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

Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD); Crohn Disease of Ileum; Kono S Anastomosis; Extended Mesenteric Excision
• Intervention / Treatment: Procedure: Mesenteric excision and exclusion

Detailed Description

Crohn's disease is a chronic inflammatory disease that can affect any part of the gastrointestinal tract. The underlying etiology is still unknown, but it is perceived multifactorial and the effect of environmental and pathophysiological factors on a genetically predisposed individual.

Although the development of new pharmacological agents has revolutionized the management of Crohn's disease, the rates of endoscopic and surgical reoccurrence still remain discouraging. It is estimated that 50% of patients with Crohn's disease will require surgical intervention and the rate of surgical reoccurrence remains as high as 30% at 10 years.

Since most reoccurrences occur near or around the anastomotic site, the type of resection and anastomosis has been extensively reviewed in the past, but no significant differences have been observed. In the later years two new surgical techniques have been developed (extended mesenteric excision and Kono-S anastomosis), and increasing data show that they could potentially reduce the rate of reoccurrence. Both techniques focus on the role of the mesentery on disease reoccurrence. The extended mesenteric excision removes the mesentery and corresponding lymphatics of the affected bowel while the Kono-S anastomosis excludes the mesentery from the overlying wide anastomosis. The combination of the two techniques has been termed "mesenteric excision and exclusion" The primary goal of this study is to assess the safety the mesenteric excision and exclusion for Crohn's diseases disease of the terminal ileum in a central hospital of Greece. All intra and postoperative complications within 30 days will be collected and reviewed.

As secondary goals, the endoscopic, clinical and surgical reoccurrence will be reviewed at 6 months, 2 years and 5 years after the operation.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Panagiotis Dikeakos, Consultant; Phone Number: 6948517126 Greece; Email: dikeakosp@hotmail.com

Study Locations

• Greece
  • Attica
    • Piraeus, Attica, Greece, 18536
      • Recruiting
      • General Hospital Of Piraeus "Tzaneio"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Community based study

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn's disease of the terminal ileum; Patients with Crohn's disease of the terminal ileum requiring surgical intervention	Procedure: Mesenteric excision and exclusion; Laparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the procedure	Collection of intra and post operative complication rate	30 days post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic reoccurence	Endoscopic reoccurrence according to Rutgeert's score	6 months, 2 years and 5 years post intervention
Clinical reoccurrence	Clinical symptoms severe enough to require new endoscopy	Up to 5 years
Surgical reoccurrence	Repeat surgery because of reoccurrence at the proximity of the Kono-S anastomosis	Up to 5 years

Collaborators and Investigators

• Sponsor: Tzaneio General Hospital
• Investigators: Study Director: Georgios Ayiomamitis, General Hospital Of Piraeus "Tzaneio"

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: August 31, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Kono-s; extended mesenteric excision; mesenteric excision and exclusion
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 15094- 23/09/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient Characteristics
• IPD Sharing Time Frame: 01/01/2022- 31/12/2032
• IPD Sharing Access Criteria: The information is freely available
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No