Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy
NCT02308631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2014-12-04
Summary
Indications for colostomy are rectal or anal cancer, diverticular disease, radiation enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and functional disorders. It is frequently required in critically ill patients who may not be able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for colostomy without laparotomy, but require general anesthesia.
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.
Conditions
- Colonic Neoplasms
- Rectal Neoplasms
- Fecal Incontinence
Interventions
- PROCEDURE
-
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
Sponsors & Collaborators
-
LEONARDO ALFONSO BUSTAMANTE L
collaborator UNKNOWN -
MARIANNY NAZARETH SULBARAN N
collaborator UNKNOWN -
PAULO SAKAI
collaborator UNKNOWN -
EDUARDO MOURA
collaborator UNKNOWN -
CRISTIANO SAKAI
collaborator UNKNOWN -
CAIO SERGIO NAHAS
collaborator UNKNOWN -
CARLOS FREDERICO MARQUES
collaborator UNKNOWN -
IVAN CECONELLO
collaborator UNKNOWN -
SERGIO CARLOS NAHAS
collaborator UNKNOWN -
University of Sao Paulo
lead OTHER
Principal Investigators
-
Leonardo A Bustamante, MD · University of Sao Paulo
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2014-08-31
- Completion
- 2014-09-30
Countries
- Brazil
Study Locations
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