Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy (EACC)
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|ClinicalTrials.gov Identifier: NCT02308631|
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : December 4, 2014
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Safety and Tolerability of the procedure [ Time Frame: 7 days ]Feeding and mobilization of the animal, post procedure
- Number of animals with Adverse Events in the colostomy. [ Time Frame: 7 days ]color of the edges and lost of function of the colostomy
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
|Medicine School, Sao Paulo University|
|Sao Paulo, Brazil, 05403-900|
|Principal Investigator:||Leonardo A Bustamante, MD||University of Sao Paulo|