Solo Single Incision Laparoscopic Cholecystectomy

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

A Prospective Multicenter Randomized Controlled Study for The Safety of Single Incision Laparoscopic Cholecystectomy With a Camera Holder Versus With a Camera Operator

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03018964
• Other study ID #: SILC_HoOp
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: August 2022

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: YoungRok Choi, M.D.
• Phone: +821093212477
• Email: choiyoungrok[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: August 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patient need laparoscopic cholecystectomy (check the possibility of routine application of Solo-SILC in clinical practice)

Exclusion Criteria:

• Mirizzi syndrome

• unstable vital sign

• no compliance

• no consent

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic
• Surgical Wound

Intervention

Procedure:
• Solo surgery
Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
• operation with a camera operator in SILC
conventional single incision laparoscopic cholecystectomy with a scopist

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chungbuk National University Hospital, Gyeongsang National University Hospital

References & Publications (12)

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. — View Citation

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 — View Citation

Gillen S, Pletzer B, Heiligensetzer A, Wolf P, Kleeff J, Feussner H, Fürst 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 2 — View Citation

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 — View Citation

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 prel — View Citation

Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 May;84(5):695. — View Citation

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 — View Citation

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): — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 tr — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	complications in both groups	intraoperative and postoperative complications	average 2 weeks
Secondary	Conversion rate	intraoperative conversion rate to open or additional port surgery	intraoperative
Secondary	Incisional hernia	Umbilical incisional hernia incidence	average 6 months
Secondary	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
Secondary	Postoperative adverse symptoms after SILC	Diet change, post-cholecystectomy diarrhea	average 2weeks after discharge
Secondary	number of participant with abnormal laboratory values	postoperative laboratory findings on visiting outpatient's clinic	average 2weeks after discharge
Secondary	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