Solo and Non-solo Approach for Laparoscopic Appendectomy (SOLOAP)

Not Applicable

• Conditions: Appendicitis; Laparoscopic
• Interventions: Procedure: nonsolo LA; Procedure: solo LA

• Registration Number: NCT03224364
• Lead Sponsor: Say-June Kim

Brief Summary

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

Detailed Description

Laporoscopic appendectomy 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 appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Study Start: 2017-08-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LC & nonsolo approach	nonsolo LA	The surgical intervention is nonsolo LC
LC & solo approach	solo LA	The surgical intervention is solo LC.

Primary Outcome Measures

Name	Time	Method
Operation time	day 1	Operation time correlates with surgical difficulity.

Secondary Outcome Measures

Name	Time	Method
Pain score	day 3	Daily pain scores are assessed