Solo and Non-solo Approach for Laparoscopic Cholecystectomy

NCT ID: NCT02978989

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-09-30

Brief Summary

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).

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).

Conditions

Cholecystectomy, Laparoscopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LC & nonsolo approach

The surgical intervention is nonsolo LC.

Group Type: PLACEBO_COMPARATOR

nonsolo LC

Intervention Type: PROCEDURE

This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.

LC & solo approach

The surgical intervention is solo LC.

Group Type: ACTIVE_COMPARATOR

solo LC

Intervention Type: PROCEDURE

This patient is scheduled to undergo solo laparoscpic cholecystectomy.

Interventions

nonsolo LC

This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.

Intervention Type: PROCEDURE

solo LC

This patient is scheduled to undergo solo laparoscpic cholecystectomy.

Intervention Type: PROCEDURE

Other Intervention Names

Nonsolo laparoscopic cholecystectomy; Solo laparoscopic cholecystectomy

Eligibility Criteria

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daejeon St. Mary's hospital

OTHER

Sponsor Role: lead

Responsible Party

Say-June Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Say-June Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea

Central Contacts

Say-June Kim, M.D.,Ph.D.

Role: CONTACT

sayjunekim@gmail.com

+821087737616

Other Identifiers

SSGB-1

Identifier Type: -

Identifier Source: org_study_id