Clinical trial NCT01397565: Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy
Official title: Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholelithiasis
Cholecystectomy
Keywords: Cholecystectomy
Laparoscopy
Minilaparoscopic surgery
Post-operative pain
Recovery time
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background Since its introduction in the late 1980's, laparoscopic cholecystectomy has quickly become the standard of care in surgery for benign disease of the gallbladder. When compared to open surgery, laparoscopic surgery is associated with decreased post-operative pain. Recovery time and return to usual activity are also significantly shorter following the laparoscopic procedure. Cholecystectomy in the era of laparoscopic surgery has become an out-patient procedure. Furthermore, laparoscopic surgery eliminates a large surgical scar and provides patients an improved cosmetic result .

Laparoscopic technology has evolved rapidly over the last 20 years. The quality of instruments, and especially of optics, has greatly improved since the first laparoscopic cholecystectomies were performed. A significant trend in the development of new technologies has been the move toward smaller instruments and cameras. Where 10mm cameras were standard in the early years of laparoscopy, 5mm cameras now offer excellent optical quality and permit the use of fewer 10mm trocars. In this movement toward increasingly less invasive techniques, minilaparoscopic surgery has emerged. Minilaparoscopic surgery (also called needlescopic surgery) involves the use of smaller trocars and instruments, typically 3mm in size. It is hypothesized that smaller trocars cause less tissue damage and therefore result in improved post-operative pain and recovery, while offering the additional benefit of improved cosmesis.

Previous studies have found minilaparoscopic surgery to be safe, with complication rates no greater than those of conventional laparoscopic technique. In some studies, minilaparoscopic cholecystectomy has been associated with slightly increased operative time. Previous studies have also noted higher conversion rates (a change in the planned operative technique to another technique), however this conversion is typically from minilaparoscopy to conventional laparoscopy; the rate of conversion from minilaparoscopy to an open procedure is no higher than with conventional laparoscopy. However a recent meta-analysis performed by Thakur et al. (1) found that while some studies have shown these trends toward longer operative times and increased conversion rates, the overall evidence for this is weak.

While a number of previous studies have attempted evaluate the benefits that patients derive from minilaparoscopic surgery, including post-operative pain and recovery time, many of these studies have been flawed by methodological concerns. Thakur et al showed in their meta-analysis that minilaparoscopic cholecystectomy was associated with improved cosmesis at one month as well as reduced post-operative pain and faster recovery time. These benefits however were estimated to be minimal based on the available evidence. Unclear reporting of trials and flawed study design, specifically the lack of "intention to treat" analysis, make the interpretation of available data difficult and the meta-analysis concluded that "the evidence for using minicholecystecomy is unclear."

More high quality evidence is needed for the surgical community to determine the utility and benefits of minilaparoscopic cholecystectomy. It is our hope that through a rigorous methodological design we can add to the available literature and determine if minilaparoscopic cholecystectomy is a valuable technique that will benefit patients.

Hypothesis Minilaparoscopic surgery will reduce postoperative pain and recovery time, as well as improve cosmetic results in patients undergoing cholecystectomy.

Objectives

A randomized trial comparing minilaparoscopic cholecystectomy to standard laparoscopic cholecystectomy will be performed to:

1. Determine if minilaparoscopic surgery is associated with decreased postoperative pain
2. Determine if minilaparoscopic surgery results is associated with quicker recovery and return to usual activities
3. Determine if minilaparoscopic surgery is associated with in an improved cosmetic result

Eligibility 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

Primary outcomes:
measure: Post-operative pain
timeFrame: First seven days post-op, 3 weeks post-op
measure: Time to recovery
timeFrame: 3 weeks post-operatively
measure: Cosmetic result
timeFrame: 3 months post-operatively
Secondary outcomes:
measure: Operative complications
timeFrame: First 3 months post-op
measure: Operative technique
timeFrame: Recorded at visit 3 weeks post-op
measure: Length of operation
timeFrame: Recorded at visit 3 weeks post-op
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Liane Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.