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

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Colonic Neoplasms; Fecal Incontinence; Rectal Neoplasms

Treatments: Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY

Study type: Interventional

Funder types: Other

Identifiers

NCT02308631

12267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• good health and without surgery

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Colostomy with colopexy by endoscopy

Experimental group

Description:

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

Treatment:

Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY