NCT02631967

Brief Summary

Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD). This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis. In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery. Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

November 29, 2015

Last Update Submit

February 13, 2017

Conditions

Crohn Disease

Keywords

Crohn diseaseileocecal resectionanastomosisKono

Outcome Measures

Primary Outcomes (2)

  • Grade of endoscopic recurrence

    Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.

    6 Months

  • Surgical recurrence

    Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery

    Up to 5 years

Secondary Outcomes (9)

  • Endoscopic recurrence

    6 months up to 5 years

  • Grade of endoscopic recurrence

    6 months up to 5 years

  • Clinical recurrence

    Up to 5 years

  • Operating time

    Intraoperatively

  • Anastomosis time

    Intraoperatively

  • +4 more secondary outcomes

Study Arms (2)

Kono anastomosis

EXPERIMENTAL

Patients receiving Kono anastomosis

Procedure: Kono anastomosis

Stapled side-to-side anastomosis

EXPERIMENTAL

Patients receiving stapled side-to-side anastomosis

Procedure: Stapled side-to-side anastomosis

Interventions

Kono anastomosisPROCEDURE

Kono anastomosis

Kono anastomosis
Stapled side-to-side anastomosisPROCEDURE

Stapled side-to-side anastomosis

Stapled side-to-side anastomosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Crohn's disease requiring ileocecal resection

You may not qualify if:

  • age \> 75 years
  • age \< 18 years
  • inability to give the consent to the participation in the trial
  • refusal to participate in the trial after receiving accurate information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II

Napoli, 80121, Italy

RECRUITING

Related Publications (2)

  • Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.

    PMID: 21471760BACKGROUND

  • Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial. Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821.

    PMID: 32675483DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Luigi Bucci, Prof

    Federico II University of Naples

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Bucci, Prof

CONTACT

00390817462850luigi.bucci@unina.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2015

First Posted

December 16, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2022

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

IT(1)