Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy - Full Text View

Purpose

Laparoscopic cholecystectomy is one of the most commonly performed operations in general surgery and is considered the standard of care for cholecystectomy for benign biliary disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is associated with less postoperative pain, quicker recovery time and an improved cosmetic result.

Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further reduce postoperative pain and recovery time as well as improve cosmetic results following laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing conventional to minilaparoscopic cholecystectomy.

Condition	Intervention	Phase
Cholelithiasis Cholecystectomy	Procedure: Laparoscopic cholecystectomy Procedure: Minilaparoscopic cholecystectomy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics Gallstones

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

Post-operative pain [ Time Frame: First seven days post-op, 3 weeks post-op ] [ Designated as safety issue: No ]
Post-operative pain will be assessed during the first week post-operatively using a diary that will be provided to patients. In this diary, patients will score their pain daily using a visual analog scale (0=no pain and 10=severe pain) and record use of pain medications for the first seven days post-operatively. Patients will again be asked to score their pain using the visual analog scale at the regularly scheduled follow-up visit three weeks post-op.
Time to recovery [ Time Frame: 3 weeks post-operatively ] [ Designated as safety issue: No ]
Time to recovery (return to baseline level of activity) will be evaluated by comparing baseline physical activity scores to physical activity scores determined at the follow-up visit three weeks post-op. Physical activity scores will be obtained using the validated CHAMPS questionnaire (2)
Cosmetic result [ Time Frame: 3 months post-operatively ] [ Designated as safety issue: No ]
Cosmetic result will be evaluated using a scar assessment questionnaire (3), that will be administered by the study coordinator at the routine post-op visit as well as at three months by telephone

Secondary Outcome Measures:

Operative complications [ Time Frame: First 3 months post-op ] [ Designated as safety issue: Yes ]
Intra-operative, in-hospital (if applicable) and postoperative complications will be recorded and graded according to the Clavien Classification. Superficial and deep incisional surgical site infections will be defined according to the CDC definition.
Operative technique [ Time Frame: Recorded at visit 3 weeks post-op ] [ Designated as safety issue: Yes ]
Conversion to conventional laparoscopic technique or open procedure will be recorded at the time of operation.
Length of operation [ Time Frame: Recorded at visit 3 weeks post-op ] [ Designated as safety issue: Yes ]
The time necessary to complete the intervention will be recorded

Estimated Enrollment:	115
Study Start Date:	February 2012
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Laparoscopic cholecystectomy Patients in this arm will undergo conventional laparoscopic cholecystectomy	Procedure: Laparoscopic cholecystectomy Laparoscopic cholecystectomy
Experimental: Minilaparoscopic cholecystectomy Patients in this arm will undergo laparoscopic cholecystectomy using minilaparoscopic instruments	Procedure: Minilaparoscopic cholecystectomy Laparoscopic cholecystectomy performed using minilaparoscopic instruments Other Name: Needlescopic surgery

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

minimum 18 years of age
referred for elective cholecystectomy for benign biliary stone disease

Exclusion Criteria:

previous upper gastrointestinal surgery
acute cholecystitis (past or present)
American Society of Anesthesiologists (ASA) class greater than or equal to 4
pregnancy
morbid obesity (BMI > 35 kg/m2)
inability to comprehend questionnaires in either English or French
psychiatric conditions that preclude cooperation and/or comprehension of questionnaires

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397565

Contacts

Contact: Pepa Kaneva, MSc

514-934-1934 ext 42745

pepakk@yahoo.com

Locations

Canada, Quebec
Montreal General Hospital	Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Liane Feldman, MD 514 934-1934 ext 44004 liane.feldman@mcgill.ca
Principal Investigator: Liane Feldman, MD
Sub-Investigator: Gerald Fried, MD
Sub-Investigator: Melina Vassiliou, MD

Sponsors and Collaborators

McGill University Health Center

Investigators

Principal Investigator:

Liane Feldman, MD

McGill University Health Center

More Information

Publications:

Thakur V, Schlachta CM, Jayaraman S. Minilaparoscopic versus conventional laparoscopic cholecystectomy a systematic review and meta-analysis. Ann Surg. 2011 Feb;253(2):244-58. Review.

Feldman LS, Kaneva P, Demyttenaere S, Carli F, Fried GM, Mayo NE. Validation of a physical activity questionnaire (CHAMPS) as an indicator of postoperative recovery after laparoscopic cholecystectomy. Surgery. 2009 Jul;146(1):31-9.

Durani P, McGrouther DA, Ferguson MW. The Patient Scar Assessment Questionnaire: a reliable and valid patient-reported outcomes measure for linear scars. Plast Reconstr Surg. 2009 May;123(5):1481-9.

Responsible Party:	Dr. Liane S. Feldman, MD, McGill University Health Center
ClinicalTrials.gov Identifier:	NCT01397565 History of Changes
Other Study ID Numbers:	11-053-SDR
Study First Received:	July 5, 2011
Last Updated:	April 19, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

Cholecystectomy
Laparoscopy
Minilaparoscopic surgery
Post-operative pain
Recovery time

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 16, 2013