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Clinical Trials/NCT02811601
NCT02811601
Completed
Not Applicable

A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

Loma Linda University1 site in 1 country9 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urologic Diseases
Sponsor
Loma Linda University
Enrollment
9
Locations
1
Primary Endpoint
Time to first opioid use
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This will be a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars.

Detailed Description

The investigators have previously published a study regarding the use of a new surgical paradigm (percutaneous externally assembled laparoscopy, or PEAL) in porcine and cadaveric models in order to allow laparoscopic surgery to take place with improved cosmesis and decreased pain while still allowing the use of larger instruments and maintaining instrument triangulation. The investigators now seek to study the use of these instruments in the human patients undergoing laparoscopic urologic surgery. This will be a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic urologic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars. Multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
May 13, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing laparoscopic urologic surgery

Exclusion Criteria

  • Patients unwilling to participate in the study
  • Patients unfit for laparoscopic surgery

Outcomes

Primary Outcomes

Time to first opioid use

Time Frame: up to 30 days postoperatively

Pain score of all surgical sites

Time Frame: up to 3 days postoperatively

Total inpatient opioid dosage

Time Frame: up to 30 days postoperatively

Study Sites (1)

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