Postoperative Disease RecurrenceNCT02542904
Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease
A study testing mesenteric excision in people with Postoperative Disease Recurrence and Crohns Disease, run by Jinling Hospital, China at 1 site in China.
Trial summary
Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Disease Recurrence, Crohns Disease
- What is being tested?
- mesenteric excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 1 Sep 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease limited to the distal ileum and/or right colon
Who cannot join
- Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion
Trial locations and contacts
1 site in 1 country.
About this study
Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.
Read the detailed description
Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups.
All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.
- Conditions
- Postoperative Disease Recurrence, Crohns Disease
- Being tested
- mesenteric excision
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenteric excisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LME | Active comparator | the anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel Receives: Procedure: mesenteric excision |
| EME | Active comparator | the anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue. Receives: Procedure: mesenteric excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative endoscopic recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion1 Sep 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Disease RecurrenceStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542904
- Sponsor's protocol ID
- EME vs. LME
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease
- ClinicalTrials.gov ID
- NCT02542904
- Acronym / sponsor ID
- EME vs. LME
- Conditions
- Postoperative Disease Recurrence, Crohns Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 7 Sep 2015 (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.
Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.
Detailed description
Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups.
All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LME | Active comparator | Procedure: mesenteric excisionthe anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel |
| EME | Active comparator | Procedure: mesenteric excisionthe anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Crohn's disease limited to the distal ileum and/or right colon
Key exclusion criteria (1 listed)
- Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion
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 |
|---|---|---|
| mesenteric excision | Procedure or surgery | EME, LME |
Primary outcome
postoperative endoscopic recurrence
Time frame: 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 7 Sep 2018.
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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 mesenteric excision in people with Postoperative Disease Recurrence and Crohns Disease, run by Jinling Hospital, China at 1 site in China.
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 7 Sep 2018. 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 China. 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?
postoperative endoscopic recurrence (time frame: 12 months). 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 7 Sep 2018.