Laparoscopic Right Hemicolectomy for Crohn's Disease of the Terminal Ileum Utilizing the Mesenteric Excision and Exclusion

NCT07231601 | Recruiting

• 1 other identifier: 15094- 23/09/2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed for patients requiring surgery for Crohn's disease of the terminal ileum. A combination of laparoscopic segmental right colectomy with extended mesenteric excision and the Kono-s anastomosis will be utilized. Since this is a fairly new technique, the intra and post operative complications will be reviewed. Also endoscopic, clinical and surgical reoccurrence will be reviewed at certain predefined time points post operatively.

Conditions

Crohn Disease (CD); Crohn Disease of Ileum; Kono S Anastomosis; Extended Mesenteric Excision

Keywords

Kono-s; extended mesenteric excision; mesenteric excision and exclusion

Outcome Measures

Primary Outcomes (1)

• Safety of the procedure

  Collection of intra and post operative complication rate

  30 days post intervention

Secondary Outcomes (3)

• Endoscopic reoccurence

  6 months, 2 years and 5 years post intervention

• Clinical reoccurrence

  Up to 5 years

• Surgical reoccurrence

  Up to 5 years

Study Arms (1)

Crohn's disease of the terminal ileum

Patients with Crohn's disease of the terminal ileum requiring surgical intervention

Procedure: Mesenteric excision and exclusion

Interventions

Mesenteric excision and exclusion PROCEDURE

Laparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis

Crohn's disease of the terminal ileum

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community based study

You may qualify if:

• Males and females aged \>16 years
• Ileocolic disease or disease of the terminal ileum with an indication for resection
• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
• All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))
• Ability to comply with protocol.
• Competent and able to provide written informed consent.

You may not qualify if:

• Inability to give informed consent.
• Patients less than 16 years of age.
• Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
• History of cancer \< 5 years which might influence patients prognosis
• Emergent operation.
• Pregnant or breast feeding.
• Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Sponsors & Collaborators

• Tzaneio General Hospital: lead

Study Sites (1)

General Hospital Of Piraeus "Tzaneio"

Piraeus, Attica, 18536, Greece

RECRUITING

Related Publications (3)

• Kono T, Fichera A, Maeda K, Sakai Y, Ohge H, Krane M, Katsuno H, Fujiya M. Kono-S Anastomosis for Surgical Prophylaxis of Anastomotic Recurrence in Crohn's Disease: an International Multicenter Study. J Gastrointest Surg. 2016 Apr;20(4):783-90. doi: 10.1007/s11605-015-3061-3. Epub 2015 Dec 22.

  PMID: 26696531 BACKGROUND

• 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.

  PMID: 29309546 BACKGROUND

• Holubar SD, Gunter RL, Click BH, Achkar JP, Lightner AL, Lipman JM, Hull TL, Regueiro M, Rieder F, Steele SR. Mesenteric Excision and Exclusion for Ileocolic Crohn's Disease: Feasibility and Safety of an Innovative, Combined Surgical Approach With Extended Mesenteric Excision and Kono-S Anastomosis. Dis Colon Rectum. 2022 Jan 1;65(1):e5-e13. doi: 10.1097/DCR.0000000000002287.

  PMID: 34882636 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Georgios Ayiomamitis

  General Hospital of Piraeus "Tzaneio"

  STUDY DIRECTOR

Central Study Contacts

Panagiotis Dikeakos, Consultant

CONTACT

Greece; dikeakosp@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 01/01/2022- 31/12/2032
• Access Criteria: The information is freely available

Locations

GR (1)