MedTrace Logo

Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

NCT00997516 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-08-22

Study results available
· View outcomes & findings →

Summary

Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other potential benefits are faster recovery, less pain, and fewer wound complications. The term SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field closer to surgery that is bloodless, incisionless, and painless. Despite the hype, prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS procedures have generally been limited to case reports and small case series that lack controls. The investigators propose to conduct a prospective, randomized, single-center trial of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute appendicitis. Primary end-points are operative time, complication rate, postoperative pain, recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS appendectomy is equivalent to laparoscopic appendectomy with respect to operative time, complication rate, postoperative pain, and recovery time while providing a better cosmetic outcome.

Conditions

  • Appendicitis

Interventions

PROCEDURE

SILS appendectomy

Use of SILSPort to perform laparoscopic appendectomy

PROCEDURE

conventional laparoscopic appendectomy

conventional laparoscopic removal of the appendix

Sponsors & Collaborators

Principal Investigators

  • Jonathan T. Carter, M.D. · UCSF Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-12-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997516 on ClinicalTrials.gov