Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

Laparoscopic Donor Nephrectomy Clinical Trial

Official title:

A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02805517
• Other study ID #: 5160152
• Status: Terminated
• Phase: N/A
• Start date: July 11, 2016
• Est. completion date: May 26, 2021

Study information

• Verified date: November 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

• Patients unwilling to participate in the study

• Patients unfit for laparoscopic surgery

Related Conditions & MeSH terms

• Laparoscopic Donor Nephrectomy

Intervention

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 12 mm trocars.

Locations

Country	Name	City	State
United States	Loma Linda Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Post-operative Ileus	Duration of post-operative ileus as measured by days until return of normal bowel function was noted.	up to 3 days post-operatively
Secondary	Time to Ambulation	Number of post-operative days before patient was noted to be ambulating.	3 days post-operatively
Secondary	Length of Hospital Stay	Number of days admitted to the hospital from surgery until hospital discharge	up do 4 days post-operatively
Secondary	Presence of Intraoperative Complications	The number of patients with an intraoperative complication.	Intraoperatively
Secondary	Length of Operative Time	Duration of surgical operation from incision time to procedure stop time	Intraoperatively (up to 6 hours)
Secondary	Estimated Intraoperative Blood Loss	Estimated Blood Loss during the nephrectomy procedure	Intraoperatively (up to 6 hours)