Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy

Phase 1

Completed

• Conditions: Colonic Neoplasms; Fecal Incontinence; Rectal Neoplasms
• Interventions: Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY

• Registration Number: NCT02308631
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Study First Submitted: 2014-09-24
• Status Verified: 2014-10
• Study First Submitted QC: 2014-12-01
• Last Update Submitted: 2014-12-01
• Study First Posted: 2014-12-04
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• good health and without surgery

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colostomy with colopexy by endoscopy	ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY	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

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of the procedure	7 days	Feeding and mobilization of the animal, post procedure

Secondary Outcome Measures

Name	Time	Method
Number of animals with Adverse Events in the colostomy.	7 days	color of the edges and lost of function of the colostomy

Trial Locations

Locations (1)

Medicine School, Sao Paulo University; 🇧🇷 Sao Paulo, Brazil