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

Primary Purpose

Appendicitis, Laparoscopic

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

nonsolo LA

solo LA

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Solo surgery, Camera holder, Laparoscopic Appendectomy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

LC & nonsolo approach

LC & solo approach

Arm Description

The surgical intervention is nonsolo LC

The surgical intervention is solo LC.

Outcomes

Primary Outcome Measures

Operation time

Operation time correlates with surgical difficulity.

Secondary Outcome Measures

Pain score

Daily pain scores are assessed

Full Information

NCT ID

NCT03224364

First Posted

July 18, 2017

Last Updated

July 18, 2017

Sponsor

Say-June Kim

1. Study Identification

Unique Protocol Identification Number

NCT03224364

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2017 (Anticipated)

Primary Completion Date

December 31, 2017 (Anticipated)

Study Completion Date

March 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Say-June Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendicitis, Laparoscopic

Keywords

Solo surgery, Camera holder, Laparoscopic Appendectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LC & nonsolo approach

Arm Type

Placebo Comparator

Arm Description

The surgical intervention is nonsolo LC

Arm Title

LC & solo approach

Arm Type

Active Comparator

Arm Description

The surgical intervention is solo LC.

Intervention Type

Procedure

Intervention Name(s)

nonsolo LA

Other Intervention Name(s)

Nonsolo laparoscopic appendectomy

Intervention Description

This patient is scheduled to undergo nonsolo laparoscpic appendectomy.

Intervention Type

Procedure

Intervention Name(s)

solo LA

Other Intervention Name(s)

Solo laparoscopic appendectomy

Intervention Description

This patient is scheduled to undergo solo laparoscpic appendectomy.

Primary Outcome Measure Information:

Title

Operation time

Description

Operation time correlates with surgical difficulity.

Time Frame

day 1

Secondary Outcome Measure Information:

Title

Pain score

Description

Daily pain scores are assessed

Time Frame

day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patients planned to undergo elective laparoscopic appendectomy Benign gallbladder diseases requiring surgery The patients who are indicated for single-port laparoscopic appendectomy. Exclusion Criteria: the patients with complicated cholecystitis the patients with the gallbladder with a thickness more than 4mm. the patients who are expected to have severe peritoneal adhesion. the patients with malignant gallbladder diseases. the patients whose operation appears to need human assistant(s)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Say-June Kim

Phone

+821087737616

sayjunekim@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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