Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT01397565|
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : September 29, 2015
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Active Comparator: Laparoscopic cholecystectomy
Patients in this arm will undergo conventional laparoscopic cholecystectomy
Procedure: 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
- 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.
- 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)
- 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
- 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.
- 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.
- Length of operation [ Time Frame: Recorded at visit 3 weeks post-op ]The time necessary to complete the intervention will be recorded
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 ClinicalTrials.gov identifier (NCT number): NCT01397565
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Liane Feldman, MD||McGill University Health Center|