Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | June 2016 |
| End Date: | June 2020 |
| Contact: | Mohamed Keheila, MD |
| Email: | mkeheila@llu.edu |
| Phone: | 909 558 4196 |
A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
This will be a single-arm prospective internally-controlled study. Patients will undergo
percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are
added or substituted for conventional 5 or 10 mm trocars.
percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are
added or substituted for conventional 5 or 10 mm trocars.
The investigators 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. The investigators now seek to study the use of these instruments in the human
patients undergoing laparoscopic urologic surgery.
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.
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. The investigators now seek to study the use of these instruments in the human
patients undergoing laparoscopic urologic surgery.
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 urologic surgery
Exclusion Criteria:
- Patients unwilling to participate in the study
- Patients unfit for laparoscopic surgery
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