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
|Condition or disease||Intervention/treatment||Phase|
|Laparoscopic Donor Nephrectomy||Device: Percuvance™ Percutaneous Surgical System||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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 ]
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
|Contact: Mohamed Keheila, MD||909 558 4196 ext email@example.com|
|United States, California|
|Loma Linda Medical Center||Recruiting|
|Loma Linda, California, United States, 92350|
|Contact: Mohamed Keheila|
|Study Director:||Mohamed Keheila, MD||Loma Linda University Medical Center|