Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

Study 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.

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

Conditions
-----------------
Urologic Diseases

Intervention / Treatment
-----------------
* Procedure: PEAL surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing laparoscopic urologic surgery Exclusion Criteria: Patients unwilling to participate in the study Patients unfit for laparoscopic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEAL surgery<br>Patients will undergo percutaneous externally-assembled laparoscopic surgery | Procedure: PEAL surgery<br>* 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.<br>* Other names: PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first opioid use |  | up to 30 days postoperatively | 
| Total inpatient opioid dosage |  | up to 30 days postoperatively | 
| Pain score of all surgical sites |  | up to 3 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimally Invasive Surgical Procedures