A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

Consorci Sanitari Integral

Status: Completed

Conditions: Cholelithiasis

Treatments: Procedure: Four Ports Laparoscopic Cholecystectomy (4PLC); Procedure: Single Incision Laparoscopic Cholecystectomy (SILC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02375529

11/19

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Single Incision Cholesystectomy (SILC)

Experimental group

Description:

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.

Treatment:

Procedure: Single Incision Laparoscopic Cholecystectomy (SILC)

Four Ports Cholecystectomy (4PCL)

Active Comparator group

Description:

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.

Treatment:

Procedure: Four Ports Laparoscopic Cholecystectomy (4PLC)