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

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms; Colonic Neoplasms; Fecal Incontinence
• Intervention / Treatment: Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-900
    • Medicine School, Sao Paulo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• good health and without surgery

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of the procedure	Feeding and mobilization of the animal, post procedure	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of animals with Adverse Events in the colostomy.	color of the edges and lost of function of the colostomy	7 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. doi: 10.1007/s10350-004-6534-0.
• 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. doi: 10.1007/BF02238581.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Endoscopic, Colostomy, Colopexy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Fecal Incontinence
• Other Study ID Numbers: 12267 (Other Identifier: City of Hope Medical Center)