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Multimodal Prehabilitation for Tumor-Related Bowel Obstruction

2026년 8월 14일 업데이트: The Affiliated Hospital of Qingdao University

Effect of Multimodal Prehabilitation on Clinical Outcomes in Patients With Tumor-Related Bowel Obstruction: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to establish a multimodal prehabilitation protocol suitable for patients with tumor-related bowel obstruction during the perioperative period, and to explore its safety and efficacy; to evaluate the impact of this protocol on short-term and long-term clinical outcomes and recovery indicators.The participants will be divided into two groups. The experimental group will receive an integrated program of preoperative multi-modal pre-rehabilitation intervention combined with postoperative immune nutrition support; the control group will receive traditional perioperative management for intestinal obstruction.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

394

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Shandong
      • Qingdao, Shandong, 중국, 266003
        • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong 266000

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

설명

Inclusion Criteria:

  1. Pathologically/cytologically confirmed malignant tumor (including digestive system and gynecological origin tumors); or imaging data suggesting tumor space-occupying lesions combined with multiple metastatic foci;
  2. Diagnosis of bowel obstruction (complete or incomplete) confirmed by medical history, symptoms, signs, and imaging (abdominal plain film/CT), and after MDT decision-making, no emergency surgery is required, short-term conservative treatment has potential for remission, and the expected interval from conservative treatment period to planned surgery is ≥7 days;
  3. Age between 18 and 85 years;
  4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  5. Expected survival ≥12 weeks;
  6. Patients and their families have full understanding of disease progression and prognosis, accept conservative treatment, and are fully mentally prepared for the high incidence of severe surgical complications; they can understand and voluntarily sign the written informed consent form, which must be signed before performing study-specified procedures.

Exclusion Criteria:

  1. Presence of acute, life-threatening complications such as strangulated bowel obstruction, electrolyte disturbances, or sepsis;
  2. Presence of intestinal necrosis, perforation, bleeding, or other conditions requiring immediate surgical treatment;
  3. ASA grade >IV, severe cardiac insufficiency (preoperative LVEF <30% or NYHA grade IV), severe hepatic dysfunction (Child-Pugh grade C), and renal dysfunction (requiring CRRT);
  4. History of cerebral hemorrhage, cerebral infarction, TIA, or presence of central nervous system disease, psychiatric disease, or bedridden status within 6 months before informed consent that precludes completion of multimodal intervention;
  5. Long-term or high-dose use of immunosuppressants or glucocorticoids within 1 month before enrollment;
  6. Presence of language communication barriers, unable to independently or with family assistance understand and complete intervention and assessment;
  7. Patients currently participating in other drug or clinical interventional trials.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Experimental group
The experimental group: on the basis of the standard six-step treatment model (decompression, adding nutrition, suppressing digestive fluid secretion, hormone, diuresis, and exercise and promoting intestinal peristalsis), a goal-directed multimodal prehabilitation intervention lasting 5 to 7 days will be superimposed and implemented during the preoperative hospitalization period, with contents including immunonutritional support, progressive physical training, and structured psychological counseling. Postoperatively, the standard perioperative Enhanced Recovery After Surgery (ERAS) protocol will be continued to be executed, and immunonutritional treatment will be strengthened.
행동: ERAS 프로토콜
핵심 내용은 증거 기반 의학적 소견을 바탕으로 수술 전후 기간 동안 수행되는 일련의 최적화된 조치를 채택하여 환자의 생리적, 심리적 스트레스를 줄이고 회복을 가속화하는 것입니다.
행동: Multimodal prehabilitation program
Multimodal prehabilitation program adopts a planned, structured, repeatable, and purposeful approach, encompassing exercise, nutrition, and psychological factors.
행동: Standard six-step treatment
The standard six-step treatment protocol refers to: decompression, nutritional supplementation, suppression of digestive fluid secretion, hormone therapy, diuresis, exercise, and promotion of intestinal peristalsis.
활성 비교기: Control group
The control group: preoperatively, only the standard six-step treatment protocol will be received. Postoperatively, standard Enhanced Recovery After Surgery (ERAS) protocol will be followed for perioperative management.
행동: ERAS 프로토콜
핵심 내용은 증거 기반 의학적 소견을 바탕으로 수술 전후 기간 동안 수행되는 일련의 최적화된 조치를 채택하여 환자의 생리적, 심리적 스트레스를 줄이고 회복을 가속화하는 것입니다.
행동: Standard six-step treatment
The standard six-step treatment protocol refers to: decompression, nutritional supplementation, suppression of digestive fluid secretion, hormone therapy, diuresis, exercise, and promotion of intestinal peristalsis.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Comprehensive Complication Index (CCI)
기간: Postoperative (≤30 days after surgery)
Used to quantify the cumulative complication burden of individual patients. The calculation premise is to first grade each complication occurring within 30 days postoperatively according to the Clavien-Dindo Classification (CDC), then accumulate the corresponding "weight (wC)" of each complication, substitute into the formula for square root calculation and divide by 2, ultimately obtaining a continuous score from 0-100 (0 = no complications, 100 = death).
Postoperative (≤30 days after surgery)

2차 결과 측정

결과 측정
측정값 설명
기간
The 30-day postoperative mortality
기간: POD 30（30 days after surgery）
30-day postoperative mortality defined as death within 30 days postoperatively or in-hospital death during hospitalization.
POD 30（30 days after surgery）
Complication occurrence during the preoperative observation and intervention period, remission rate of bowel obstruction after conservative treatment
기간: Baseline (T0), Post-intervention (At least 7 days),
The complication occurrence defined as complications diagnosed after admission and occurring before surgery
Baseline (T0), Post-intervention (At least 7 days),
Preoperative and 30-day postoperative quality of life scores
기간: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire assesses 15 dimensions of HRQoL, including physical, psychological, and social functions.
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Nutritional status-hemoglobin, albumin, prealbumin levels
기간: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
Hemoglobin, albumin, and prealbumin levels are used to assess nutritional status.
Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, 30
Immune status - CRP, NLR, CD4/CD8
기간: Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
Inflammatory indicators, including C-reactive protein (CRP), the neutrophil-to-lymphocyte ratio (NLR), and CD4/CD8, can reflect the level of inflammation.
Baseline (T0), Post-intervention (at least 7 days), and POD 1, 3, 5, and 30.
Functional capacity
기간: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
preoperative and 30-day postoperative 6-Minute Walk Test
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
postoperative ICU stay
기간: POD 30（30 days after surgery）
Duration of postoperative ICU stay (hours), defined as time to transfer to icu for treatment after surgery.
POD 30（30 days after surgery）
The incidence and severity of complications within 30 days after the surgery
기간: POD 30（30 days after surgery）
Incidence and severity of complications within 30 days postoperatively (especially infectious complications) (all complications will be scored according to the Clavien-Dindo classification system)
POD 30（30 days after surgery）
Preoperative and 30-day postoperative psychological states
기간: Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.
Baseline (T0), Post-intervention (at least 7 days), and POD 30（30 days after surgery）
mechanical ventilation time
기간: POD 30（30 days after surgery）
POD 30（30 days after surgery）
postoperative pain severity
기간: POD 30（30 days after surgery）
The severity of postoperative pain is evaluated using the Visual Analog Scale for pain (VAS, 0 = no pain, 10 = most severe pain).
POD 30（30 days after surgery）
total hospitalization costs
기간: POD 30（30 days after surgery）
POD 30（30 days after surgery）

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Affiliated Hospital of Qingdao University

협력자

Peking University People's Hospital
Fudan University
Fujian Medical University Union Hospital
The Second Hospital of Shandong University
Yantai Yuhuangding Hospital
Xinjiang Medical University
Weifang People's Hospital
Rizhao People's Hospital
The First School of Clinical Medicine of Binzhou Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2028년 7월 1일

연구 완료 (추정된)

2028년 8월 1일

연구 등록 날짜

최초 제출

2026년 8월 11일

QC 기준을 충족하는 최초 제출

2026년 8월 14일

처음 게시됨 (실제)

2026년 8월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 14일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GISSG-PREHAB2602

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

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