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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00997516
First received: October 15, 2009
Last updated: March 7, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pain in the first 12 hours after surgery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative time - defined as the amount of time to perform the operation from skin-incision to application of the dressing. This time is routinely charted by the circulating nurse in the operating room. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • Conversion - defined by the use of incisions and/or trocars in addition to the ones described in the Methods section, or the need to perform an open procedure. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • Visceral or vascular injury - defined as injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection requiring intervention (suture or stapled repair, use of hemostatic agents). [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • Mean pain score over 12 hours - Pain is scored on a scale of 0-10, 10 being the most severe pain imaginable. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Length of stay - Number of calendar days the patient is hospitalized. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Wound infection - Defined as the need for additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 5) Deep space infection - Defined as the need for reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses are classified as deep space infections. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 6) Wound seroma - Defined as an un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 7) Time to return to work - Defined as the number of calendar days between discharge from the hospital and the first day back at work. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Readmission with 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Body Image Score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cosmetic Appearance Scale at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Photo Series Questionnaire at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 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.
Procedure: SILS appendectomy
Use of SILSPort to perform laparoscopic appendectomy
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.
Procedure: conventional laparoscopic appendectomy
conventional laparoscopic removal of the appendix

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Suspected acute appendicitis on clinical and radiographic (CT) grounds

Exclusion Criteria:

  1. Phlegmon, mass, peri-appendicecal abscess, or diffuse peritonitis
  2. Prior open laparotomy with incision through the umbilicus
  3. Body Mass Index > 35
  4. Age <18 years
  5. Mental illness, dementia, or inability to provide informed consent
  6. Chronic pain requiring daily medication (including opiate and NSAIDs)
  7. Pregnancy
  8. Alternative diagnosis found by diagnostic laparoscopy (post-randomization)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997516

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
UCSF Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Covidien
Investigators
Principal Investigator: Jonathan T. Carter, M.D. UCSF Department of Surgery
  More Information

Additional Information:
Publications:
Nguyen NT, Reavis KM, Hinojosa MW, Smith BR, Stamos MJ. A single-port technique for laparoscopic extended stapled appendectomy. Surg Innov 2009;16:78-81.
Edwards C BA. Single incision laparoscopic appendectomy is safe and results in excellent cosmetic outcomes. SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only) 2009.
Chouillard K FA. Single incision appendectomy for acute appendicitis: a preliminary experience. In: SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only); 2009.
Kravetz AJ ID, Kia MA. Initial experience in single-port laparoscopic appendectomies. SAGES 2009 Scientific Session, April 22-29, Phoenix, AZ (abstract only)

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00997516     History of Changes
Other Study ID Numbers: UCSF SILS 01
Study First Received: October 15, 2009
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Laparoscopy
Appendicitis
Single-incision laparoscopic surgery
SILS

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014