Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07231601

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Of Piraeus "Tzaneio"

Piraeus, Attica, 18536, Greece

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Safety of the procedure

    Time frame: 30 days post intervention

    Collection of intra and post operative complication rate

Secondary outcomes

  1. Endoscopic reoccurence

    Time frame: 6 months, 2 years and 5 years post intervention

    Endoscopic reoccurrence according to Rutgeert's score

  2. Clinical reoccurrence

    Time frame: Up to 5 years

    Clinical symptoms severe enough to require new endoscopy

  3. Surgical reoccurrence

    Time frame: Up to 5 years

    Repeat surgery because of reoccurrence at the proximity of the Kono-S anastomosis

Study contacts

Contact information is provided by the study sponsor or research team.

Panagiotis Dikeakos, Consultant

CONTACT

[email protected]

Greece ext. 6948517126

Sponsors and collaborators

Lead sponsor

Tzaneio General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.