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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308631
Acronym
EACC
Enrollment
5
Registered
2014-12-04
Start date
2014-02-28
Completion date
2014-09-30
Last updated
2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Fecal Incontinence, Rectal Neoplasms

Keywords

Endoscopic, Colostomy, Colopexy

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.

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.

Interventions

PROCEDUREENDOSCOPICALLY 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

LEONARDO ALFONSO BUSTAMANTE L
CollaboratorUNKNOWN
MARIANNY NAZARETH SULBARAN N
CollaboratorUNKNOWN
PAULO SAKAI
CollaboratorUNKNOWN
EDUARDO MOURA
CollaboratorUNKNOWN
CRISTIANO SAKAI
CollaboratorUNKNOWN
CAIO SERGIO NAHAS
CollaboratorUNKNOWN
CARLOS FREDERICO MARQUES
CollaboratorUNKNOWN
IVAN CECONELLO
CollaboratorUNKNOWN
SERGIO CARLOS NAHAS
CollaboratorUNKNOWN
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* good health and without surgery

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Safety and Tolerability of the procedure7 daysFeeding and mobilization of the animal, post procedure

Secondary

MeasureTime frameDescription
Number of animals with Adverse Events in the colostomy.7 dayscolor of the edges and lost of function of the colostomy

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026