Working... Menu

Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397565
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : September 29, 2015
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Center

Brief Summary:

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 or disease Intervention/treatment Phase
Cholelithiasis Cholecystectomy Procedure: Laparoscopic cholecystectomy Procedure: Minilaparoscopic cholecystectomy Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial
Study Start Date : February 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: First seven days post-op, 3 weeks post-op ]
    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.

  2. Time to recovery [ Time Frame: 3 weeks post-operatively ]
    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)

  3. Cosmetic result [ Time Frame: 3 months post-operatively ]
    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 :
  1. Operative complications [ Time Frame: First 3 months post-op ]
    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.

  2. Operative technique [ Time Frame: Recorded at visit 3 weeks post-op ]
    Conversion to conventional laparoscopic technique or open procedure will be recorded at the time of operation.

  3. Length of operation [ Time Frame: Recorded at visit 3 weeks post-op ]
    The time necessary to complete the intervention will be recorded

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397565

Layout table for location information
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
Layout table for investigator information
Principal Investigator: Liane Feldman, MD McGill University Health Center

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Liane S. Feldman, MD, McGill University Health Center Identifier: NCT01397565     History of Changes
Other Study ID Numbers: 11-053-SDR
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Dr. Liane S. Feldman, McGill University Health Center:
Minilaparoscopic surgery
Post-operative pain
Recovery time

Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical