Clinical trial NCT02308631: Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy
Official title: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colonic Neoplasms
Rectal Neoplasms
Fecal Incontinence
Keywords: Endoscopic, Colostomy, Colopexy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: LEONARDO ALFONSO BUSTAMANTE L
name: MARIANNY NAZARETH SULBARAN N
name: PAULO SAKAI
name: EDUARDO MOURA
name: CRISTIANO SAKAI
name: CAIO SERGIO NAHAS
name: CARLOS FREDERICO MARQUES
name: IVAN CECONELLO
name: SERGIO CARLOS NAHAS
First posted: 2014-12-04
Enrollment: 5
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* good health and without surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Safety and Tolerability of the procedure
timeFrame: 7 days
Secondary outcomes:
measure: Number of animals with Adverse Events in the colostomy.
timeFrame: 7 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Medicine School, Sao Paulo University
Study officials:
affiliation: University of Sao Paulo
name: Leonardo A Bustamante, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.