Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Hospital Authority, Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Canon KO Chan, F.R.C.S. Ed., Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT01567098
First received: March 27, 2012
Last updated: May 28, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Appendicitis
Procedure: single incision laparoscopic appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy: A Single Center Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • operation time [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SILS appendectomy
Single incision laparoscopic appendectomy
Procedure: single incision laparoscopic appendectomy
performing appendectomy through a single incision in the abdomen
Other Names:
  • single port appendectomy
  • one port appendectomy
  • SILS
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:
  • single port appendectomy
  • one port appendectomy
  • SILS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy, mentally incapacitated, previous surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567098

Contacts
Contact: Canon KO Chan, F.R.C.S.Ed (+852)29588887 chankoc@gmail.com

Locations
Hong Kong
Department of Surgery Not yet recruiting
Kowloon, Hong Kong
Contact: Canon KO Chan, F.R.C.S Ed.       chankoc@gmail.com   
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Canon KO Chan, F.R.C.S Ed. Hospital Authority
  More Information

Publications:

Responsible Party: Canon KO Chan, F.R.C.S. Ed., Principal Investigator, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT01567098     History of Changes
Other Study ID Numbers: KC/KE-12-0051
Study First Received: March 27, 2012
Last Updated: May 28, 2012
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Appendicitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 23, 2014