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The Remeasure Trial

NCT07164209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-10-08

No results posted yet for this study

Summary

Aim of the present study is to compare a stapled, functional end-to-end, ileo-colic anastomosis with removal of the mesentery vs the manual, functional end-to-end, ileo-colic Kono-S anastomosis with mesentery preservation, in terms of peri-operative safety, and efficacy in preventing endoscopic recurrence after ileocolic resection for Crohn Disease. Patients presenting with ileocolic primary Crohn disease either not suitable for medical treatment or with contraindications for therapy i.e: occlusion, abscess, contraindications to the use of biologics

Conditions

  • Ileocolic Crohn Disease
  • Kono S Anastomosis
  • Resection of the Mesentery

Interventions

PROCEDURE

Excision of the mesentery: the mesentery is fully dissected and excised to the limit of macroscopic "fat wrapping", where mesenteric fat is inflamed and extends beyond its normal anatomical distribut

The resection of mesentery could take off the inflammatory tissue who may increase the risk of anastomotic recurrence The Kono anastomosis achieves a column of support (made with the bowel ) located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lumen of the anastomosis being a barrier between anastomosis and mesentery

PROCEDURE

Kono S Anastomosis

ono-S anastomosis: the mesentery is not removed but cutted close to the bowel. The bowel is then divided transversely by placing a linear stapler perpendicular to the intestinal lumen and the mesentery. The corners of the two staple lines are reinforced and the two stumps are approximated using 5-7 sutures to create the column. If the caliber of the two intestinal segments differs significantly, the sutures should be spaced to evenly distribute the surplus tissue of the larger segment, in order to achieve good approximation and stable support for the anastomosis. To create the anastomosis, an antimesenteric longitudinal enterotomy (or colostomy) is performed on each stump to allow a transverse lumen of 7 cm in diameter for the small bowel or closer to 8 cm for the colon. In this way the supporting column is located immediately behind the posterior wall of the anastomosis providing a rigid and stable support to prevent mechanical deformation and functional constriction of the lum

Sponsors & Collaborators

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-02
Primary Completion
2024-12-30
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164209 on ClinicalTrials.gov