Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

September 3, 2020 updated by: Byung Mo Kang, Kyunghee University Medical Center

Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis

The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Study Type

Interventional

Enrollment (Actual)

194

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 Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 134-727
        • Kyung Hee University School of Medicine, Neo Medical Center

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

7 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically diagnosed acute appendicitis

Exclusion Criteria:

  • Age less than 7 or more than 75 years old
  • Gangrenous appendicitis
  • Combined generalized peritonitis
  • ASA score more than 3 point
  • Pregnant women
  • Cases requiring draining tube

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single port
Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.
Procedure: Single port laparoscopic appendectomy
Single port through the transumbilical 2-cm incision
Other Names:
  • single port laparoscopic surgery
Active Comparator: 3 port
3 port laparoscopic appendectomy was done by conventional method
Procedure: 3 port laparoscopic appendectomy
3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
Other Names:
  • conventional laparoscopic appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 1 month
30 day morbidity and mortality
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 1 day
Operative time
1 day
Efficacy
Time Frame: 2 days
Postoperative pain score
2 days
Efficacy
Time Frame: 2 days
Postoperative functional recovery
2 days
Efficacy
Time Frame: 7 days
Duration of postoperative hospital stay
7 days
Efficacy
Time Frame: 7 days
Cost
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Collaborators

KyungHee University School of Medicine, Korea

Investigators

  • Principal Investigator: Suk Hwan Lee, MD. PhD, Kyung Hee University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • khnmc IRB 2009-026

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.

Clinical Trials on Appendicitis

Clinical Trials on Single port laparoscopic appendectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe