Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

May 28, 2012 updated by: Canon KO Chan, F.R.C.S. Ed., Hospital Authority, Hong Kong

Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy: A Single Center Prospective Randomized Trial

A randomized trial to study the null hypothesis:" single incision appendectomy does not take longer operation time when compared to conventional 3-port appendectomy". The study will be carried out in a tertiary referral center in Hong Kong with a catchment population of 1 million.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Since the introduction of single incision laparoscopic surgery (SILS), this approach has become more popular and various case series and reports had described its feasibility in many general surgical procedures including appendectomy, cholecystectomy, and colectomy. Despite this, strong evidence in support of SILS to be equivalent or even superior to conventional multi-port approaches remain scarce, although there are case series and comparative studies with promising results in cholecystectomy and colectomy. There are many case series available stating that single incision appendectomy may be a feasible alternative to conventional approach, but may be at the expense of a longer operating time and a higher post operative wound pain score. A recent randomized trial by St. Peter et al. was the first to test the feasibility of this approach to standard 3-port approach in appendectomy in children. Under randomized settings of this trial the single incision appendectomy produced longer operating times and resulted in greater charges. However, the primary outcome measure in this trial was wound infection and the result showed no significant differences between the two approaches. The answer to whether single incision appendectomy produces a longer operating time when compared to conventional 3-port approach remained undetermined, in particular the adult population, and therefore a randomized trial design based on operating time as its primary outcome is desired.

Study Type

Interventional

Enrollment (Anticipated)

120

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

  • Name: Canon KO Chan, F.R.C.S.Ed
  • Phone Number: (+852)29588887
  • Email: chankoc@gmail.com

Study Locations

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • appendicitis score >5, imaging showed no complication from appendicitis

Exclusion Criteria:

  • pregnancy, mentally incapacitated, previous surgery

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SILS appendectomy
Single incision laparoscopic appendectomy
Procedure: single incision laparoscopic appendectomy
performing appendectomy through a single incision in the abdomen
Other Names:
  • SILS
  • single port appendectomy
  • one port appendectomy
ACTIVE_COMPARATOR: 3 Ports appendectomy
performing appendectomy through conventional 3 incisions on the abdomen
Procedure: single incision laparoscopic appendectomy
performing appendectomy through a single incision in the abdomen
Other Names:
  • SILS
  • single port appendectomy
  • one port appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
operation time
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Canon KO Chan, F.R.C.S Ed., Hospital Authority

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

June 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (ESTIMATE)

March 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 28, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC/KE-12-0051

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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