A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal (CENoMIP)

Mayo Clinic

Status: Completed

Conditions: CHOLELITHIASIS

Treatments: Procedure: Four-port laparoscopic cholecystectomy; Procedure: Single-port cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01489436

11-001162

Details and patient eligibility

About

New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

Full description

To establish a pathway for comparative effectiveness using patient reported outcomes in minimally invasive surgery, we propose to use a readily available and easily reproducible model: cholecystectomy. Each year in the United States, approximately 750,000 patients undergo a cholecystectomy. Patients clearly prefer the laparoscopic approach over the open procedure to abdominal surgery. Initial survey data suggest that patients may also prefer even less invasive approaches.

Currently, the standard operative procedure for a patient with symptomatic gallstone disease is a laparoscopic cholecystectomy performed under general anesthesia with four small abdominal incisions. Although postoperative pain and cardiopulmonary and wound complications are much less compared to open cholecystectomy, considerable cost is generated from lost productivity in days off of work after the surgical procedure related in part to pain and the physiologic response to the stress of the operative procedure. Anecdotal data suggest that fewer incisions, especially fewer transabdominal incisions, translate into less pain, less need for narcotic pain medication and faster recovery, but randomized trial data are needed. We propose to compare the effectiveness of the novel single-port cholecystectomy with laparoscopic cholecystectomy, the current standard of care.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for this study are:

1. patients undergoing cholecystectomy in an elective setting for symptomatic gallstone disease.

Exclusion criteria for the study are:

1. Patients <18 years of age
2. Pregnant patients
3. Patients with ASA-class >3
4. Patients undergoing treatment for chronic pain with opiates
5. Patients with biopsy proven gallbladder cancer
6. Patients who cannot provide consent for the study
7. Patients not willing to participate in the study
8. Prisoners/Institutionalized individuals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 2 patient groups

Single port cholecystectomy

Active Comparator group

Description:

In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary; this device is placed percutaneously without the need for a trocar. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port, adequate hemostasis is ensured, the umbilical trocar removed, and the single operative site will be closed and sterile dressings applied (four Band-Aids).

Treatment:

Procedure: Single-port cholecystectomy

Four-port laparoscopic cholecystectomy

Active Comparator group

Description:

The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder. Trocar sites will be closed and sterile dressings applied (four Band-Aids).

Treatment:

Procedure: Four-port laparoscopic cholecystectomy