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Multi-Port Versus Single-port Cholecystectomy (MUSIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by European Association for Endoscopic Surgery
Sponsor:
Information provided by (Responsible Party):
Alberto Arezzo, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier:
NCT01104727
First received: April 14, 2010
Last updated: April 26, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention Phase
Cholelithiasis
Procedure: 4-Ports Cholecystectomy (4PC)
Procedure: Single-Port Cholecystectomy (SPC)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Port vs. Single-port Cholecystectomy

Resource links provided by NLM:


Further study details as provided by European Association for Endoscopic Surgery:

Primary Outcome Measures:
  • overall morbidity rate (at 60 days from surgery) [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    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)]


Secondary Outcome Measures:
  • Skin-incision related morbidity [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    defined as bleeding, infection, necrosis, skin retraction, incisional hernia, suture dehiscence within 60 days from surgery.

  • Postoperative pain [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    defined as a subjective evaluation of the same parameter using an horizontal visual analogical scale daily for the first week and weekly till 60 days after surgery. Patients will be administered Paracetamol IV 3 times a day for the first 24h, than on demand. Tramadol will be administered when Paracetamol will not be judged sufficient for pain control. On request, a single-dose of Ketorolac can be prescribed.

  • Cosmetic results [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    • three independent surgeons: using a standardized methodology. A Likert scale will be used independently by the three surgeons to score the photographs from 1 to 5 (1= very poor, 2= poor, 3= satisfactory, 4= good, 5= very good) in all cases. The mean value will be considered objective evaluation of cosmetic outcome.
    • the patient him/her self: the patient will be asked to score his/her subjective perception of cosmetic outcome using the same Likert scale 60 days from surgery.


Estimated Enrollment: 600
Study Start Date: April 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multi port
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)
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.
Active Comparator: Single port

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)

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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cholecystitis
  • suspected presence of common duct stones
  • suspected presence of biliary cancer
  • Previous abdominal surgery
  • Previous umbilical surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104727

Contacts
Contact: Alberto Arezzo, MD +393358378243 alberto.arezzo@mac.com
Contact: Nicola Di Lorenzo, MD nicola@dilorenzo.it

Locations
Italy
University of Turin Recruiting
Torino, Italy, 10126
Contact: Alberto Arezzo, MD    +393358378243    alberto.arezzo@unito.it   
Principal Investigator: Alberto Arezzo, MD         
Sponsors and Collaborators
European Association for Endoscopic Surgery
Investigators
Study Director: Alberto Arezzo, MD European Association for Endoscopic Surgery
  More Information

No publications provided by European Association for Endoscopic Surgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alberto Arezzo, Assistant Professor of Surgery, European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier: NCT01104727     History of Changes
Other Study ID Numbers: EAES-3
Study First Received: April 14, 2010
Last Updated: April 26, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by European Association for Endoscopic Surgery:
SINGLE PORT SURGERY
LAPAROSCOPY, CHOLECYSTECTOMY

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014