Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02811601

Enrollment

Registered

2016-06-23

Start date

2016-06-30

Completion date

2022-05-13

Last updated

2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic Diseases

Keywords

Minimally Invasive Surgical Procedures

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREPEAL 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing laparoscopic urologic surgery

Exclusion criteria

* Patients unwilling to participate in the study * Patients unfit for laparoscopic surgery

Design outcomes

Primary

Measure	Time frame
Time to first opioid use	up to 30 days postoperatively
Total inpatient opioid dosage	up to 30 days postoperatively
Pain score of all surgical sites	up to 3 days postoperatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026