Solo Single Incision Laparoscopic Cholecystectomy

April 2, 2019 updated by: YoungRok Choi, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Solo-SILC
Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC
Procedure: Solo surgery
Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
ACTIVE_COMPARATOR: Ca-SILC
No solo surgery, operation with a camera operator in SILC
Procedure: operation with a camera operator in SILC
conventional single incision laparoscopic cholecystectomy with a scopist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)
Time Frame: average 2 weeks
intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy
average 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications in both groups
Time Frame: average 2 weeks
intraoperative and postoperative complications
average 2 weeks
Conversion rate
Time Frame: intraoperative
intraoperative conversion rate to open or additional port surgery
intraoperative
Incisional hernia
Time Frame: average 6 months
Umbilical incisional hernia incidence
average 6 months
Wound, back, and shoulder pain
Time Frame: postoperative 6 hr, 24 hr, 2 weeks after the operation
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
Time Frame: average 2weeks after discharge
Diet change, post-cholecystectomy diarrhea
average 2weeks after discharge
number of participant with abnormal laboratory values
Time Frame: average 2weeks after discharge
postoperative laboratory findings on visiting outpatient's clinic
average 2weeks after discharge
Operator's workload
Time Frame: intraoperative
Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Gyeongsang National University Hospital
Chungbuk National University Hospital

Investigators

  • Principal Investigator: Soyeon Ahn, Ph.D., Medical Research Collaboration Center Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

January 8, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILC_HoOp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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