Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy (EACC)
Primary Purpose
Colonic Neoplasms, Rectal Neoplasms, Fecal Incontinence
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring Endoscopic, Colostomy, Colopexy
Eligibility Criteria
Inclusion Criteria:
- good health and without surgery
Exclusion Criteria:
-
Sites / Locations
- Medicine School, Sao Paulo University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colostomy with colopexy by endoscopy
Arm Description
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
Outcomes
Primary Outcome Measures
Safety and Tolerability of the procedure
Feeding and mobilization of the animal, post procedure
Secondary Outcome Measures
Number of animals with Adverse Events in the colostomy.
color of the edges and lost of function of the colostomy
Full Information
NCT ID
NCT02308631
First Posted
September 24, 2014
Last Updated
December 1, 2014
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
1. Study Identification
Unique Protocol Identification Number
NCT02308631
Brief Title
Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy
Acronym
EACC
Official Title
ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Rectal Neoplasms, Fecal Incontinence
Keywords
Endoscopic, Colostomy, Colopexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colostomy with colopexy by endoscopy
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
Intervention Description
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 Outcome Measure Information:
Title
Safety and Tolerability of the procedure
Description
Feeding and mobilization of the animal, post procedure
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of animals with Adverse Events in the colostomy.
Description
color of the edges and lost of function of the colostomy
Time Frame
7 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good health and without surgery
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo A Bustamante, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine School, Sao Paulo University
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
12576903
Citation
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.
Results Reference
result
PubMed Identifier
1929133
Citation
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.
Results Reference
result
PubMed Identifier
10496568
Citation
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.
Results Reference
result
Learn more about this trial
Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy
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