NCT03018964

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
3.1 years until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

January 8, 2017

Last Update Submit

April 2, 2019

Conditions

Cholecystectomy, Laparoscopic

Keywords

Single incisionSolo surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • complications in both groups

    average 2 weeks

  • Conversion rate

    intraoperative

  • Incisional hernia

    average 6 months

  • Wound, back, and shoulder pain

    postoperative 6 hr, 24 hr, 2 weeks after the operation

  • Postoperative adverse symptoms after SILC

    average 2weeks after discharge

  • +2 more secondary outcomes

Study Arms (2)

Solo-SILC

EXPERIMENTAL

Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC

Procedure: Solo surgery

Ca-SILC

ACTIVE COMPARATOR

No solo surgery, operation with a camera operator in SILC

Procedure: operation with a camera operator in SILC

Interventions

Solo surgeryPROCEDURE

Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy

Solo-SILC
operation with a camera operator in SILCPROCEDURE

conventional single incision laparoscopic cholecystectomy with a scopist

Ca-SILC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Mirizzi syndrome
  • unstable vital sign
  • no compliance
  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 9171771RESULT

  • 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.

    PMID: 20174950RESULT

  • 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.

    PMID: 21367381RESULT

  • 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.

    PMID: 22173546RESULT

  • 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.

    PMID: 22083331RESULT

  • 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.

    PMID: 24368985RESULT

  • 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.

    PMID: 23990155RESULT

  • 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.

    PMID: 22408354RESULT

  • 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.

    PMID: 24282363RESULT

  • 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.

    PMID: 25336816RESULT

  • 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.

    PMID: 20727831RESULT

  • 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.

    PMID: 8000648RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Soyeon Ahn, Ph.D.

    Medical Research Collaboration Center Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YoungRok Choi, M.D.

CONTACT

+821093212477choiyoungrok@gmail.com

Ho-Jeong Jeong, R.N.

CONTACT

+821095267743r1441@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2017

First Posted

January 12, 2017

Study Start

March 1, 2020

Primary Completion

January 1, 2021

Study Completion

August 1, 2022

Last Updated

April 4, 2019

Record last verified: 2019-04