Crohn DiseaseNCT05658081
Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
A study testing Kono-S group and Side-to-side group in people with Crohn Disease and Recurrence, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Crohn Disease, Recurrence
- What is being tested?
- Kono-S group and Side-to-side group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2022to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with Crohn's disease needing bowel resection and anastomosis;
- ileocolic anastomosis；
- written consent acquired
Who cannot join
- patients underwent enterostomy;
- small bowel anastomosis;
- anticipating other trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Weiming Zhu, PhD, 86-25-80863736, juwiming@126.com
About this study
Official 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
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.
- Conditions
- Crohn Disease, Recurrence
- Being tested
- Kono-S group, Side-to-side group
- Medical subject headings
- Crohn Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kono-S groupProcedure or surgery
patients in this arm will receive stapled Kono-S anastomosis after bowel resection
Side-to-side groupProcedure or surgery
patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection
| Study group | Role | What they receive |
|---|---|---|
| Kono-S group | Experimental | patients in this arm will receive stapled Kono-S anastomosis after bowel resection Receives: Procedure: Kono-S group |
| Side-to-side group | Other | patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection Receives: Procedure: Side-to-side group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the endoscopic recurrence rate at 1 year after surgery
the endoscopic recurrence rate at 1 year after surgery
Measured: at 1 year after surgery(6-18month)
Secondary outcomes (5)
the clinical recurrence rate at 1 and 5 year after surgery
the clinical recurrence rate at 1 and 5 year after surgery
Measured: 1 and 5 year after surgery
the surgical recurrence rate at 1 and 5 year after surgery
the surgical recurrence rate at 1 and 5 year after surgery
Measured: 1 and 5 year after surgery
the endoscopic recurrence rate at 1 year after surgery
the endoscopic recurrence rate at 1 year after surgery
Measured: 1 and 5 year after surgery
quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)
IBDQ ， higher means better，IBDQ，7-224；
Measured: 1 and 5 year after surgery
quality of life for CD patients Short Form 12
Short Form 12 ， higher means better，Short Form-12， 0-12；
Measured: 1 and 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start8 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
- Investigators
- Yi Li, Ph.D, Principal investigator, Jinling Hospital，Nanjing， China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658081
- Sponsor's protocol ID
- jinlingH20221202
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05658081
- Acronym / sponsor ID
- jinlingH20221202
- Conditions
- Crohn Disease, Recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kono-S group | Experimental | Procedure: Kono-S grouppatients in this arm will receive stapled Kono-S anastomosis after bowel resection |
| Side-to-side group | Other | Procedure: Side-to-side grouppatients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with Crohn's disease needing bowel resection and anastomosis;
- ileocolic anastomosis；
- written consent acquired
Key exclusion criteria (3 listed)
- patients underwent enterostomy;
- small bowel anastomosis;
- anticipating other trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kono-S grouppatients in this arm will receive stapled Kono-S anastomosis after bowel resection | Procedure or surgery | Kono-S group |
| Side-to-side grouppatients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection | Procedure or surgery | Side-to-side group |
Primary outcome
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
5 secondary outcomes
the clinical 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
Time frame: 1 and 5 year after surgery
the endoscopic recurrence rate at 1 year after surgery
Time frame: 1 and 5 year after surgery
quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)
Time frame: 1 and 5 year after surgery
quality of life for CD patients Short Form 12
Time frame: 1 and 5 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Li, Ph.D principal investigator
Jinling Hospital，Nanjing， China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kono-S group and Side-to-side group in people with Crohn Disease and Recurrence, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ming duan, M.D. (+86-025-80860036, duanming1206@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the endoscopic recurrence rate at 1 year after surgery (time frame: at 1 year after surgery(6-18month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022; AzTrials last refreshed its copy on 2 Nov 2026.