Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

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

Study Overview

• Status: Terminated
• Conditions: Laparoscopic Donor Nephrectomy
• Intervention / Treatment: Device: Percuvance™ Percutaneous Surgical System

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEAL laparoscopic nephrectomy; Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.	Device: Percuvance™ Percutaneous Surgical System; 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.; 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	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)

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Study Director: Mohamed Keheila, MD, Loma Linda University Medical Center

Publications and helpful links

General Publications

• Arenas JL, Alsyouf M, Jang M, Myklak K, Faaborg D, Khater N, Baldwin DD. Percutaneous Externally Assembled Laparoscopic Instruments: Creation of a New Surgical Paradigm. J Endourol. 2016 Apr;30(4):433-40. doi: 10.1089/end.2015.0240. Epub 2016 Feb 9.
• Rossitto C, Gueli Alletti S, Costantini B, Fanfani F, Scambia G. Total Laparoscopic Hysterectomy With Percutaneous (Percuvance) Instruments: New Frontier of Minimally Invasive Gynecological Surgery. J Minim Invasive Gynecol. 2016 Jan;23(1):14-5. doi: 10.1016/j.jmig.2015.09.004. Epub 2015 Sep 18.
• Chang J, Boules M, Rodriguez J, Kroh M. Minilaparoscopy with Interchangeable, Full 5-mm End Effectors: First Human Use of a New Minimally Invasive Operating Platform. J Laparoendosc Adv Surg Tech A. 2016 Jan;26(1):1-5. doi: 10.1089/lap.2015.0418. Epub 2015 Nov 30.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2016
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Minimally Invasive Surgical Procedures; Transplant Donors
• Other Study ID Numbers: 5160152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes