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Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

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ClinicalTrials.gov Identifier: NCT02811601
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
D. Duane Baldwin, Loma Linda University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urologic Diseases Procedure: PEAL surgery Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
Study Start Date : June 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: PEAL surgery
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.
Other Name: PERCUTANEOUS EXTERNALLY-ASSEMBLED LAPAROSCOPIC (PEAL)


Outcome Measures
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Primary Outcome Measures :
  1. Time to first opioid use [ Time Frame: up to 30 days postoperatively ]
  2. Total inpatient opioid dosage [ Time Frame: up to 30 days postoperatively ]
  3. Pain score of all surgical sites [ Time Frame: up to 3 days postoperatively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing laparoscopic urologic surgery

Exclusion Criteria:

  • Patients unwilling to participate in the study
  • Patients unfit for laparoscopic surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811601


Contacts
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Contact: Mohamed Keheila, MD 909 558 4196 ext 44196 mkeheila@llu.edu

Locations
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United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Mohamed Keheila         
Sponsors and Collaborators
Loma Linda University
Investigators
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Study Director: Mohamed Keheila, MD Loma Linda University Medical Center
More Information
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Publications:

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Responsible Party: D. Duane Baldwin, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT02811601    
Other Study ID Numbers: 5160133
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by D. Duane Baldwin, Loma Linda University:
Minimally Invasive Surgical Procedures
Additional relevant MeSH terms:
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Urologic Diseases