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

July 18, 2017 updated by: Say-June Kim

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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

13 years to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
Placebo Comparator: LC & nonsolo approach
The surgical intervention is nonsolo LC
Procedure: nonsolo LA
This patient is scheduled to undergo nonsolo laparoscpic appendectomy.
Other Names:
  • Nonsolo laparoscopic appendectomy
Active Comparator: LC & solo approach
The surgical intervention is solo LC.
Procedure: solo LA
This patient is scheduled to undergo solo laparoscpic appendectomy.
Other Names:
  • Solo laparoscopic appendectomy

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

Say-June Kim

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 (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSAP-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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