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OpenTrials
Completed

NCT Number: NCT02308631

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

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.

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fecal Incontinence Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Medicine School, Sao Paulo University

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good health and without surgery

Exclusion criteria

-

Treatment and study plan

ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY

Procedure

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

Primary outcomes

  1. Safety and Tolerability of the procedure

    Time frame: 7 days

    Feeding and mobilization of the animal, post procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: EACC

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2014
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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