Multi-Port Versus Single-port Cholecystectomy

Summary

The aim of this study is to compare results of the new surgical strategy to the traditional 4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular we are going to investigate the procedures in terms of overall morbidity, while taking into considerations skin-incision's related morbidity, postoperative pain and cosmetic results which are the hypothetical benefits of the new approach. Other parameters are supposed to be unchanged, considering evidences from recent literature.

Surgical procedures:

4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique.

Single Port Access cholecystectomy (SPC): the single-port device is inserted through the umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the fundus to retract it.

Primary endpoint: overall morbidity rate (at 60 days from surgery)

Secondary endpoints:

1. skin-incision's related morbidity rate (at 60 days from surgery)
2. perioperative pain
3. cosmetic results
4. long-term morbidity (12 months)
5. intraoperative time
6. "conversion SPC to 4PC" rate
7. "conversion to laparotomy" rate
8. hospital stay

Conditions

• Cholelithiasis

Interventions

PROCEDURE

4-Ports Cholecystectomy (4PC)

a 12mmHg pneumoperitoeum is created either by a 10mm umbelical Hasson's port or by a Verress needle followed by a 10 mm umbelical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique. A straight or angulated laparoscope may be used. Laparoscopic graspers, monopolar hook, bipolar forceps, scissors and 10mm clips-applier are used. A plastic bag system might be used for gall bladder extraction if necessary. In both 10 and 12mm accesses, fascia is sutured with resorbable sutures. Skin is secured by either metallic agraffes or interrupted sutures.

PROCEDURE

Single-Port Cholecystectomy (SPC)

a 2.5cm long skin incision around the umbilicus is performed. The subcutaneous tissue is dissected, the muscular fascia exposed and incised along the middle line (linea alba) respecting the muscular tissue. Peritoneum is identified and incised. The Single-Port device is inserted and anchored. In order to retract the gallbladder a transcutaneous suture is placed in the right hypocondrium with a straight needle and a monofilament thread which are passed through the fundus and knotted outside the skin. The following steps reproduce the traditional laparoscopic cholecystectomy. Each centre will be left free to use dedicated instruments and which or traditional laparoscopic ones.

Sponsors & Collaborators

• European Association for Endoscopic Surgery

  lead OTHER

Principal Investigators

• Alberto Arezzo, MD · European Association for Endoscopic Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• Italy

Study Locations