Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Unknown

Conditions: Postoperative Pain

Treatments: Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa); Procedure: Four port laparoscopic cholecystectomy surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01348620

MNT-2011

Details and patient eligibility

About

This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Full description

The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures.

Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies.

The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biliary cholic
• Biliary dyskinesia
• Gallbladder polyps
• Other diagnosis at the discretion of the surgeon

Exclusion criteria

• History of Acute cholecystitis
• Jaundice
• Choledocolithiasis
• History of Pancreatitis
• Severe comorbidity
• BMI > 30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Single port laparoscopic device

Experimental group

Treatment:

Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)

Four-port laparoscopic device

Active Comparator group

Treatment:

Procedure: Four port laparoscopic cholecystectomy surgery