Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy
NCT ID: NCT02308631
Last Updated: 2014-12-04
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
PHASE1
5 participants
INTERVENTIONAL
2014-02-28
2014-09-30
Brief Summary
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Additionally, percutaneous anterior colopexy under colonocopic control offers the possibility for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall.
The objective of this study is to evaluate the feasibility of performing fecal diversion with the help of a colonoscope and colopexy, without the additional morbidity of abdominal exploration.
Detailed Description
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The endoscope will be manipulated until the light approaches the premarked site. A small skin disc will then be removed at this location and a loop colostomy will be made. The colonoscope will also be used as a guide to identify the proximal and distal limbs of the loop colostomy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Colostomy with colopexy by endoscopy
Colostomy with colopexy by endoscopy. 5 porks underwent endoscopic assisted colostomy with percutaneous colopexy. Animals were evaluated in post-operative days 1, 2, 5 and 7 Procedure/Surgery: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
The endoscope was manipulated until the light approached the pre-set for the use of transillumination site and puncture with the Loop Fixture II gastropexy kit
Interventions
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ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
The endoscope was manipulated until the light approached the pre-set for the use of transillumination site and puncture with the Loop Fixture II gastropexy kit
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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LEONARDO ALFONSO BUSTAMANTE L
UNKNOWN
MARIANNY NAZARETH SULBARAN N
UNKNOWN
PAULO SAKAI
UNKNOWN
EDUARDO MOURA
UNKNOWN
CRISTIANO SAKAI
UNKNOWN
CAIO SERGIO NAHAS
UNKNOWN
CARLOS FREDERICO MARQUES
UNKNOWN
IVAN CECONELLO
UNKNOWN
SERGIO CARLOS NAHAS
UNKNOWN
University of Sao Paulo
OTHER
Responsible Party
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Leonardo Alfonso Bustamante
M.D. Colon and Rectal surgeon
Principal Investigators
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Leonardo A Bustamante, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Medicine School, Sao Paulo University
São Paulo, São Paulo, Brazil
Countries
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References
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Mattingly M, Wasvary H, Sacksner J, Deshmukh G, Kadro O. Minimally invasive, endoscopically assisted colostomy can be performed without general anesthesia or laparotomy. Dis Colon Rectum. 2003 Feb;46(2):271-3. doi: 10.1007/s10350-004-6534-0.
Senapati A, Phillips RK. The trephine colostomy: a permanent left iliac fossa end colostomy without recourse to laparotomy. Ann R Coll Surg Engl. 1991 Sep;73(5):305-6.
Hellinger MD, Martinez SA, Parra-Davila E, Yeguez J, Sands LR. Gasless laparoscopic-assisted intestinal stoma creation through a single incision. Dis Colon Rectum. 1999 Sep;42(9):1228-31. doi: 10.1007/BF02238581.
Other Identifiers
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12267
Identifier Type: -
Identifier Source: org_study_id