Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy

NCT01397565 | Completed Phase 4

• 1 other identifier: 11-053-SDR
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis; Cholecystectomy

Keywords

Cholecystectomy; Laparoscopy; Minilaparoscopic surgery; Post-operative pain; Recovery time

Outcome Measures

Primary Outcomes (3)

• Post-operative pain

  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.

  First seven days post-op, 3 weeks post-op

• Time to recovery

  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 weeks post-operatively

• Cosmetic result

  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

  3 months post-operatively

Secondary Outcomes (3)

• Operative complications

  First 3 months post-op

• Operative technique

  Recorded at visit 3 weeks post-op

• Length of operation

  Recorded at visit 3 weeks post-op

Study Arms (2)

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

Patients in this arm will undergo conventional laparoscopic cholecystectomy

Procedure: Laparoscopic cholecystectomy

Minilaparoscopic cholecystectomy

EXPERIMENTAL

Patients in this arm will undergo laparoscopic cholecystectomy using minilaparoscopic instruments

Procedure: Minilaparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Minilaparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy performed using minilaparoscopic instruments

Also known as: Needlescopic surgery

Minilaparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (4)

• 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. doi: 10.1097/SLA.0b013e318207bf52.

  PMID: 21183848 BACKGROUND

• 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. doi: 10.1016/j.surg.2009.02.019.

  PMID: 19541008 BACKGROUND

• 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):1481-1489. doi: 10.1097/PRS.0b013e3181a205de.

  PMID: 19407619 BACKGROUND

• Alhashemi M, Almahroos M, Fiore JF Jr, Kaneva P, Gutierrez JM, Neville A, Vassiliou MC, Fried GM, Feldman LS. Impact of miniport laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy on recovery of physical activity: a randomized trial. Surg Endosc. 2017 May;31(5):2299-2309. doi: 10.1007/s00464-016-5232-z. Epub 2016 Sep 21.

  PMID: 27655375 DERIVED

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Liane Feldman, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 19, 2011
• Study Start: February 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

CA (1)