A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

Not Applicable

Completed

• Conditions: CHOLELITHIASIS

• Registration Number: NCT01489436
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States