Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy
Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy
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.
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
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