Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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:
|
|
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:
|
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 |
Inclusion Criteria:
- appendicitis score >5, imaging showed no complication from appendicitis
Exclusion Criteria:
- pregnancy, mentally incapacitated, previous surgery
Contacts and Locations| Contact: Canon KO Chan, F.R.C.S.Ed | (+852)29588887 | chankoc@gmail.com |
| Hong Kong | |
| Department of Surgery | Not yet recruiting |
| Kowloon, Hong Kong | |
| Contact: Canon KO Chan, F.R.C.S Ed. chankoc@gmail.com | |
| 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 May 22, 2013