Colo-rectal Anastomosis DehiscencePhase 3GILRRNCT01861379
The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
A Phase 3 study testing Ghost Ileostomy in people with Colo-rectal Anastomosis Dehiscence, run by University of Roma La Sapienza.
Trial summary
To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colo-rectal Anastomosis Dehiscence
- What is being tested?
- Ghost Ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2013
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical Indication for Laparoscopic Anterior Rectal Resection
- Medium risk of anastomotic leakage
Who cannot join
- High risk of anastomotic leakage
- Lower risk of anastomotic leakage
- Advanced neoplasia (T4)
- Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
- Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
About this study
To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. In the first group of patients at the end of the procedure was always performed a Ghost Ileostomy while in the second group no protective stoma was built at the end of the intervention.
- Conditions
- Colo-rectal Anastomosis Dehiscence
- Being tested
- Ghost Ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ghost IleostomyProcedure or surgery
Also called Virtual Ileostomy
At the end of Laparoscopic Anterior Rectal Resection, once the colorectal anastomosis was performed, the terminal ileum was identified and a window in the mesentery was created to pass a rubber tube (we usually use an urinary catheter) around the intestinal loop. The tube was subsequently exteriorized trough the trocar incision in the right flank.
| Study group | Role | What they receive |
|---|---|---|
| Ghost Ileostomy | Experimental | The patients were subjected to laparoscopic anterior rectal resection with performance of ghost ileostomy Receives: Procedure: Ghost Ileostomy |
| No protective stoma | Placebo comparator | The patients were subjected to laparoscopic anterior rectal resection without simultaneous construction of any protective stoma. Receives: Procedure: Ghost Ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Clinical Evident Anastomotic Leak
Measured: 15 days
Secondary outcomes (2)
Postoperative complication
Measured: 15 days
Ghost Ileostomy complications
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJan 2007
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal Anastomosis DehiscenceStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Saverio Mari, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861379
- Sponsor's protocol ID
- DS-008
- Acronym
- GILRR
- Status last verified
- Nov 2016
- First submitted
- 21 May 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
- ClinicalTrials.gov ID
- NCT01861379
- Acronym / sponsor ID
- GILRR / DS-008
- Conditions
- Colo-rectal Anastomosis Dehiscence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 May 2013 (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.
To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. In the first group of patients at the end of the procedure was always performed a Ghost Ileostomy while in the second group no protective stoma was built at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ghost Ileostomy | Experimental | Procedure: Ghost IleostomyThe patients were subjected to laparoscopic anterior rectal resection with performance of ghost ileostomy |
| No protective stoma | Placebo comparator | Procedure: Ghost IleostomyThe patients were subjected to laparoscopic anterior rectal resection without simultaneous construction of any protective stoma. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical Indication for Laparoscopic Anterior Rectal Resection
- Medium risk of anastomotic leakage
Key exclusion criteria (5 listed)
- High risk of anastomotic leakage
- Lower risk of anastomotic leakage
- Advanced neoplasia (T4)
- Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
- Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
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 |
|---|---|---|
| Ghost IleostomyAlso: Virtual IleostomyAt the end of Laparoscopic Anterior Rectal Resection, once the colorectal anastomosis was performed, the terminal ileum was identified and a window in the mesentery was created to pass a rubber tube (we usually use an urinary catheter) around the intestinal loop. The tube was subsequently exteriorized trough the trocar incision in the right flank. | Procedure or surgery | Ghost Ileostomy, No protective stoma |
Primary outcome
Presence of Clinical Evident Anastomotic Leak
Time frame: 15 days
2 secondary outcomes
Postoperative complication
Time frame: 15 days
Ghost Ileostomy complications
Time frame: 15 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 22 Nov 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ghost Ileostomy in people with Colo-rectal Anastomosis Dehiscence, run by University of Roma La Sapienza.
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 2 inclusion and 5 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Presence of Clinical Evident Anastomotic Leak (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.