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

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03224364
• Other study ID #: SSAP-1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: July 18, 2017
• Start date: August 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: July 2017
• Source: Daejeon St. Mary's hospital
• Contact: Say-June Kim
• Phone: +821087737616
• Email: sayjunekim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Appendicitis
• Laparoscopic

Intervention

Procedure:
• nonsolo LA
This patient is scheduled to undergo nonsolo laparoscpic appendectomy.
• solo LA
This patient is scheduled to undergo solo laparoscpic appendectomy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Say-June Kim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	Operation time correlates with surgical difficulity.	day 1
Secondary	Pain score	Daily pain scores are assessed	day 3