Multi-Port Versus Single-port Cholecystectomy

NCT01104727 | Completed Phase 4 DMC

• 1 other identifier: EAES-3
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Cholelithiasis

Keywords

SINGLE PORT SURGERY; LAPAROSCOPY, CHOLECYSTECTOMY

Outcome Measures

Primary Outcomes (1)

• overall morbidity rate (at 60 days from surgery)

  Morbidity, defined as the occurrence of any complication, directly or indirectly related to surgery. Complications will be classified according to Dindo \[Dindo D., Demartines N., Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13)\]

  60 days

Secondary Outcomes (3)

• Skin-incision related morbidity

  60 days

• Postoperative pain

  60 days

• Cosmetic results

  60 days

Study Arms (2)

Multi port

ACTIVE COMPARATOR

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: 4-Ports Cholecystectomy (4PC)

Single port

ACTIVE COMPARATOR

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.

Procedure: Single-Port Cholecystectomy (SPC)

Interventions

4-Ports Cholecystectomy (4PC) PROCEDURE

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.

Multi port

Single-Port Cholecystectomy (SPC) PROCEDURE

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.

Single port

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: 18-75
• BMI: \<30
• ASA: I-III
• absence of non-correctable coagulopathy (international normalized ratio \>1,5, or platelet count \<90 × 109/l).
• diagnosis: cholelithiasis (gallstones \< 2 cm in diameter) gallbladder dyskinesia

You may not qualify if:

• cholecystitis
• suspected presence of common duct stones
• suspected presence of biliary cancer
• Previous abdominal surgery
• Previous umbilical surgery

Sponsors & Collaborators

• European Association for Endoscopic Surgery: lead

Study Sites (1)

University of Turin

Torino, 10126, Italy

Location

Related Publications (3)

• Arezzo A, Passera R, Bullano A, Mintz Y, Kedar A, Boni L, Cassinotti E, Rosati R, Fumagalli Romario U, Sorrentino M, Brizzolari M, Di Lorenzo N, Gaspari AL, Andreone D, De Stefani E, Navarra G, Lazzara S, Degiuli M, Shishin K, Khatkov I, Kazakov I, Schrittwieser R, Carus T, Corradi A, Sitzman G, Lacy A, Uranues S, Szold A, Morino M. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial). Surg Endosc. 2017 Jul;31(7):2872-2880. doi: 10.1007/s00464-016-5298-7. Epub 2016 Oct 24.

  PMID: 27778171 DERIVED

• Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.

  PMID: 21910897 DERIVED

• Arezzo A, Morino M. Endoscopic surgery through single-port incision: time for a trial? Surg Endosc. 2011 Jun;25(6):1709-11. doi: 10.1007/s00464-011-1679-0. No abstract available.

  PMID: 21553174 DERIVED

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Alberto Arezzo, MD

  European Association for Endoscopic Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

IT (1)