Postoperative Surgical RecurrenceNCT03769922
Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease
A study testing Extensive mesenteric resection and Limited mesenteric excision in people with Postoperative Surgical Recurrence, run by Jinling Hospital, China at 1 site in China.
Trial summary
The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Postoperative Surgical Recurrence
- What is being tested?
- Extensive mesenteric resection and Limited mesenteric excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2019to Jan 2025
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
- Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria
Who cannot join
- Pregnancy or willingness to become pregnant in the following year
- Previous ileocolic resection history
- Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
- Patients having an internal fistula which required resection of another segment of bowel
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210000
Yi Li
About this study
Official title: The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
Read the detailed description
EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.
EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
- Conditions
- Postoperative Surgical Recurrence
- Being tested
- Extensive mesenteric resection, Limited mesenteric excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive mesenteric resectionProcedure or surgery
The mesentery is resected avoiding the root region.
Limited mesenteric excisionProcedure or surgery
The mesentery is retained.
| Study group | Role | What they receive |
|---|---|---|
| Extensive mesenteric resection | Experimental | Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein. Receives: Procedure: Extensive mesenteric resection |
| Limited mesenteric excision | Active comparator | Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device). Receives: Procedure: Limited mesenteric excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated 5-year postoperative surgical recurrence
The requirement for repeat surgery for a Crohn's disease related indication.
Measured: 5 years after the first surgery
Secondary outcomes (2)
Accumulated 5-year endoscopic recurrence
Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)
Measured: 5 years after the first surgery
Accumulated 5-year clinical recurrence
The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.
Measured: 5 years after the first surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start18 Feb 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Surgical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Limerick, The Cleveland Clinic, Sixth Affiliated Hospital, Sun Yat-sen University, Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Weiming Zhu, Jinling Hospital, China
- Investigators
- Zhu Weiming, Principal investigator, Jinling Hospital, Nanjing, China.John Calvin Coffey, Principal investigator, University Hospital Limerick, Limerick, Ireland.Luca Stocchi, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769922
- Sponsor's protocol ID
- 2018NZKY-025-02
- Status last verified
- Feb 2019
- First submitted
- 6 Dec 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.
PubMed 29309546Li Y, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Cao L, Shen B, Li N, Li J. Visceral fat area is associated with a high risk for early postoperative recurrence in Crohn's disease. Colorectal Dis. 2015 Mar;17(3):225-34. doi: 10.1111/codi.12798.
PubMed 25307174Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24.
PubMed 30043133Li Y, Mohan H, Lan N, Wu X, Zhou W, Gong J, Shen B, Stocchi L, Coffey JC, Zhu W. Mesenteric excision surgery or conservative limited resection in Crohn's disease: study protocol for an international, multicenter, randomized controlled trial. Trials. 2020 Feb 21;21(1):210. doi: 10.1186/s13063-020-4105-x.
PubMed 32085793
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
- ClinicalTrials.gov ID
- NCT03769922
- Acronym / sponsor ID
- 2018NZKY-025-02
- Conditions
- Postoperative Surgical Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- University Hospital of Limerick, The Cleveland Clinic, Sixth Affiliated Hospital, Sun Yat-sen University, Sir Run Run Shaw Hospital
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Dec 2018 (actual)
- 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 study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
Detailed description
EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.
EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensive mesenteric resection | Experimental | Procedure: Extensive mesenteric resectionMesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein. |
| Limited mesenteric excision | Active comparator | Procedure: Limited mesenteric excisionMesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
- Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria
Key exclusion criteria (4 listed)
- Pregnancy or willingness to become pregnant in the following year
- Previous ileocolic resection history
- Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
- Patients having an internal fistula which required resection of another segment of bowel
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 |
|---|---|---|
| Extensive mesenteric resectionThe mesentery is resected avoiding the root region. | Procedure or surgery | Extensive mesenteric resection |
| Limited mesenteric excisionThe mesentery is retained. | Procedure or surgery | Limited mesenteric excision |
Primary outcome
Accumulated 5-year postoperative surgical recurrence
Time frame: 5 years after the first surgery
The requirement for repeat surgery for a Crohn's disease related indication.
2 secondary outcomes
Accumulated 5-year endoscopic recurrence
Time frame: 5 years after the first surgery
Accumulated 5-year clinical recurrence
Time frame: 5 years after the first surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 29309546Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.
- Background: PubMed 25307174Li Y, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Cao L, Shen B, Li N, Li J. Visceral fat area is associated with a high risk for early postoperative recurrence in Crohn's disease. Colorectal Dis. 2015 Mar;17(3):225-34. doi: 10.1111/codi.12798.
- Background: PubMed 30043133Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24.
- Derived from this study: PubMed 32085793Li Y, Mohan H, Lan N, Wu X, Zhou W, Gong J, Shen B, Stocchi L, Coffey JC, Zhu W. Mesenteric excision surgery or conservative limited resection in Crohn's disease: study protocol for an international, multicenter, randomized controlled trial. Trials. 2020 Feb 21;21(1):210. doi: 10.1186/s13063-020-4105-x.
- Individual participant dataSharing planned: No
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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.
Zhu Weiming principal investigator
Jinling Hospital, Nanjing, China.
John Calvin Coffey principal investigator
University Hospital Limerick, Limerick, Ireland.
Luca Stocchi principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensive mesenteric resection and Limited mesenteric excision in people with Postoperative Surgical Recurrence, 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 2 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yi, PhD (+86 13851843735, liyi.jlh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated 5-year postoperative surgical recurrence (time frame: 5 years after the first surgery). 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 NCT03769922, which also lists 4 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 27 Feb 2019.