Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

National University Health System (NUHS)

Status: Completed

Conditions: Cholecystolithiasis; Cholangitis; Cholelithiasis; Pancreatitis; Choledocholithiasis

Treatments: Procedure: LC; Procedure: SILC

Study type: Interventional

Funder types: Other

Identifiers

NCT01824186

NHG DSRB 2009/00434

Details and patient eligibility

About

This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.

Full description

As above

Enrollment: 100 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of symptomatic gallstones
• American Society of Anesthesiologists (ASA) score 1 or 2
• informed consent

Exclusion criteria

• active acute cholecystitis
• previous open upper abdominal surgery
• bleeding disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

SILC

Experimental group

Description:

Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision

Treatment:

Procedure: SILC

LC

Active Comparator group

Description:

Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank

Treatment:

Procedure: LC