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| Name | Class |
|---|---|
| Chungbuk National University Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
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The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC
This study is a multicenter randomized controlled study. The primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between Solo-SILC group and conventional cholecystectomy group (Ca-SILC).
Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in which a camera operator joins (n=136). .
Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to open surgery or additional port will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solo-SILC | Experimental | Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC |
|
| Ca-SILC | Active Comparator | No solo surgery, operation with a camera operator in SILC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solo surgery | Procedure | Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC) | intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy | average 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| complications in both groups | intraoperative and postoperative complications | average 2 weeks |
| Conversion rate | intraoperative conversion rate to open or additional port surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YoungRok Choi, M.D. | Contact | +821093212477 | choiyoungrok@gmail.com | |
| Ho-Jeong Jeong, R.N. | Contact | +821095267743 | r1441@snubh.org |
| Name | Affiliation | Role |
|---|---|---|
| Soyeon Ahn, Ph.D. | Medical Research Collaboration Center Seoul National University Bundang Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9171771 | Result | Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 May;84(5):695. No abstract available. | |
| 20174950 | Result | Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20. |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| operation with a camera operator in SILC | Procedure | conventional single incision laparoscopic cholecystectomy with a scopist |
|
| intraoperative |
| Incisional hernia | Umbilical incisional hernia incidence | average 6 months |
| Wound, back, and shoulder pain | Access the patient's pain using the visual analog scale | postoperative 6 hr, 24 hr, 2 weeks after the operation |
| Postoperative adverse symptoms after SILC | Diet change, post-cholecystectomy diarrhea | average 2weeks after discharge |
| number of participant with abnormal laboratory values | postoperative laboratory findings on visiting outpatient's clinic | average 2weeks after discharge |
| Operator's workload | Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score | intraoperative |
| 21367381 | Result | Marks J, Tacchino R, Roberts K, Onders R, Denoto G, Paraskeva P, Rivas H, Soper N, Rosemurgy A, Shah S. Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg. 2011 Mar;201(3):369-72; discussion 372-3. doi: 10.1016/j.amjsurg.2010.09.012. |
| 22173546 | Result | Markar SR, Karthikesalingam A, Thrumurthy S, Muirhead L, Kinross J, Paraskeva P. Single-incision laparoscopic surgery (SILS) vs. conventional multiport cholecystectomy: systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1205-13. doi: 10.1007/s00464-011-2051-0. Epub 2011 Dec 16. |
| 22083331 | Result | Phillips MS, Marks JM, Roberts K, Tacchino R, Onders R, DeNoto G, Rivas H, Islam A, Soper N, Gecelter G, Rubach E, Paraskeva P, Shah S. Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc. 2012 May;26(5):1296-303. doi: 10.1007/s00464-011-2028-z. Epub 2011 Nov 15. |
| 24368985 | Result | Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26. |
| 23990155 | Result | Gillen S, Pletzer B, Heiligensetzer A, Wolf P, Kleeff J, Feussner H, Furst A. Solo-surgical laparoscopic cholecystectomy with a joystick-guided camera device: a case-control study. Surg Endosc. 2014 Jan;28(1):164-70. doi: 10.1007/s00464-013-3142-x. Epub 2013 Aug 29. |
| 22408354 | Result | Sasaki K, Watanabe G, Matsuda M, Hashimoto M. Original single-incision laparoscopic cholecystectomy for acute inflammation of the gallbladder. World J Gastroenterol. 2012 Mar 7;18(9):944-51. doi: 10.3748/wjg.v18.i9.944. |
| 24282363 | Result | Chuang SH, Chen PH, Chang CM, Lin CS. Single-incision vs three-incision laparoscopic cholecystectomy for complicated and uncomplicated acute cholecystitis. World J Gastroenterol. 2013 Nov 21;19(43):7743-50. doi: 10.3748/wjg.v19.i43.7743. |
| 25336816 | Result | Sinha R, Yadav AS. Transumbilical single incision laparoscopic cholecystectomy with conventional instruments: A continuing study. J Minim Access Surg. 2014 Oct;10(4):175-9. doi: 10.4103/0972-9941.141502. |
| 20727831 | Result | Saber AA, El-Ghazaly TH, Dewoolkar AV, Slayton SA. Single-incision laparoscopic sleeve gastrectomy versus conventional multiport laparoscopic sleeve gastrectomy: technical considerations and strategic modifications. Surg Obes Relat Dis. 2010 Nov-Dec;6(6):658-64. doi: 10.1016/j.soard.2010.03.004. Epub 2010 Mar 19. |
| 8000648 | Result | Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available. |