cholecystectomy because of gallbladder polyps and those who had undergone preoperative endoscopic retrograde cholangiopancreatography. Laparoscopic cholecystectomy LC was done using four trocars, with the patient in the reverse Trendelenburg position and the surgeon positioned to the left of the patient. First, a vertical 1·5-cm incision was made in the middle of the umbilicus and a 12-mm trocar inserted, after which pneumoperitoneum was created. Another 5-mm trocar was placed in the mid-epigastrium, and two 5-mm trocars were placed in the right upper abdomen, two fingerbreadths below the right costal margin in the mid-clavicular and mid-axillary lines. Single-port cholecystectomy A single surgeon performed all SPCs. The patient was placed in the French position with the surgeon between the legs, and the first assistant controlled the optics on the left side of the patient. A surgical glove port was used as reported previously10. In brief, the operation started with a skin incision at the umbilicus, exactly 1·5 cm long for patients with a BMI of less than 25 kg/m2 and 2·0 cm long for those with a higher BMI (Video S1, supporting information). Subcutaneous dissection was not performed in any patient. A 2/0 bladed absorbable thread was placed on the fascia for later closure to prevent umbilical hernia. Subsequently, an Alexis® wound retractor (XS size; Applied Medical, Rancho Santa Margarita, California, USA) was installed in the umbilical wound and used to dilate the wound, creating a single free oval hole approximately 2·5 × 2·0 cm in diameter. A non-powdered surgical glove was attached to the wound retractor, and was shown to be airtight. The tips of the glove's thumb, middle and small fingers were cut, and a 5-mm slim trocar (LiNA Medical, Glostrup, Denmark) was inserted into each (Fig. 1a). The assistant inserted a semiflexible laparoscopic camera (LTFVH; Olympus, Tokyo, Japan) via the middle-finger 5-mm port. The abdominal cavity was checked, and a 2/0 nylon thread with a straight needle then placed from the epigastric area to elevate the falciform ligament. This technique allowed the operator to obtain good working space around Calot's triangle. Cholecystectomy was performed using a grasper in the left hand and an Opti 4™ (Covidien, Norwalk, Connecticut, USA) in the right hand (Fig. 1b). This device has multiple functions in one instrument, such as suction, irrigation and a dissection hook. Intraoperative cholangiography was performed via the surgical glove port without adding any other port or puncture. Fig. 1 Open in new tabDownload slide a Set-up of the surgical glove port; three slim ports were inserted via the finger tips. Pneumoperitoneum was controlled by a carbon dioxide insufflator connected to a small finger. b Operative view; separation of the trocars allowed full movement of instruments Statistical analysis The study started without a formal sample size calculation because of lack of data. For the first five patients in each group in this study, the mean VAS score was 25 for the SPC group and 40 for the LC group (median 22 and 38 respectively). This suggested that SPC may decrease postoperative pain by 37 per cent. The sample size required was 22 patients in each group (total 44) to detect a significant difference using a two-tailed test with a type I error of 5 per cent and statistical power of 80 per cent. Allowing for a 5 per cent dropout rate, the total number of patients to be included was set at 46. All data were analysed on an intention-to-treat basis, and postoperative pain expressed as VAS was also analysed per protocol. Continuous variables are reported as median (interquartile range). Mann–Whitney U test and Pearson's χ2 test were used to compare continuous and categorical variables respectively, with two-sided P < 0·050 indicating significance. All statistical calculations were performed using the JMP® version 8.0 software package (SAS Institute, Cary, North Carolina, USA). Results Initially, 61 patients fulfilled the inclusion criteria, but 12 were not randomized for a variety of reasons (Fig. 2). The remaining 49 patients were quasi-randomized to the LC (25 patients) or SPC (24) group. Two patients in the LC group and one in the SPC group did not receive the allocated intervention because their procedure was converted to open surgery owing to the peroperative finding of cholecystitis. Median follow-up was 18 (11–16) months. The two groups were similar with regard to age, sex, BMI and preoperative diagnosis (Table 1). Fig. 2 Open in new tabDownload slide Flow of participants through each stage of the randomized trial. CBD, common bile duct; LC, four-port laparoscopic cholecystectomy; SPC, single-port cholecystectomy Table 1 Patient characteristics . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ * Values are median (interquartile range). BMI, body mass index. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Table 1 Patient characteristics . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Age (years)* 66 (55–72) 57 (47–62) 0·061 Sex ratio (M : F) 13 : 12 11 : 13 0·779‡ BMI (kg/m2)* 24·1 (20·4–25·9) 24·0 (21·4–27·1) 0·332 Disease  Cholecystolithiasis 22 20 0·641‡  Acute cholecystitis 3 2 0·603‡  Polyp 1 1 0·977‡  Adenomyomatosis 4 5 0·763‡ Conversion to open surgery 2 1 0·527‡ * Values are median (interquartile range). BMI, body mass index. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Operative data No extra skin incisions or additional ports were needed in either group. There were no perioperative port-related or surgical complications. The final analyses revealed no significant differences between the two groups in terms of operating time (Table 2). The cost of the port devices in the SPC group was £100 per patient, compared with £395 in the LC group. Table 2 Comparison of operative results . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 * Values are median (interquartile range). VAS, visual analogue scale; WBC, white blood cell. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Table 2 Comparison of operative results . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 . Laparoscopic cholecystectomy (n = 25) . Single-port cholecystectomy (n = 24) . P† . Duration of operation (min)* 100 (71–125) 110 (85–132) 0·433 Intraoperative cholangiography 14 12 0·562‡ Additional port 0 0 Postoperative use of analgesia 19 9 0·007‡ VAS score* 45 (33–57) 24 (12–38) 0·002 Hospital stay (days)* 3 (2–6) 3 (2–4) 0·352 C-reactive protein (mg/dl)* 2·16 (0·45–3·94) 1·54 (0·63–2·65) 0·867 WBC count (per µl)* 9260 (6130–10 735) 8310 (7470–10 140) 0·764 * Values are median (interquartile range). VAS, visual analogue scale; WBC, white blood cell. † Mann–Whitney U test, except ‡ Pearson's χ2 test. Open in new tab Postoperative outcome The VAS score at 09.00 hours on the day after surgery was significantly lower in the SPC group than in the LC group: 24 (12–38) versus 45 (33–57) mm (P = 0·002). In per-protocol analysis the VAS scores were 24 (12–38) and 44 (32–59) mm respectively (P = 0·002). The rate of analgesic use was also significantly lower in the SPC group (9 of 24 versus 19 of 25; P = 0·007). There were no significant differences in postoperative blood test results or length of hospital stay. There were no postoperative complications including wound infection in either group. Discussion In this prospective study SPC reduced postoperative pain compared with conventional LC. Several factors may affect postoperative pain, and it is well known that incision length is the most important determinant. However, many reports, including a meta-analysis, have shown no differences in terms of both postoperative VAS score and the requirement for analgesia between four-port versus three-port cholecystectomy11–15, four-port versus two-port series16,17, and single-incision versus minilaparoscopic approach18. In the present trial the umbilical incisions were kept strictly to 1·5 cm in non-obese patients, the same size as the umbilical incision in conventional four-port LC. Thus, the difference in pain scores was probably due to the three extra incisions for 5-mm ports. However, a limitation of this investigation is that it was not a randomized double-blind study. In particular, outcome assessment was not blinded and patients were aware of the type of surgery they had undergone. Safety is the most important consideration when a new surgical method is developed, and it is important to note that there were no intraoperative or immediate postoperative complications in either group. However, longer follow-up is needed to evaluate postoperative complications fully and a larger sample size would be needed to provide robust data. The present study was not powered to investigate short- or long-term complications of SPC. In this small series it was encouraging that no additional port was required in any patient, because all procedures were considered to be safe during surgery. With respect to duration of operation, there was a tendency for the SPC procedure to take longer, but the difference was not significant. As reported previously10, the surgical glove method uses a combination of conventional, relatively inexpensive surgical materials, which are easy to prepare. In addition, a single 2·5 × 2·0-cm oval hole was obtained using the wound retractor, which was large enough to pass three 5-mm devices through and small enough to act as a fulcrum for the ports without dissecting any subcutaneous fatty tissue or additional incisions. SPC using a surgical glove port is a promising method, associated with less postoperative pain compared with conventional LC. A large randomized controlled study is needed to evaluate short- and long-term complications, and also differences in use of healthcare resources and associated costs. Acknowledgements The authors declare no conflict of interest. References 1 Inoue H , Takeshita K, Endo M. Single-port laparoscopy assisted appendectomy under local pneumoperitoneum condition . Surg Endosc 1994 ; 8 : 714 – 716 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Matsuda T , Ogura K, Uchida J, Fujita I, Terachi T, Yoshida O. Smaller ports result in shorter convalescence after laparoscopic varicocelectomy . J Urol 1995 ; 153 : 1175 – 1177 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Navarra G , Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy . Br J Surg 1997 ; 84 : 695 . 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Surg Endosc 2003 ; 17 : 1624 – 1627 . Google Scholar Crossref Search ADS PubMed WorldCat 17 Leung KF , Lee KW, Cheung TY, Leung LC, Lau KW. Laparoscopic cholecystectomy: two-port technique . Endoscopy 1996 ; 28 : 505 – 507 . Google Scholar Crossref Search ADS PubMed WorldCat 18 Lee PC , Lo C, Lai PS, Chang JJ, Huang SJ, Lin MT et al. Randomized clinical trial of single-incision laparoscopic cholecystectomy versus minilaparoscopic cholecystectomy . Br J Surg 2010 ; 97 : 1007 – 1012 . Google Scholar Crossref Search ADS PubMed WorldCat Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Journal

British Journal of Surgery – Oxford University Press

Published: May 27, 2011

Keywords: cholecystectomy; surgical gloves; postoperative pain; surgical procedures, operative; surgery specialty; laparoscopic cholecystectomy; statistical process control; length of stay; blood tests; analgesics; pain management; analgesia (pain absence); visual analogue pain scale; outcome measures; primary outcome measure; surgical procedures, elective

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