Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

Not Applicable

Completed

• Conditions: Urologic Diseases
• Interventions: Procedure: PEAL surgery

• Registration Number: NCT02811601
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-23
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients undergoing laparoscopic urologic surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEAL surgery	PEAL surgery	Patients will undergo percutaneous externally-assembled laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
Time to first opioid use	up to 30 days postoperatively
Pain score of all surgical sites	up to 3 days postoperatively
Total inpatient opioid dosage	up to 30 days postoperatively

Trial Locations

Locations (1)

Loma Linda Medical Center; 🇺🇸 Loma Linda, California, United States