Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
2026년 7월 6일 업데이트: Xiaolei Wang, Shanghai 10th People's Hospital
This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD).
It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025.
Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery.
The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively.
Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat.
Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent.
Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.
연구 개요
상태
모병
상세 설명
This study is a retrospective cohort study aiming to compare the efficacy of different biologics in preventing endoscopic recurrence after surgery for Crohn's disease (CD).
It plans to include 198 adult CD patients who underwent intestinal resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025.
Patients will be divided into an anti-TNF group (e.g., infliximab, adalimumab) and a non-anti-TNF group (e.g., vedolizumab, ustekinumab) based on the biologic agent used within six weeks post-surgery.
The primary outcome is the rate of endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively.
Secondary outcomes include the rate of severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and pathological changes in the intestinal tissue and mesenteric fat.
Subgroup analyses will be conducted to explore differences in efficacy across varying levels of recurrence risk and resection extent.
Through retrospective data collection and statistical analyses including multivariate regression and survival analysis, this study aims to provide real-world evidence to optimize the selection of postoperative biologic therapy in clinical practice.
연구 유형
관찰
등록 (추정된)
198
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 201505
- 모병
- The Tenth People's Hospital of Shanghai
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연락하다:
- Xiaolei Wang, MD, PhD
- 전화번호: 13817267967
- 이메일: wangxiaolei@tongji.edu.cn
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연락하다:
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
This retrospective cohort study will include adult patients with Crohn's disease who underwent CD-related intestinal resection at Shanghai Tenth People's Hospital between January 1, 2015 and April 1, 2025.
Eligible patients initiated postoperative prophylactic biologic therapy within 6 weeks after surgery and had available postoperative follow-up data, including endoscopic assessment within 6 to 12 months after surgery or other clinical data for recurrence evaluation.
Patients will be grouped according to the type of postoperative prophylactic biologic therapy, including anti-TNF biologics and non-anti-TNF biologics.
설명
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.
- Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.
- Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.
- Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.
- Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.
Exclusion Criteria:
- Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy.
- Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy.
- No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment.
- Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate.
- Other conditions considered by the investigators to be inappropriate for inclusion.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Postoperative anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic anti-TNF biologic therapy within 6 weeks after surgery, including infliximab or adalimumab.
All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
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Infliximab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen was 5 mg/kg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.
Adalimumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen was 160 mg subcutaneously at week 0, 80 mg at week 2, and 40 mg every 2 weeks from week 4 onward.
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Postoperative non-anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic non-anti-TNF biologic therapy within 6 weeks after surgery, including vedolizumab or ustekinumab.
All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
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Vedolizumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen was 300 mg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.
Ustekinumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen included a weight-based intravenous induction dose, followed by 90 mg subcutaneously every 8 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Endoscopic recurrence rate
기간: 6 to 12 months after surgery
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The proportion of patients with endoscopic recurrence, defined as a Rutgeerts score ≥ i2 on ileocolonoscopy performed 6 to 12 months after CD-related intestinal resection.
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6 to 12 months after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Severe endoscopic recurrence rate
기간: 6 to 12 months after surgery
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The proportion of patients with severe endoscopic recurrence, defined as a Rutgeerts score ≥ i3 on postoperative ileocolonoscopy.
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6 to 12 months after surgery
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Clinical recurrence rate
기간: Up to 5 years after surgery
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The proportion of patients with clinical recurrence, defined as worsening Crohn's disease-related symptoms supported by endoscopic, radiologic, ultrasonographic, laboratory, or medical record evidence, or requiring treatment escalation, hospitalization, or reoperation due to Crohn's disease activity.
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Up to 5 years after surgery
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Long-term endoscopic recurrence rate
기간: 3 and 5 years after surgery
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The proportion of patients with endoscopic recurrence during long-term follow-up, defined as a Rutgeerts score ≥ i2 on follow-up endoscopy.
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3 and 5 years after surgery
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Crohn's disease-related rehospitalization rate
기간: Up to 5 years after surgery
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The proportion of patients requiring rehospitalization due to Crohn's disease activity, complications, or treatment-related problems during follow-up.
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Up to 5 years after surgery
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Crohn's disease-related reoperation rate
기간: Up to 5 years after surgery
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The proportion of patients requiring repeat abdominal surgery due to Crohn's disease recurrence or related complications during follow-up.
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Up to 5 years after surgery
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Drug persistence
기간: Up to 5 years after treatment initiation
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Time from initiation of postoperative prophylactic biologic therapy to treatment discontinuation, switch to another biologic or immunomodulator, or discontinuation due to intolerance or adverse events.
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Up to 5 years after treatment initiation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 16일
기본 완료 (추정된)
2026년 9월 30일
연구 완료 (추정된)
2026년 10월 31일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 6일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SHSY-IEC-6.0/26K14/P01
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아니요
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