Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

NCT02805517 | Terminated Results FDA Device

• 1 other identifier: 5160152
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic Donor Nephrectomy

Keywords

Minimally Invasive Surgical Procedures; Transplant Donors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Post-operative Ileus

  up to 3 days post-operatively

• Time to Ambulation

  3 days post-operatively

• Length of Hospital Stay

  up do 4 days post-operatively

• Presence of Intraoperative Complications

  Intraoperatively

• Length of Operative Time

  Intraoperatively (up to 6 hours)

Study Arms (1)

PEAL laparoscopic nephrectomy

EXPERIMENTAL

Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.

Device: Percuvance™ Percutaneous Surgical System

Interventions

Percuvance™ Percutaneous Surgical System DEVICE

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.

Also known as: PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL)

PEAL laparoscopic nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparoscopic donor nephrectomy

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Medical Center

Loma Linda, California, 92350, United States

Location

Related Publications (3)

• 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.

  PMID: 26732739 BACKGROUND

• 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.

  PMID: 26386388 BACKGROUND

• 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.

  PMID: 26618278 BACKGROUND

Limitations and Caveats

Although this was a prospective single-blinded study, it was limited by a modest sample size as the performance of donor nephrectomy surgeries transitioned to a separate surgical department not participating in this study.

Results Point of Contact

• Title: Dr. Duane Baldwin
• Organization: Loma Linda University Health

dbaldwin@llu.edu

909-588-4000

Study Officials

• Mohamed Keheila, MD

  Loma Linda University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 20, 2016
• Study Start: July 11, 2016
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: December 13, 2022
• Results First Posted: December 13, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)