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

Fecal Incontinence Clinical Trial

— EACC  

Official title:

ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308631
• Other study ID #: 12267
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2014
• Last updated: December 1, 2014
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• good health and without surgery

Exclusion Criteria:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Critical Illness
• Fecal Incontinence
• Neoplasms
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Medicine School, Sao Paulo University	Sao Paulo

Sponsors (10)

Lead Sponsor	Collaborator
University of Sao Paulo	CAIO SERGIO NAHAS, CARLOS FREDERICO MARQUES, CRISTIANO SAKAI, EDUARDO MOURA, IVAN CECONELLO, LEONARDO ALFONSO BUSTAMANTE L, MARIANNY NAZARETH SULBARAN N, PAULO SAKAI, SERGIO CARLOS NAHAS

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Hellinger MD, Martinez SA, Parra-Davila E, Yeguez J, Sands LR. Gasless laparoscopic-assisted intestinal stoma creation through a single incision. Dis Colon Rectum. 1999 Sep;42(9):1228-31. — View Citation

Mattingly M, Wasvary H, Sacksner J, Deshmukh G, Kadro O. Minimally invasive, endoscopically assisted colostomy can be performed without general anesthesia or laparotomy. Dis Colon Rectum. 2003 Feb;46(2):271-3. — View Citation

Senapati A, Phillips RK. The trephine colostomy: a permanent left iliac fossa end colostomy without recourse to laparotomy. Ann R Coll Surg Engl. 1991 Sep;73(5):305-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of the procedure	Feeding and mobilization of the animal, post procedure	7 days	No
Secondary	Number of animals with Adverse Events in the colostomy.	color of the edges and lost of function of the colostomy	7 days	No

External Links

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