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ArticleTrials2025

Extended mesenteric resection in Crohn's disease: EXCEED Study Protocol-a blinded multicenter randomized controlled clinical trial (RCT).

Jens Kristian Bælum, Jacob Rosenberg, Pernille Larsen, Maiken Joergensen, Hanna De La Croix, Eva Haglind, Eva Agenete, BEAT-IBD research group, Jens Kjeldsen, Mark Bremholm Ellebaek

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06324838 (Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06324838 narecruitingnot on this map

Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.

TypeinterventionalSponsorOdense University HospitalRan2025 to 2029Enrolled204ConditionsCrohn's Disease of Terminal IleumArmsStandard laparoscopic ileocecal resection, Extended laparoscopic ileocecal resection
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Jens Kristian BælumDepartment of Surgery, Odense University Hospital, Odense, Denmark. jens.kristian.baelum@rsyd.dk.ORCID http://orcid.org/0000-0003-0135-2430
Jacob RosenbergHerlev University Hospital, Herlev, Denmark.
Pernille LarsenDepartment of Surgery, Vejle Hospital, Vejle, Denmark.
Maiken JoergensenDepartment of Gastroenterology, Vejle Hospital, Vejle, Denmark.
Hanna De La CroixDepartment of Surgery, Sahlgrenska University Hospital/Östra and Sahlgrenska Academy, Gothernburg, Sweden.
Eva HaglindDepartment of Surgery, Sahlgrenska University Hospital/Östra and Sahlgrenska Academy, Gothernburg, Sweden.
Eva AgeneteDepartment of Surgery, Sahlgrenska University Hospital/Östra and Sahlgrenska Academy, Gothernburg, Sweden.
BEAT-IBD research group
Jens KjeldsenDepartment of Gastrointestinal Diseases, Odense University Hospital, Odense, Denmark.
Mark Bremholm EllebaekDepartment of Surgery, Odense University Hospital, Odense, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCrohn's disease presents a persistent challenge, particularly concerning disease recurrence in patients after previous intestinal resection. This recurrence often necessitates additional medical treatment or surgery, imposing a substantial burden on patients, healthcare systems, and society. Emerging evidence suggests that extended mesenteric excision may reduce recurrence. The EXCEED study aims to investigate the mesentery's influence on disease recurrence in Crohn's disease. METHODS/

designBlinded multicenter randomized controlled clinical trial involving 208 patients. Patients will undergo randomization into two groups: Group A, the treatment group, will receive extended mesenteric resection, while Group B, the control group, will undergo the standard resection with the mesentery largely preserved. Stratification will occur based on preoperative medicinal treatment categories (none, immunological, biological) and the treatment facility at the time of inclusion. This randomized controlled trial will incorporate blinding procedures, with the understanding that due to the nature of this interventional surgical study, the operating surgeon cannot be blinded. Primary endpoint is endoscopic signs of recurrence, defined as a modified Rutgeerts score > i2a, at the 12-month follow-up ileo-colonoscopy. Secondary endpoints include clinical recurrence at 6 and 12 months, as well as recurrence at 3 and 5 years postoperatively. Tertiary endpoints are; impact of disease severity at the time of operation, according to the Montreal classification, impact of biological treatment on recurrence rates, postoperative complications burden according to the Comprehensive Complication Index (CCI), patient reported outcome through questionnaires (5Q-5D-5L and SIBDQ) and cost-effectiveness analysis. DISCUSSION: This study addresses a critical gap in Crohn's disease literature, aiming to provide evidence on the impact of extended mesenteric excision in preventing disease recurrence, thereby contributing to enhanced patient outcomes.

trial registrationClinicalTrials.gov NCT06324838. Registered on 04/02/2024.

Indexed as

ColectomyCrohn DiseaseMesenteryAdultFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicRecurrenceTime FactorsTreatment OutcomeCrohn’s diseaseEndoscopyIleo-cecal resectionSurgical management

Identifiers

PMID41272703
PMCPMC12639701

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.