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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborator: |
Covidien |
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00997516 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Appendicitis |
Procedure: SILS appendectomy Procedure: conventional laparoscopic appendectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis |
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SILS appendectomy
The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinical evaluation and CT of the abdomen/pelvis.
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Procedure: SILS appendectomy
Use of SILSPort to perform laparoscopic appendectomy
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Active Comparator: Conventional laparoscopic appendectomy
The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinical evaluation and CT of the abdomen/pelvis.
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Procedure: conventional laparoscopic appendectomy
conventional laparoscopic removal of the appendix
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Suspected acute appendicitis on clinical and radiographic (CT) grounds
Exclusion Criteria:
Contacts and Locations| Contact: Jonathan T Carter, M.D. | 415-476-0974 | jonathan.carter@ucsfmedctr.org |
| Contact: Hobart W Harris, M.D. | 415 353-2161 | hobart.harris@ucsfmedctr.org |
| United States, California | |
| University of California, San Francisco | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Jonathan T. Carter, M.D. 415-476-0974 jonathan.carter@ucsfmedctr.org | |
| Contact: Hobart W Harris, M.D. hobart.harris@ucsfmedctr.org | |
| Principal Investigator: Jonathan T. Carter, M.D. | |
| UCSF Medical Center | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Jonathan T Carter, MD 415-476-0974 jonathan.carter@ucsfmedctr.org | |
| Principal Investigator: Jonathan T Carter, MD | |
| Principal Investigator: | Jonathan T. Carter, M.D. | UCSF Department of Surgery |
More Information
| Responsible Party: | Jonathan Carter, M.D. Assistant Professor of Surgery, University of California |
| ClinicalTrials.gov Identifier: | NCT00997516 History of Changes |
| Other Study ID Numbers: | UCSF SILS 01 |
| Study First Received: | October 15, 2009 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Laparoscopy Appendicitis Single-incision laparoscopic surgery SILS |
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Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Disease Attributes Pathologic Processes |