Clinical Trials Directory

Trials / Unknown

UnknownNCT01567098

Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Hospital Authority, Hong Kong · Other Government
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREsingle incision laparoscopic appendectomyperforming appendectomy through a single incision in the abdomen

Timeline

Start date
2012-06-01
Primary completion
2013-06-01
Completion
2014-06-01
First posted
2012-03-30
Last updated
2012-05-30

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT01567098. Inclusion in this directory is not an endorsement.