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