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NCT Number: NCT05658081

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

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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Key information

Conditions

Crohn Disease Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location status: Recruiting

Location contact

Weiming Zhu, PhD

CONTACT

[email protected]

86-25-80863736

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Kono-S group

Procedure

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

Side-to-side group

Procedure

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

Primary outcomes

  1. the endoscopic recurrence rate at 1 year after surgery

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

    the endoscopic recurrence rate at 1 year after surgery

Secondary outcomes

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

    Time frame: 1 and 5 year after surgery

    the clinical recurrence rate at 1 and 5 year after surgery

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

    Time frame: 1 and 5 year after surgery

    the surgical recurrence rate at 1 and 5 year after surgery

  3. the endoscopic recurrence rate at 1 year after surgery

    Time frame: 1 and 5 year after surgery

    the endoscopic recurrence rate at 1 year after surgery

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

    Time frame: 1 and 5 year after surgery

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

  5. quality of life for CD patients Short Form 12

    Time frame: 1 and 5 year after surgery

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

Study contacts

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

ming duan, M.D.

CONTACT

[email protected]

+86-025-80860036

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Stapled Antimesenteric Functional End-to-end Anastomosis (Kono-S) Versus Stapled Antimesenteric Isoperistaltic Side-to-side Anastomosis for the Postoperative Recurrence of Crohn's Disease: a Randomized Control Trial Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Dec 20, 2022
Registry last updated
Dec 20, 2022

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.

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