Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

NCT01873638

Gallstone Disease

COMPLETED NA

A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy

NCT01094379

Cholecystectomy, Laparoscopic

UNKNOWN NA

A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

NCT01489436

CHOLELITHIASIS

COMPLETED NA

Conventional Versus Modified Laparoscopic Cholecystectomy

NCT01312025

Laparoscopic Cholecystectomy

COMPLETED NA

Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy

NCT03160157

Gallbladder Diseases

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholelithiasis Cholecystectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic cholecystectomy

Patients in this arm will undergo conventional laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Minilaparoscopic cholecystectomy

Patients in this arm will undergo laparoscopic cholecystectomy using minilaparoscopic instruments

Group Type EXPERIMENTAL

Minilaparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy performed using minilaparoscopic instruments

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Minilaparoscopic cholecystectomy

Laparoscopic cholecystectomy performed using minilaparoscopic instruments

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Needlescopic surgery

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No