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

Primary Purpose

CHOLELITHIASIS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-port cholecystectomy
Four-port laparoscopic cholecystectomy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CHOLELITHIASIS focused on measuring gallstone disease, cholecystectomy, minimally invasive, surgical, laparoscopic, single port, cytokine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single port cholecystectomy

Four-port laparoscopic cholecystectomy

Arm 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).

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).

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analog Scale
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.

Secondary Outcome Measures

Quality of Life (QOL)
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.
Heart Rate Variability (HRV) Data
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.
Cytokine levels in blood
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.

Full Information

First Posted
August 25, 2011
Last Updated
March 15, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01489436
Brief Title
A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal
Acronym
CENoMIP
Official Title
Comparative Effectiveness of Novel Minimally Invasive Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHOLELITHIASIS
Keywords
gallstone disease, cholecystectomy, minimally invasive, surgical, laparoscopic, single port, cytokine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single port cholecystectomy
Arm Type
Active Comparator
Arm 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).
Arm Title
Four-port laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Single-port cholecystectomy
Other Intervention Name(s)
Minimally invasive surgery
Intervention 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. 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.
Intervention Type
Procedure
Intervention Name(s)
Four-port laparoscopic cholecystectomy
Other Intervention Name(s)
Minimally invasive surgery
Intervention 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.
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
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.
Time Frame
Baseline to Post Operative day 1
Secondary Outcome Measure Information:
Title
Quality of Life (QOL)
Description
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.
Time Frame
up to 7 days
Title
Heart Rate Variability (HRV) Data
Description
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.
Time Frame
During surgery from incision to closure
Title
Cytokine levels in blood
Description
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.
Time Frame
Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour post OP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Patients <18 years of age Pregnant patients Patients with ASA-class >3 Patients undergoing treatment for chronic pain with opiates Patients with biopsy proven gallbladder cancer Patients who cannot provide consent for the study Patients not willing to participate in the study Prisoners/Institutionalized individuals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliane Bingener-Casey, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26095558
Citation
Bingener J, Skaran P, McConico A, Novotny P, Wettstein P, Sletten DM, Park M, Low P, Sloan J. A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes. J Am Coll Surg. 2015 Jul;221(1):111-21. doi: 10.1016/j.jamcollsurg.2015.02.022. Epub 2015 Mar 3.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/26095558
Description
A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.
URL
http://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

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