Multi-Port Versus Single-port Cholecystectomy (MUSIC)
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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:
- skin-incision's related morbidity rate (at 60 days from surgery)
- perioperative pain
- cosmetic results
- long-term morbidity (12 months)
- intraoperative time
- "conversion SPC to 4PC" rate
- "conversion to laparotomy" rate
- 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 |
- 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)]
- 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 2012 |
| Estimated Primary Completion Date: | July 2012 (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 |
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| Contact: Alberto Arezzo, MD | +393358378243 | alberto.arezzo@mac.com |
| Contact: Nicola Di Lorenzo, MD | nicola@dilorenzo.it |
| Italy | |
| University of Turin | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Alberto Arezzo, MD +393358378243 alberto.arezzo@unito.it | |
| Principal Investigator: Alberto Arezzo, MD | |
| 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, University of Torino, Italy |
| ClinicalTrials.gov Identifier: | NCT01104727 History of Changes |
| Other Study ID Numbers: | EAES-3 |
| Study First Received: | April 14, 2010 |
| Last Updated: | December 30, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Italy: Ministry of Health |
Keywords provided by European Association for Endoscopic Surgery:
|
SINGLE PORT SURGERY LAPAROSCOPY, CHOLECYSTECTOMY |
Additional relevant MeSH terms:
|
Cholelithiasis Cholecystolithiasis Gallstones Biliary Tract Diseases |
Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013