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

NCT02308631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-12-04

No results posted yet for this study

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.

Conditions

  • Colonic Neoplasms
  • Rectal Neoplasms
  • Fecal Incontinence

Interventions

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

Sponsors & Collaborators

  • LEONARDO ALFONSO BUSTAMANTE L

    collaborator UNKNOWN
  • MARIANNY NAZARETH SULBARAN N

    collaborator UNKNOWN
  • PAULO SAKAI

    collaborator UNKNOWN
  • EDUARDO MOURA

    collaborator UNKNOWN
  • CRISTIANO SAKAI

    collaborator UNKNOWN
  • CAIO SERGIO NAHAS

    collaborator UNKNOWN
  • CARLOS FREDERICO MARQUES

    collaborator UNKNOWN
  • IVAN CECONELLO

    collaborator UNKNOWN
  • SERGIO CARLOS NAHAS

    collaborator UNKNOWN
  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Leonardo A Bustamante, MD · University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308631 on ClinicalTrials.gov