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Trial record 1 of 5 for:    Leonardo Alfonso Bustamante
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Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy (EACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02308631
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborators:
LEONARDO ALFONSO BUSTAMANTE L
MARIANNY NAZARETH SULBARAN N
PAULO SAKAI
EDUARDO MOURA
CRISTIANO SAKAI
CAIO SERGIO NAHAS
CARLOS FREDERICO MARQUES
IVAN CECONELLO
SERGIO CARLOS NAHAS
Information provided by (Responsible Party):
Leonardo Alfonso Bustamante, University of Sao Paulo

Brief 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.


Condition or disease Intervention/treatment Phase
Colonic Neoplasms Rectal Neoplasms Fecal Incontinence Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY Phase 1

Detailed Description:

The colonoscope will be passed transanally into the left colon. It will be identified the endoscopic transilluminating point to the abdominal wall. Percutaneous anterior colopexy will be performed, using a gastropexy device that is included in the percutaneous endoscopic gastrostomy (PEG) kit . This technique involves the placement of a threaded nylon fastener into the colon through a needle.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: 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
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




Primary Outcome Measures :
  1. Safety and Tolerability of the procedure [ Time Frame: 7 days ]
    Feeding and mobilization of the animal, post procedure


Secondary Outcome Measures :
  1. Number of animals with Adverse Events in the colostomy. [ Time Frame: 7 days ]
    color of the edges and lost of function of the colostomy



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • good health and without surgery

Exclusion Criteria:

-


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): NCT02308631


Locations
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Brazil
Medicine School, Sao Paulo University
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
LEONARDO ALFONSO BUSTAMANTE L
MARIANNY NAZARETH SULBARAN N
PAULO SAKAI
EDUARDO MOURA
CRISTIANO SAKAI
CAIO SERGIO NAHAS
CARLOS FREDERICO MARQUES
IVAN CECONELLO
SERGIO CARLOS NAHAS
Investigators
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Principal Investigator: Leonardo A Bustamante, MD University of Sao Paulo
Publications of Results:
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Responsible Party: Leonardo Alfonso Bustamante, M.D. Colon and Rectal surgeon, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02308631    
Other Study ID Numbers: 12267
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: October 2014
Keywords provided by Leonardo Alfonso Bustamante, University of Sao Paulo:
Endoscopic, Colostomy, Colopexy
Additional relevant MeSH terms:
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Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases