Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01397565
First received: July 5, 2011
Last updated: April 19, 2012
Last verified: April 2012
  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:


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

  Show Detailed Description

  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
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: 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:
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 July 24, 2014