Solo and Non-solo Approach for Laparoscopic Cholecystectomy (SOLOGB)

February 20, 2017 updated by: Say-June Kim, Daejeon St. Mary's hospital

A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy

To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Study Type

Interventional

Enrollment (Anticipated)

150

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.

Study Contact

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

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patients planed to undergo elective laparoscopic cholecystectomy
  2. Benign gallbladder diseases requiring surgery
  3. The patients who are indicated for single-port laparoscopic cholecystectomy.

Exclusion Criteria:

  1. the patients with complicated cholecystitis
  2. the patients with the gallbladder with a thickness more than 4mm.
  3. the patients who are expected to have severe peritoneal adhesion.
  4. the patients with malignant gallbladder diseases.
  5. the patients whose operation appears to need human assistant(s)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LC & solo approach
The surgical intervention is solo LC.
Procedure: solo LC
This patient is scheduled to undergo solo laparoscpic cholecystectomy.
Other Names:
  • Solo laparoscopic cholecystectomy
Placebo Comparator: LC & nonsolo approach
The surgical intervention is nonsolo LC.
Procedure: nonsolo LC
This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.
Other Names:
  • Nonsolo laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: day 1
Operation time correlates with surgical difficulity.
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: day 3
Daily pain scores are assessed.
day 3

Collaborators and Investigators

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

Sponsor

Daejeon St. Mary's hospital

Investigators

  • Principal Investigator: Say-June Kim, M.D., Ph.D., Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea

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

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SSGB-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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