NCT02308631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
Last Updated

December 4, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

September 24, 2014

Last Update Submit

December 1, 2014

Conditions

Colonic NeoplasmsRectal NeoplasmsFecal Incontinence

Keywords

Endoscopic, Colostomy, Colopexy

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of the procedure

    Feeding and mobilization of the animal, post procedure

    7 days

Secondary Outcomes (1)

  • Number of animals with Adverse Events in the colostomy.

    7 days

Study Arms (1)

Colostomy with colopexy by endoscopy

EXPERIMENTAL

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

Interventions

ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXYPROCEDURE

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

Colostomy with colopexy by endoscopy

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • good health and without surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine School, Sao Paulo University

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 12576903RESULT

  • 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.

    PMID: 1929133RESULT

  • 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.

    PMID: 10496568RESULT

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsFecal Incontinence

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Leonardo A Bustamante, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Colon and Rectal surgeon

Study Record Dates

First Submitted

September 24, 2014

First Posted

December 4, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-10

Locations

BR(1)