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

March 15, 2019 updated by: Juliane Bingener-Casey, Mayo Clinic

Comparative Effectiveness of Novel Minimally Invasive Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single port cholecystectomy
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).
Procedure: Single-port cholecystectomy
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. This trocar permits simultaneous introduction of multiple instruments, including a 5-mm flexible-tip laparoscope. Standard 5-mm instruments will be used for retraction and dissection. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary. 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.
Other Names:
  • Minimally invasive surgery
Active Comparator: Four-port laparoscopic cholecystectomy
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).
Procedure: Four-port laparoscopic cholecystectomy
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.
Other Names:
  • Minimally invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: Baseline to Post Operative day 1
The investigators will utilize the Patient-Reported Outcomes from the VAS to measure changes from Baseline to day 1 post OP. A 15-mm difference on a 100-mm visual analog scale with a standard deviation of 25 mm at any time point will constitute a clinically relevant difference.
Baseline to Post Operative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QOL)
Time Frame: up to 7 days

Patients QOL will be measured via Patient-Reported Outcomes Measures Information System (PROMIS) and Linear Analog Self Assessment (LASA) tools.

PROMIS Global Health Short Form and LASA are validated assessment tools. A 2-point difference is considered the minimally important difference in chronic disease for an item in the PROMIS and LASA tools.
up to 7 days
Heart Rate Variability (HRV) Data
Time Frame: During surgery from incision to closure
HRV is the bodies' physiological response to pain as measured through digitally captured ECG combined with electronically captured blood pressure.We will measure HRV to determine subtle differences between to the two surgical approaches.
During surgery from incision to closure
Cytokine levels in blood
Time Frame: Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour post OP
Frequently used biomarkers are inflammatory cytokines, specifically the serum levels of the early response pro-inflammatory cytokines TNF-α, Interleukin 1b, Interleukin 6 and Interleukin 8. We will measure and analyze these cytokine levels at set time points to determine if any subtle difference in the levels between the two surgical approaches is significant.
Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour post OP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Juliane Bingener-Casey, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-001162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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