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RecruitingNCT05658081Updated Dec 20, 2022

Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study

An interventional study of Kono-S group and Side-to-side group in Crohn Disease and Recurrence, sponsored by Jinling Hospital, China. Recruiting at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
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Study summary

The postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients. Its impact on the postoperative recurrence of CD was unknown. Whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. The trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.

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Conditions studied

  • Crohn Disease
  • Recurrence
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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 236 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with Crohn's disease needing bowel resection and anastomosis;
  • ileocolic anastomosis;
  • written consent acquired

Exclusion criteria

Exclusion Criteria:

  • patients underwent enterostomy;
  • small bowel anastomosis;
  • anticipating other trial.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
236 participants (estimated)

Study arms

  • Experimental
    Kono-S group

    patients in this arm will receive stapled Kono-S anastomosis after bowel resection

    Procedure: Kono-S group

  • Other
    Side-to-side group

    patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection

    Procedure: Side-to-side group

Interventions

  • ProcedureKono-S group

    patients in this arm will receive stapled Kono-S anastomosis after bowel resection

  • ProcedureSide-to-side group

    patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection

06

What researchers measure

Primary outcomes

  1. the endoscopic recurrence rate at 1 year after surgery

    the endoscopic recurrence rate at 1 year after surgery

    Time frame: at 1 year after surgery(6-18month)

Secondary outcomes

  1. the clinical recurrence rate at 1 and 5 year after surgery

    the clinical recurrence rate at 1 and 5 year after surgery

    Time frame: 1 and 5 year after surgery

  2. the surgical recurrence rate at 1 and 5 year after surgery

    the surgical recurrence rate at 1 and 5 year after surgery

    Time frame: 1 and 5 year after surgery

  3. the endoscopic recurrence rate at 1 year after surgery

    the endoscopic recurrence rate at 1 year after surgery

    Time frame: 1 and 5 year after surgery

  4. quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)

    IBDQ , higher means better,IBDQ,7-224;

    Time frame: 1 and 5 year after surgery

  5. quality of life for CD patients Short Form 12

    Short Form 12 , higher means better,Short Form-12, 0-12;

    Time frame: 1 and 5 year after surgery

07

Study locations

1 of 1 sites recruiting
  • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
    Nanjing, Jiangsu 210002, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05658081
Lead sponsor
Jinling Hospital, China
Responsible party
Zhu Weiming (Jinling Hospital, Jinling Hospital, China) — Principal investigator
First posted
Dec 20, 2022
Start date
Dec 8, 2022
Primary completion
Dec 2024 (estimated)
Completion
Dec 2029 (estimated)
Last update
Dec 20, 2022

Study contacts

ming duan, M.D.
Contact
duanming1206@126.com
+86-025-80860036
Yi Li, Ph.D
principal investigator · Jinling Hospital,Nanjing, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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