Clinical trial NCT02805517: Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
Official title: A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laparoscopic Donor Nephrectomy
Keywords: Minimally Invasive Surgical Procedures
Transplant Donors
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

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

Primary outcomes:
measure: Time to First Opioid Use
timeFrame: up to 1 day postoperatively
measure: Total Inpatient Opioid Dosage
timeFrame: 3 days postoperatively
measure: Pain Score of All Surgical Sites
timeFrame: up to 2 days postoperatively
Secondary outcomes:
measure: Post-operative Ileus
timeFrame: up to 3 days post-operatively
measure: Time to Ambulation
timeFrame: 3 days post-operatively
measure: Length of Hospital Stay
timeFrame: up do 4 days post-operatively
measure: Presence of Intraoperative Complications
timeFrame: Intraoperatively
measure: Length of Operative Time
timeFrame: Intraoperatively (up to 6 hours)
measure: Estimated Intraoperative Blood Loss
timeFrame: Intraoperatively (up to 6 hours)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Mohamed Keheila, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.