Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
NCT ID: NCT01980043
Last Updated: 2019-07-30
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
10 participants
INTERVENTIONAL
2013-05-20
2018-03-22
Brief Summary
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Detailed Description
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Primary Outcomes
1. Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance
2. Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)
3. Sedation and local anesthesia feasibility: surgery completed without patient intubation
4. Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications
5. Long Term Clinical Outcomes: Rectal Prolapse Recurrence
Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected prospectively before, during, and after surgery.
Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rectal Prolapse
endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control.
endoluminal rectal prolapse repair under sedation
endoluminal rectal prolapse repair under sedation
Interventions
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endoluminal rectal prolapse repair under sedation
endoluminal rectal prolapse repair under sedation
Eligibility Criteria
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Inclusion Criteria
* BMI above 18 and ≤30
* ASA class 1-3
* willing to participate in the study
Exclusion Criteria
* Previous Abdominal Surgeries including abdominal wall repair with mesh
75 Years
100 Years
ALL
No
Sponsors
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Olympus
INDUSTRY
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Jeffrey W Milsom, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medical Center- NYPH
New York, New York, United States
Countries
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References
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Milsom JW, Trencheva K, Gadalla F, Abramovitz S, Garrett KA. Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects. J Laparoendosc Adv Surg Tech A. 2021 Aug;31(8):911-916. doi: 10.1089/lap.2019.0804. Epub 2020 Oct 21.
Other Identifiers
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1209013050
Identifier Type: -
Identifier Source: org_study_id
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