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Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 20, 2016
Last Update Posted Date October 14, 2020
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
  • Time to first opioid use [ Time Frame: up to 30 days postoperatively ]
  • Total inpatient opioid dosage [ Time Frame: 30 days postoperatively ]
  • Pain score of all surgical sites [ Time Frame: up to 3 days postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
Official Title  ICMJE A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Donor Nephrectomy
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: PEAL laparoscopic nephrectomy
Patients will undergo percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Intervention: Device: Percuvance™ Percutaneous Surgical System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2016)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

  • Patients unwilling to participate in the study
  • Patients unfit for laparoscopic surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed Keheila, MD 909 558 4196 ext 44196 mkeheila@llu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02805517
Other Study ID Numbers  ICMJE 5160152
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party D. Duane Baldwin, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohamed Keheila, MD Loma Linda University Medical Center
PRS Account Loma Linda University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP