- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07824180
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care (AUD)
From Guidelines to Real-world Practice: a Pragmatic Before and After Study on the Treatment of Acute Uncomplicated Diverticulitis (AUD) Based on a Risk Factor Driven Treatment Algorithm (AUD Management Algorithm Protocol)
Acute uncomplicated diverticulitis is often treated with antibiotics, although current evidence shows that antibiotics are not always necessary. This study will evaluate whether a more standardized approach to treatment can reduce unnecessary antibiotic use without increasing the risk of treatment failure.
The study will compare patients treated before and after the new treatment approach is introduced in participating Swiss hospitals. Information on treatment, hospital admissions, complications and recurrence of diverticulitis will be collected. Patients will be followed for up to 24 months.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dimitri Christoforidis, MD
- 이메일: Dimitrios.Christoforidis@eoc.ch
연구 연락처 백업
- 이름: Elena Porro, Msc
- 전화번호: 0041918117038
- 이메일: ricerca.chirurgiaorl@eoc.ch
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years or older
- CT-confirmirmed acute uncomplicated diverticulitis of the left colon
- Ability to provide informed consent for participants in the prospective phase
Exclusion Criteria:
- Complicated acute diverticulitis, defined as diverticulitis with abscess, perforation (free air), fistula, or distant free fluid
Diverticulitis of the right or transverse colon
-.Alternative diagnosis explaining the participant's symptoms
- No possibility of completing the 90-day follow-up
- Inability to provide informed consent for the prospective phase
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Antibiotic Treatment
Participants with acute uncomplicated diverticulitis who receive antibiotic treatment according to the standardized treatment approach.
|
A standardized treatment approach based on clinical findings, laboratory results, comorbidities, immunosuppression status, and CT findings is introduced to support treatment decisions in patients with acute uncomplicated diverticulitis.
Depending on these factors, patients may be managed with or without antibiotics.
|
|
다른: No Antibiotic Treatment Arm Description:
Participants with acute uncomplicated diverticulitis who are managed without antibiotics according to the standardized treatment approach.
|
A standardized treatment approach based on clinical findings, laboratory results, comorbidities, immunosuppression status, and CT findings is introduced to support treatment decisions in patients with acute uncomplicated diverticulitis.
Depending on these factors, patients may be managed with or without antibiotics.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment failure
기간: Within 90 days after diagnosis
|
Treatment failure is defined as a composite outcome including progression to complicated diverticulitis requiring percutaneous abscess drainage or surgery, delayed initiation of antibiotics after initial management without antibiotics, or unplanned hospital admission following initial outpatient treatment.
|
Within 90 days after diagnosis
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Antibiotic use
기간: Within 90 days after diagnosis
|
Proportion of participants receiving antibiotics
|
Within 90 days after diagnosis
|
|
Adherence to the standardized treatment approach
기간: At the initial treatment decision
|
Proportion of participants whose management is consistent with the standardized treatment approach.
|
At the initial treatment decision
|
|
Outpatient versus inpatient management
기간: At the initial treatment decision
|
roportion of participants initially managed as outpatients versus inpatients.
|
At the initial treatment decision
|
|
Hospital admission
기간: Within 30 days after diagnosis
|
Proportion of participants readmitted to hospital.
|
Within 30 days after diagnosis
|
|
Recurrence of diverticulitis
기간: Within 24 months after diagnosis
|
Proportion of participants experiencing recurrence of diverticulitis.
|
Within 24 months after diagnosis
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dimitri Christoforidis, MD, EOC
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .