Rectal CancerPhase 2NCT00457327
Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer
A Phase 2 study testing protective ileostomy in people with Rectal Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- protective ileostomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Mar 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radical resectable rectal cancer
- low sphincter-preserving resection of carcinomas of the lower and middle third
- preoperative normal continence
- preoperative normal sphincter function
- complete rings after stapler anastomosis
- impermeability of anastomosis for air
- written informed consent
Who cannot join
- reduced cooperation or drug abuse
- pregnancy
- psychosis
- age under 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Study Center Surgery, Department of Surgery, University of Heidelberg
Heidelberg, 69120
About this study
The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer
Read the detailed description
Since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. There is no valid data about the need of protective ileostomy in these patients. About 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. Aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. Therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. In the event of clinical impairment in the postoperative course CT scan with KM filling of the rectum to exclude insufficiency of the anastomosis will be performed. In case of insufficiency protective ileostomy will be created. 40 patients will be included.
Comparison: Patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.
- Conditions
- Rectal Cancer
- Being tested
- protective ileostomy
- Keywords
- protective ileostomy, rectal cancer, low anterior resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protective ileostomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity and mortality until day 30 postoperative
Secondary outcomes (2)
Quality of life
Ranking of factors influencing quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Markus W Buchler, Chairman, Principal investigator, Department of Surgery, University of Heidelberg, Medical SchoolPeter Kienle, Consultant, Study chair, Department of Surgery, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457327
- Sponsor's protocol ID
- 433/2005
- Status last verified
- Jun 2008
- First submitted
- 4 Apr 2007
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ulrich AB, Seiler C, Rahbari N, Weitz J, Buchler MW. Diverting stoma after low anterior resection: more arguments in favor. Dis Colon Rectum. 2009 Mar;52(3):412-8. doi: 10.1007/DCR.0b013e318197e1b1.
PubMed 19333040
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer
- ClinicalTrials.gov ID
- NCT00457327
- Acronym / sponsor ID
- 433/2005
- Conditions
- Rectal Cancer
- Keywords
- protective ileostomy, rectal cancer, low anterior resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 6 Apr 2007 (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.
The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer
Detailed description
Since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. There is no valid data about the need of protective ileostomy in these patients. About 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. Aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. Therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. In the event of clinical impairment in the postoperative course CT scan with KM filling of the rectum to exclude insufficiency of the anastomosis will be performed. In case of insufficiency protective ileostomy will be created. 40 patients will be included.
Comparison: Patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- radical resectable rectal cancer
- low sphincter-preserving resection of carcinomas of the lower and middle third
- preoperative normal continence
- preoperative normal sphincter function
- complete rings after stapler anastomosis
Key exclusion criteria (4 listed)
- reduced cooperation or drug abuse
- pregnancy
- psychosis
- age under 18 years
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 |
|---|---|---|
| protective ileostomy | Procedure or surgery | – |
Primary outcome
Morbidity and mortality until day 30 postoperative
2 secondary outcomes
Quality of life
Ranking of factors influencing quality of life
Results and safety
The study was stopped early (reason given: RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
- Derived from this study: PubMed 19333040Ulrich AB, Seiler C, Rahbari N, Weitz J, Buchler MW. Diverting stoma after low anterior resection: more arguments in favor. Dis Colon Rectum. 2009 Mar;52(3):412-8. doi: 10.1007/DCR.0b013e318197e1b1.
- Study Center of the German Surgical SocietyLink provided by the sponsor.
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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.
Markus W Buchler, Chairman principal investigator
Department of Surgery, University of Heidelberg, Medical School
Peter Kienle, Consultant study chair
Department of Surgery, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing protective ileostomy in people with Rectal Cancer, run by Heidelberg University at 1 site in Germany.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Jun 2008. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.). Results are not available in the source record.
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?
Morbidity and mortality until day 30 postoperative. 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 NCT00457327, which also lists 1 linked publication.
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 5 Jun 2008.