Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

Hospital Authority, Hong Kong

Status: Unknown

Conditions: Appendicitis

Treatments: Procedure: single incision laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01567098

KC/KE-12-0051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy, mentally incapacitated, previous surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

SILS appendectomy

Experimental group

Description:

Single incision laparoscopic appendectomy

Treatment:

Procedure: single incision laparoscopic appendectomy

3 Ports appendectomy

Active Comparator group

Description:

performing appendectomy through conventional 3 incisions on the abdomen

Treatment:

Procedure: single incision laparoscopic appendectomy