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Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

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ClinicalTrials.gov Identifier: NCT02805517
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
D. Duane Baldwin, Loma Linda University

Study Description
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Brief Summary:
This will be a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy 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

Condition or disease Intervention/treatment Phase
Laparoscopic Donor Nephrectomy Device: Percuvance™ Percutaneous Surgical System Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
Study Start Date : August 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023
Arms and Interventions
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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 10 mm trocars.
Other Name: PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL)


Outcome Measures
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Primary Outcome Measures :
  1. Time to first opioid use [ Time Frame: up to 30 days postoperatively ]
  2. Total inpatient opioid dosage [ Time Frame: 30 days postoperatively ]
  3. Pain score of all surgical sites [ Time Frame: up to 3 days postoperatively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

  • Patients unwilling to participate in the study
  • Patients unfit for laparoscopic surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805517


Contacts
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Contact: Mohamed Keheila, MD 909 558 4196 ext 44196 mkeheila@llu.edu

Locations
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United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Mohamed Keheila         
Sponsors and Collaborators
Loma Linda University
Investigators
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Study Director: Mohamed Keheila, MD Loma Linda University Medical Center
More Information
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Publications:

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Responsible Party: D. Duane Baldwin, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT02805517    
Other Study ID Numbers: 5160152
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by D. Duane Baldwin, Loma Linda University:
Minimally Invasive Surgical Procedures
Transplant Donors