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A multicentre randomised controlled trial of the modified Kono S anastomosis versus the stapled side to side anastomosis after ileocolic resection for Crohn’s disease

A multicentre randomised controlled trial of the effect of the modified Kono S anastomosis versus the stapled side to side anastomosis on disease recurrence after ileocolic resection for Crohn’s disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000809730
Enrollment
28
Registered
2022-06-09
Start date
2023-08-11
Completion date
2026-12-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Crohn’s disease (CD) is a chronic inflammatory bowel disease that occurs in a genetically susceptible individual in response to an unknown environmental stimulus. The incidence in Western populations is estimated to be between 5 to 7 per 100 000. 1 It is estimated that 80% of patients require surgery at some point in their life and of these, 70% require a further operation. After surgery, symptomatic recurrence is common and estimated at 28% and 36% at five and ten years post-operative (Bernell et al, Risk factors for surgery and recurrence in 907 patients with primary ileocaecal Crohn's disease. British J Surgery. 2000; 87:169). Endoscopic recurrence (ER) is even more common with up to 90% of patients found to have ER at 12 months. (Rutgeerts P, Get al. Natural history of recurrent Crohn's disease at the ileocolonic anastomosis after curative surgery. Gut. 1984). Emerging evidence suggests that the anastomotic configuration has a role in the recurrence rate. In 2003, a new approach to anastomosis was described, the Kono-S anastomosis, showing better surgery free rates compared to end-to-end anastomosis (preferred approach). Since the early observations, many other studies have presented outcomes in favour of the Kono-S anastomosis in the management of CD. Data suggest further research is needed to determine the optimal anastomotic configuration that can return the lowest recurrence rate and lowest complications for patients with CD requiring surgical management.

Interventions

Surgical procedure: Modified Kono S anastomosis after ileocolic resection. The intestine is transected by use of a linear staple cutter such that the mesentery is in the middle of the staple line and at a 90° angle to it. Then, the staple lines are sutured together transversely to create a supporting column that is designed to support the eventual dimension of the anastomosis. Longitudinal enterotomies of 7 cm length are then performed at the antimesenteric aspect, beginning 1 cm from the suppo

Surgical procedure: Modified Kono S anastomosis after ileocolic resection. The intestine is transected by use of a linear staple cutter such that the mesentery is in the middle of the staple line and at a 90° angle to it. Then, the staple lines are sutured together transversely to create a supporting column that is designed to support the eventual dimension of the anastomosis. Longitudinal enterotomies of 7 cm length are then performed at the antimesenteric aspect, beginning 1 cm from the supporting column. The anastomosis is then created transversely in a hand-sewn fashion. Operative time: median:256 min Adherence and Quality Assurance (QA) documented in surgical report Surgical procedure preformed by: Accredited surgeon with training in Kono-S anastomosis, -must be a member of Colorectal Society of Surgeons Australia and New Zealand (CSSANZ), -experience with Inflammatory Bowel Disease (IBD) surgical management, -a minimum of 20 ileocolic resections - express interest in the multi-centre randomised controlled trial investigating the effect of Kono-S anastomotic approach

Sponsors

Royal Brisbane Brisbane & Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults, 18 years and over. Crohn’s disease as diagnosed in accordance with the Lennard-Jones criteria. First or second ileocolic resection. Willingness to comply with study requirements and follow up. Surgery to be performed within 30 days of randomization. Provide written informed consent.

Exclusion criteria

Emergency surgery where randomisation or informed consent is not possible. Two or more prior ileocolic resections. Oral Steroids at 20mg prednisone or over for 4 weeks or equivalent, prior to surgery. Any patient whose medical condition requires a stoma. Pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026