Colonic NeoplasmsPhase 1EACCNCT02308631
Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy
A Phase 1 study testing ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY in people with Colonic Neoplasms and Rectal Neoplasms, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms, Rectal Neoplasms, Fecal Incontinence
- What is being tested?
- ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- good health and without surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medicine School, Sao Paulo University
São Paulo, São Paulo, 05403-900
About this study
Official title: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY
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.
Read the 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.
- Conditions
- Colonic Neoplasms, Rectal Neoplasms, Fecal Incontinence
- Being tested
- ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY
- Keywords
- Endoscopic, Colostomy, Colopexy
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXYProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of the procedure
Feeding and mobilization of the animal, post procedure
Measured: 7 days
Secondary outcomes (1)
Number of animals with Adverse Events in the colostomy.
color of the edges and lost of function of the colostomy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Leonardo Alfonso Bustamante, University of Sao Paulo
- Investigators
- Leonardo A Bustamante, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308631
- Sponsor's protocol ID
- 12267
- Acronym
- EACC
- Status last verified
- Oct 2014
- First submitted
- 24 Sep 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12576903Senapati 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.
PubMed 1929133Hellinger 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.
PubMed 10496568
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY
- ClinicalTrials.gov ID
- NCT02308631
- Acronym / sponsor ID
- EACC / 12267
- Conditions
- Colonic Neoplasms, Rectal Neoplasms, Fecal Incontinence
- Keywords
- Endoscopic, Colostomy, Colopexy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- 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
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colostomy with colopexy by endoscopy | Experimental | Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXYColostomy 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- good health and without surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXYThe 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 | Procedure or surgery | Colostomy with colopexy by endoscopy |
Primary outcome
Safety and Tolerability of the procedure
Time frame: 7 days
Feeding and mobilization of the animal, post procedure
1 secondary outcome
Number of animals with Adverse Events in the colostomy.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Results publication: PubMed 12576903Mattingly 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 publication: PubMed 1929133Senapati 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 publication: PubMed 10496568Hellinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo A Bustamante, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY in people with Colonic Neoplasms and Rectal Neoplasms, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of the procedure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308631, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.