A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
- Conditions
- Cholelithiasis
- Registration Number
- NCT02375529
- Lead Sponsor
- Consorci Sanitari Integral
- Brief Summary
Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.
Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- age higher than 18 and lower than 80
- American Society of Anesthesiologists class (ASA) I-II,
- absence of any previous anesthetic complication,
- accompaniment by a responsible adult during 24 hours,
- symptomatic gallstones candidate to cholecystectomy
- and a signed informed consent.
- a Body Mass Index (BMI) higher than 35,
- any laparoscopic contraindication,
- acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
- anti-inflammatory allergy
- psychiatric history that could hinder ambulatory procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method evolution of postoperative pain 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery
- Secondary Outcome Measures
Name Time Method
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