Back to resultsPercutaneous Externally-Assembled Laparoscopic Urologic Surgery
Primary Purpose
Urologic Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEAL surgery
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Diseases focused on measuring Minimally Invasive Surgical Procedures
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing laparoscopic urologic surgery
Exclusion Criteria:
- Patients unwilling to participate in the study
- Patients unfit for laparoscopic surgery
Sites / Locations
- Loma Linda Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEAL surgery
Arm Description
Patients will undergo percutaneous externally-assembled laparoscopic surgery
Outcomes
Primary Outcome Measures
Time to first opioid use
Total inpatient opioid dosage
Pain score of all surgical sites
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02811601
Brief Title
Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
Official Title
A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
Keywords
Minimally Invasive Surgical Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEAL surgery
Arm Type
Experimental
Arm Description
Patients will undergo percutaneous externally-assembled laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
PEAL surgery
Other Intervention Name(s)
PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to first opioid use
Time Frame
up to 30 days postoperatively
Title
Total inpatient opioid dosage
Time Frame
up to 30 days postoperatively
Title
Pain score of all surgical sites
Time Frame
up to 3 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing laparoscopic urologic surgery
Exclusion Criteria:
Patients unwilling to participate in the study
Patients unfit for laparoscopic surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Keheila, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26732739
Citation
Arenas JL, Alsyouf M, Jang M, Myklak K, Faaborg D, Khater N, Baldwin DD. Percutaneous Externally Assembled Laparoscopic Instruments: Creation of a New Surgical Paradigm. J Endourol. 2016 Apr;30(4):433-40. doi: 10.1089/end.2015.0240. Epub 2016 Feb 9.
Results Reference
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PubMed Identifier
26386388
Citation
Rossitto C, Gueli Alletti S, Costantini B, Fanfani F, Scambia G. Total Laparoscopic Hysterectomy With Percutaneous (Percuvance) Instruments: New Frontier of Minimally Invasive Gynecological Surgery. J Minim Invasive Gynecol. 2016 Jan;23(1):14-5. doi: 10.1016/j.jmig.2015.09.004. Epub 2015 Sep 18.
Results Reference
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PubMed Identifier
26618278
Citation
Chang J, Boules M, Rodriguez J, Kroh M. Minilaparoscopy with Interchangeable, Full 5-mm End Effectors: First Human Use of a New Minimally Invasive Operating Platform. J Laparoendosc Adv Surg Tech A. 2016 Jan;26(1):1-5. doi: 10.1089/lap.2015.0418. Epub 2015 Nov 30.
Results Reference
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Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
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