Loma Linda, California 92350

  • Urologic Diseases

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients undergoing laparoscopic urologic surgery Exclusion Criteria: - Patients unwilling to participate in the study - Patients unfit for laparoscopic surgery


NCT ID:

NCT02811601


Primary Contact:

Study Director
Mohamed Keheila, MD
Loma Linda University Medical Center

Mohamed Keheila, MD
Phone: 909 558 4196 ext. 44196
Email: mkeheila@llu.edu


Backup Contact:

N/A


Location Contact:

Loma Linda, California 92350
United States

Mohamed Keheila

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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