A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
Not Applicable
Completed
- Conditions
- Cholelithiasis
- Interventions
- Procedure: Single Incision Laparoscopic Cholecystectomy (SILC)Procedure: Four Ports Laparoscopic Cholecystectomy (4PLC)
- 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
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- Arm && Interventions
Group Intervention Description Single Incision Cholesystectomy (SILC) Single Incision Laparoscopic Cholecystectomy (SILC) Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy. Four Ports Cholecystectomy (4PCL) Four Ports Laparoscopic Cholecystectomy (4PLC) Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank.
- 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