Rectal CancerNCT00956241
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
A study testing j-pouch coloanal anastomosis and side-to-end coloanal anastomosis in people with Rectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- j-pouch coloanal anastomosis and side-to-end coloanal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2002to Jan 2007
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.
Who cannot join
- Patients with a T1 or T4 tumor were excluded
- Patients diagnosed with distant metastases
- A medical history of colonic resection
- Anorectal surgery or chemo- radiotherapy
- Pre-existing fecal incontinence grade III or IV according to Parks10
- Life expectancy of less than one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.
Read the detailed description
Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.
- Conditions
- Rectal Cancer
- Being tested
- j-pouch coloanal anastomosis, side-to-end coloanal anastomosis
- Keywords
- rectal cancer, colonic pouch, side-to-end anastomosis, preoperative radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
j-pouch coloanal anastomosisProcedure or surgery
side-to-end coloanal anastomosisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| j-pouch coloanal anastomosis | Other | although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made. Receives: Procedure: j-pouch coloanal anastomosis |
| side-to-end coloanal anastomosis | Other | in the Netherlands, the side-to-end anastomosis is the standard procedure to perform an anastomosis in case of rectal resection. therefore, the side-to-end group was our control group Receives: Procedure: side-to-end coloanal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
Measured: 4 months
Secondary outcomes (3)
Function of the neo-rectum as assessed by the functional outcome questionnaire
Measured: 12 months
Surgical results
Measured: 4 and 12 months
Quality of life
Measured: 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startApr 2002
- Primary completionJan 2007
- Study completionJan 2007
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation, Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956241
- Sponsor's protocol ID
- WS 01-62
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doeksen A, Bakx R, Vincent A, van Tets WF, Sprangers MA, Gerhards MF, Bemelman WA, van Lanschot JJ. J-pouch vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision for rectal cancer: a multicentre randomized trial. Colorectal Dis. 2012 Jun;14(6):705-13. doi: 10.1111/j.1463-1318.2011.02725.x.
PubMed 21831100
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT00956241
- Acronym / sponsor ID
- WS 01-62
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, colonic pouch, side-to-end anastomosis, preoperative radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation, Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
- Study start
- Apr 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Aug 2009 (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 objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.
Detailed description
Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| j-pouch coloanal anastomosis | Other | Procedure: j-pouch coloanal anastomosisalthough a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made. |
| side-to-end coloanal anastomosis | Other | Procedure: side-to-end coloanal anastomosisin the Netherlands, the side-to-end anastomosis is the standard procedure to perform an anastomosis in case of rectal resection. therefore, the side-to-end group was our control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.
Key exclusion criteria (6 listed)
- Patients with a T1 or T4 tumor were excluded
- Patients diagnosed with distant metastases
- A medical history of colonic resection
- Anorectal surgery or chemo- radiotherapy
- Pre-existing fecal incontinence grade III or IV according to Parks10
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 |
|---|---|---|
| j-pouch coloanal anastomosis | Procedure or surgery | j-pouch coloanal anastomosis |
| side-to-end coloanal anastomosis | Procedure or surgery | side-to-end coloanal anastomosis |
Primary outcome
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
Time frame: 4 months
3 secondary outcomes
Function of the neo-rectum as assessed by the functional outcome questionnaire
Time frame: 12 months
Surgical results
Time frame: 4 and 12 months
Quality of life
Time frame: 4 and 12 months
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 11 Aug 2009.
- Derived from this study: PubMed 21831100Doeksen A, Bakx R, Vincent A, van Tets WF, Sprangers MA, Gerhards MF, Bemelman WA, van Lanschot JJ. J-pouch vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision for rectal cancer: a multicentre randomized trial. Colorectal Dis. 2012 Jun;14(6):705-13. doi: 10.1111/j.1463-1318.2011.02725.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing j-pouch coloanal anastomosis and side-to-end coloanal anastomosis in people with Rectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 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 11 Aug 2009. 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 Netherlands. 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.
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?
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months. (time frame: 4 months). 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 NCT00956241, 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 11 Aug 2009.