Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy

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.

Inclusion Criteria:

- Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

- Patients unwilling to participate in the study

- Patients unfit for laparoscopic surgery