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

• ClinicalTrials.gov Identifier: NCT02308631
• Recruitment Status: Completed
• First Posted: December 4, 2014
• Last Update Posted: December 4, 2014
• Sponsor: University of Sao Paulo
• 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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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:

-

Contacts and Locations

Locations

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

• Principal Investigator: Leonardo A Bustamante, MD; University of Sao Paulo

More Information

Publications of Results:

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.

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.

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.

• 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
• 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:

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