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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 November 2012
• Main ID: NCT00997516
• Date of registration: 15/10/2009
• Primary sponsor: University of California, San Francisco
• Public title: Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
• Scientific title: A Randomized, Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
• Date of first enrolment: May 2010
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00997516
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jonathan T Carter, M.D.

• Name: Jonathan T. Carter, M.D.
• Affiliation: UCSF Department of Surgery

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Appendicitis

Intervention(s)

Procedure: conventional laparoscopic appendectomy

Procedure: SILS appendectomy

Primary Outcome(s)

Pain in the first 12 hours after surgery [Time Frame: 12 hours]

Secondary Outcome(s)

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]

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]

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]

Body Image Score at 6 months [Time Frame: 6 months]

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]

Cosmetic Appearance Scale at 6 months. [Time Frame: 6 months]

Length of stay - Number of calendar days the patient is hospitalized. [Time Frame: 14 days]

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]

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]

Photo Series Questionnaire at 6 months. [Time Frame: 6 months]

Readmission with 30 days. [Time Frame: 30 days]

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]

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]

Secondary ID(s)

UCSF SILS 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Covidien