Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

Study Overview
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Brief Summary
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A single-arm prospective internally-controlled study. Patients will undergo Percutaneous Externally-Assembled Laparoscopic (PEAL) donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 12 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

Detailed Description
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Purpose: Prior investigators have created methods to perform laparoscopic surgeries using smaller instruments and ports in an attempt to improve cosmesis and postoperative pain. However, These methods may be limited by the requirement for smaller instruments with decreased functionality or by the loss of instrument triangulation. We 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. We now seek to study the use of these instruments in the human patients undergoing laparoscopic urologic surgery. The procedures include: Hundred subjects will be recruited for the study with an expected attrition rate of 10%. Sample size has been minimized, but is necessary for statistical power and conclusions. Subjects will be male and female 18 years or older, of all ethnicities, denominations or other social/economical variations. All participants will speak English fluently in order for consent to be performed properly. Baseline pain score will be calculated through a questionnaire in at the urology clinic. This is 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 12 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
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A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

Conditions
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Laparoscopic Donor Nephrectomy

Intervention / Treatment
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* Device: Percuvance™ Percutaneous Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic donor nephrectomy Exclusion Criteria: Patients unwilling to participate in the study Patients unfit for laparoscopic surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEAL laparoscopic nephrectomy<br>Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments. | Device: Percuvance™ Percutaneous Surgical System<br>* Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars.<br>* Other names: PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Opioid Use | Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type. | up to 1 day postoperatively | 
| Total Inpatient Opioid Dosage | Total opioid dosage administered throughout the patient's inpatient stay. Measured in units of Morphine Milligram Equivalents (MME). | 3 days postoperatively | 
| Pain Score of All Surgical Sites | A patient-reported pain score (on a scale of 1-10, with 10 being the worst) for each of the four port-site incisions, as measured by the Brief Pain Inventory. Scores were measured on both post-operative day one and on post-operative day two. The four port-site incisions which patients ranked pain scores for were: #1 - Hand-assist Port; #2 - 12 mm Port; #3 - 5 mm Port; #4 - Percutaneous Externally-Assembled Laparoscopic (PEAL) Port. A mean pain score was calculated by averaging the data across the two days. | up to 2 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Ileus | Duration of post-operative ileus as measured by days until return of normal bowel function was noted. | up to 3 days post-operatively | 
| Time to Ambulation | Number of post-operative days before patient was noted to be ambulating. | 3 days post-operatively | 
| Length of Hospital Stay | Number of days admitted to the hospital from surgery until hospital discharge | up do 4 days post-operatively | 
| Presence of Intraoperative Complications | The number of patients with an intraoperative complication. | Intraoperatively | 
| Length of Operative Time | Duration of surgical operation from incision time to procedure stop time | Intraoperatively (up to 6 hours) | 
| Estimated Intraoperative Blood Loss | Estimated Blood Loss during the nephrectomy procedure | Intraoperatively (up to 6 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Surgical Procedures, Transplant Donors