Percutaneous Externally-Assembled Laparoscopic Urologic Surgery
NCT ID: NCT02811601
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2016-06-30
2022-05-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PEAL surgery
Patients will undergo percutaneous externally-assembled laparoscopic surgery
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unfit for laparoscopic surgery
18 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Mohamed Keheila, MD
Role: STUDY_DIRECTOR
Loma Linda University Medical Center
Locations
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Loma Linda Medical Center
Loma Linda, California, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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5160133
Identifier Type: -
Identifier Source: org_study_id
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