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

This study has been terminated.
(Planned interim analysis showed worse outcomes in experimental group)
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00997516
First received: October 15, 2009
Last updated: August 6, 2014
Last verified: August 2014
  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 After Surgery [ Time Frame: 12 hours post-surgery ] [ Designated as safety issue: No ]
    Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.


Secondary Outcome Measures:
  • Operative Time [ Time Frame: up to 6 hours ] [ Designated as safety issue: Yes ]
    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.

  • Procedures Requiring Conversion to Open or Additional Port [ Time Frame: during surgery , up to 6 hours ] [ Designated as safety issue: Yes ]
    Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.

  • Visceral or Vascular Injury [ Time Frame: during surgery, up to 6 hours ] [ Designated as safety issue: Yes ]
    Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.

  • Length of Stay [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
    Number of calendar days the participant was hospitalized.

  • Wound Infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.

  • Deep Space Infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.

  • Wound Seroma [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.

  • Time to Return to Work [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of calendar days between participants' discharge from the hospital and the first day back at work.

  • Readmission Within 30 Days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Number of participants readmitted to the hospital within 30 days of surgery

  • Body Image Score at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.

    Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?


  • Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.

    Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)



Enrollment: 75
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: December 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: August 6, 2014
Last Updated: August 6, 2014
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
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014