Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

Not Applicable

Terminated

Conditions: Laparoscopic Donor Nephrectomy

Interventions: Device: Percuvance™ Percutaneous Surgical System

Registration Number: NCT02805517

Lead Sponsor: Loma Linda University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

Inclusion Criteria

Patients undergoing laparoscopic donor nephrectomy

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 laparoscopic nephrectomy	Percuvance™ Percutaneous Surgical System	Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.

Primary Outcome Measures

Name	Time	Method
Time to First Opioid Use	up to 1 day postoperatively	Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type.
Total Inpatient Opioid Dosage	3 days postoperatively	Total opioid dosage administered throughout the patient's inpatient stay. Measured in units of Morphine Milligram Equivalents (MME).
Pain Score of All Surgical Sites	up to 2 days postoperatively	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.

Secondary Outcome Measures

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