An interventional study of PEAL surgery in Urologic Diseases, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
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.
193 studies on the registry are indexed under Urologic Diseases; 51 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 135 interventional studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo percutaneous externally-assembled laparoscopic surgery
Procedure: PEAL surgery
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.
Also known as: PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL)
Time to first opioid use
Time frame: up to 30 days postoperatively
Total inpatient opioid dosage
Time frame: up to 30 days postoperatively
Pain score of all surgical sites
Time frame: up to 3 days postoperatively
Plan to share: Undecided
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Loma Linda University