Evidence map›Paper›PMID 38408943›Full record

ArticleBMC surgery2024

Optimising surgical anastomosis in ileocolic resection for Crohn's disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES).

Anouck E G Haanappel, Vittoria Bellato, Christianne J Buskens, Alessandro Armuzzi, Jarmila D W van der Bilt, Nanne K H de Boer, Silvio Danese, Eline M L van der Does de Willebois, Marjolijn Duijvestein, Daniëlle van der Horst and 7 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
7.7field-weighted citation impact, top 3% of its field
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.

NCT05246917 naunknown statusnot on this map

Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)

TypeinterventionalSponsorIRCCS San RaffaeleRan2022 to 2024Enrolled189ConditionsCrohn Disease, IBD, Ileocolitis, Crohn's IleocolitisArmsHandsewn anastomosis
NCT05578235 narecruitingnot on this map

Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2023 to 2027Enrolled165ConditionsCrohn DiseaseArmsstapled side-to-side anastomosis, Handsewn anastomosis
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 2 countries.

Anouck E G Haanappel *Department of Surgery, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1105, AZ, Amsterdam, The Netherlands. a.e.g.haanappel@amsterdamumc.nl.
Vittoria Bellato *Department of Minimally invasive surgery, Tor Vergata University of Rome, Rome, Italy.
Christianne J BuskensDepartment of Surgery, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1105, AZ, Amsterdam, The Netherlands.
Alessandro ArmuzziDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Jarmila D W van der BiltDepartment of Surgery, Flevoziekenhuis, Almere, The Netherlands.
Nanne K H de BoerDepartment of Gastroenterology and Hepatology, AGEM Research Institute, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Silvio DaneseGastroenterology and Gastrointestinal Endoscopy Unit, IRCCS Ospedale San Raffaele, Vita e Salute University, Milan, Italy.
Eline M L van der Does de WilleboisDepartment of Surgery, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1105, AZ, Amsterdam, The Netherlands.
Marjolijn DuijvesteinDepartment of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands.
Daniëlle van der HorstCrohn & Colitis NL, Woerden, The Netherlands.
Gianluca PellinoDepartment of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Milan C RichirDepartment of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Francesco SelvaggiDepartment of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Antonino SpinelliDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Andrea VignaliUnit of Coloproctology and IBD Surgery, IRCCS Ospedale San Raffaele, Vita e Salute University, Milan, Italy. vignali.andrea@hsr.it.
Riccardo RosatiDepartment of Gastrointestinal Surgery, IRCCS Ospedale San Raffaele, Vita e Salute University, Milan, Italy.
Willem A BemelmanDepartment of Surgery, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1105, AZ, Amsterdam, The Netherlands. w.a.bemelman@amsterdamumc.nl.
IRCCS Ospedale San Raffaele · ITAmsterdam University Medical Centers · NLHumanitas University · ITUniversity of Campania "Luigi Vanvitelli" · ITFlevoziekenhuis · NLRadboud University Medical Center · NLUniversity Medical Center Utrecht · NLUniversity of Amsterdam · NLUniversity of Rome Tor Vergata · ITVrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe most common intestinal operation in Crohn's disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection for example, handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. The objective of the present study is to compare the three types of anastomoses with respect to endoscopic recurrence at 6 months, gastrointestinal function, and health care consumption.

methodsThis is a randomized controlled multicentre superiority trial, allocating patients either to side-to-side stapled anastomosis as advised in current guidelines or a handsewn anastomoses (an end-to-end or Kono-S). It is hypothesized that handsewn anastomoses do better than stapled, and end-to-end perform better than the saccular Kono-S. Two international studies with a similar setup will be conducted mainly in the Netherlands (End2End) and Italy (HAND2END). Patients diagnosed with CD, aged over 16 years in the Netherlands and 18 years in Italy requiring (re)resection of the (neo)terminal ileum are eligible. The first part of the study compares the two handsewn anastomoses with the stapled anastomosis. To detect a clinically relevant difference of 25% in endoscopic recurrence, a total of 165 patients will be needed in the Netherlands and 189 patients in Italy. Primary outcome is postoperative endoscopic recurrence (defined as Rutgeerts score ≥ i2b) at 6 months. Secondary outcomes are postoperative morbidity, gastrointestinal function, quality of life (QoL) and costs. DISCUSSION: The research question addresses a knowledge gap within the general practice elucidating which type of anastomosis is superior in terms of endoscopic and clinical recurrence, functionality, QoL and health care consumption. The results of the proposed study might change current practice in contrast to what is advised by the guidelines.

trial registrationNCT05246917 for HAND2END and NCT05578235 for End2End ( http://www. CLINICALTRIALS: gov/ ).

Indexed as

Crohn DiseaseAdolescentAdultAnastomosis, SurgicalColonEquivalence Trials as TopicHumansIleumMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicRecurrenceCDCrohn’s diseaseEndoscopic recurrenceHandsewn anastomosisIBDIleocaecal resectionIleocolic anastomosisKono-SStapled anastomosisSurgical recurrence

Identifiers

PMID38408943
PMCPMC10895856
OpenAlexW4392161887

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.