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The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial (SBO-TUBE)

2026년 6월 8일 업데이트: Daniel Wilhelms, University Hospital, Linkoeping

The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Randomized Controlled Trial

Background: Small bowel obstruction (SBO) is a surgical emergency where the normal continuous bowel movements are hindered and approximately 8000-9000 patients visit the emergency department every year in Sweden due to SBO. A minority of these have evidence of intestinal injury, warranting emergency surgery, while the majority (70-90%) will have an initial plan for non-operative management with a nasogastric tube (NGT), placed to alleviate gastric pressure, reduce pain and prevent complications like aspiration pneumonia. The effectiveness of NGT in patients with SBO to prevent complications is unclear, with current data from observational data indicating increased risk of pneumonia in patients treated with NGT. Objective: To assess whether deferring the placement of a NGT in subjects with small bowel obstruction and planned for non-operative management leads to lower rates of respiratory complication compared to placing an NGT. Methods: This will be a randomized, controlled, open-label, multicenter study of patients with SBO and an initial plan for non-operative management. Patients will be randomized in a 1:1 ratio to not receive an NGT (intervention) or receive an NGT (control) and monitored regularly until the SBO resolves spontaneously or through surgery, whichever comes first. The primary outcome will be a composite of pulmonary complications and treatment in a high dependency unit, analyzed as a superiority study with an intention-to-treat framework with secondary per-protocol and non-inferiority analysis. The trial will recruit 1000 patients. Secondary analysis includes health-economy, qualitative interviews, and long term (1 year) follow up. Discussion: The current management of NGT in SBO is based on clinical and guideline-based recommendations with limited supporting data. Available data, albeit observational with risk for selection bias, indicates increased risk of complications. This equipoise warrants further investigation to understand the true benefit of NGT in SBO. This study will provide high quality evidence of the ability of a NGT to prevent complications in SBO through its randomized, prospective design

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

1000

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Jens Wretborn, Associate Professor
  • 전화번호: +46101030000
  • 이메일: jens.wretborn@liu.se

연구 연락처 백업

  • 이름: Erika Johannesson, MSc
  • 전화번호: +46101030000

연구 장소

  • 스웨덴
      • Linköping, 스웨덴, 58561
        • 모병
        • Linköping University Hospital
        • 연락하다:
      • Motala, 스웨덴, 59135
        • 모병
        • Motala Lasarett
        • 연락하다:
      • Värnamo, 스웨덴, 33156
        • 모병
        • Värnamo Lasarett
        • 연락하다:
        • 부수사관:
          • Amanda Tyrsing, MD
        • 부수사관:
          • Kaj Li, MD

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:

  • Small bowel obstruction diagnosed on Computer Tomography

Exclusion Criteria:

  • Nasogastric Tube already places
  • Amyotrophic lateral sclerosis
  • Cerebral palsy
  • Dementia
  • Parkinson's disease
  • Multiple Sclerosis
  • Previous stroke with documented persistent dysphagia
  • Planned for urgent surgery
  • Acute Massive Gastric Dilatation
  • Gastric outlet obstruction
  • Fundoplicatio/Inability to vomit
  • Signs of pneumonia/pneumonitis on initial diagnostic CT

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Nasogastric Tube
This arm receives a nasogastric tube. Other management according to local guidelines.
절차: Nasogastric tube placement
The placement of a nasogastric tube from the nares to gastric ventricle.
간섭 없음: No Nasogastric Tube
Nasogastric tube is deferred. Other management according to local guidelines

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
기간: From enrollment until 30 days or hospital discharge

Pulmonary complications, any of:

  • Respiratory infection - treatment with antibiotics supported by suggestive findings on x-ray and/or laboratory findings
  • Respiratory failure - new pulse-oximetry values below 90% or an increased need for supplemental oxygen for an oxygen saturation above 90%, measured by pulse-oximetry or blood gases.
  • Pleural effusion - based on x-ray findings
  • Atelectasis - based on x-ray findings
  • Pneumothorax - based on x-ray findings
  • Bronchospasm - documented wheezing or increased effort breathing
  • Aspiration pneumonitis - treatment with antibiotics supported by suggestive findings on x-ray and/or laboratory findings and a clinical correlation to an event of vomiting/dysphagia High dependency unit or Intensive care unit

This study will use the definitions of pulmonary complications defined by Jammer et al:

Individual components of the composite endpoint will be reported and analysed separately as secondary endpoints.
From enrollment until 30 days or hospital discharge

2차 결과 측정

결과 측정
측정값 설명
기간
Surgery
기간: From enrollment until 30 days or hospital discharge, whichever comes first
Requiring surgery for their small bowel obstruction
From enrollment until 30 days or hospital discharge, whichever comes first
Death
기간: From enrollment until 365 days
Death from any cause
From enrollment until 365 days
Time to functional recovery
기간: From enrollment until 30 days or hospital discharge, whichever comes first

Time to functional recovery is seen as a more objective outcome compared to hospital length of stay, which may be influenced by other factors, not related to the disease. Functional recovery is a composite of the following components:

  • Independently mobile at preoperative level
  • Sufficient pain control with oral medications only
  • Ability to maintain necessary caloric intake with parenteral nutrition of fluids
  • No intravenous fluid administration
  • No clinical signs of infection
From enrollment until 30 days or hospital discharge, whichever comes first
Bowel perforation
기간: From enrollment until 30 days or hospital discharge, whichever comes first
As a finding, or complication, during surgery
From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection
기간: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection during surgery measured in cm.
From enrollment until 30 days or hospital discharge, whichever comes first
Hospital Length of Stay
기간: Enrollment until 30 days or hospital discharge, whichever comes first
Length of stay in hospitals measured both as when the subject is ready to leave the hospital and when the subject actually leaves hospital
Enrollment until 30 days or hospital discharge, whichever comes first
Emergency Department Length of Stay
기간: From emergency department registration until 2 days or emergency department discharge, whichever comes first.
The duration the research subject stays in the Emergency Department
From emergency department registration until 2 days or emergency department discharge, whichever comes first.
Time to resolved small bowel obstruction
기간: From enrollment until 30 days or hospital discharge, whichever comes first
Time to resolvement of obstruction, defined as either; Water soluable contrast passing to the colon, or both ability to pass gas and ability for oral intake
From enrollment until 30 days or hospital discharge, whichever comes first
Readmission for small bowel obstruction
기간: From enrollment until 365 days
Any readmission to hospital for small bowel obstruction
From enrollment until 365 days

기타 결과 측정

결과 측정
측정값 설명
기간
Recurrent Small Bowel Obstruction
기간: From inclusion until 365 days
Admission for small bowel obstruction
From inclusion until 365 days
Health-related quality of life
기간: Up to 30 days after hospital discharge
Measured by the EQ-5D-5L tool
Up to 30 days after hospital discharge
Number of required morphine-equivalents
기간: From inclusion until 30 days or hospital discharge, whichever comes first
From inclusion until 30 days or hospital discharge, whichever comes first
Nausea
기간: From enrollment until 30 days or hospital admission, whichever comes first
Nausea, measured on a numeric rating scale from 0 to 10
From enrollment until 30 days or hospital admission, whichever comes first
Pain from Small bowel obstruction
기간: From enrollment until 30 days or hospital admission, whichever comes first
Pain, measure on a numeric rating scale from 0-10
From enrollment until 30 days or hospital admission, whichever comes first
Pain from insertion of nasogastric tube
기간: From enrollment until 2 days or emergency department discharge, whichever comes first
Patient experience pain on a NRS 0-10 scale
From enrollment until 2 days or emergency department discharge, whichever comes first
Discomfort from nasogastric tube
기간: From enrollment until 30 days or hospital admission, whichever comes first
Patient-experience discomfort, rated on NRS (0-10) scale
From enrollment until 30 days or hospital admission, whichever comes first

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Linkoeping

협력자

Linkoeping University
Region Jönköping County

수사관

  • 수석 연구원: Jens Wretborn, Associate Professor, Clinical Department of Emergency Medicine in Linköping, Region Östergötland, Linköping, Sweden; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

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 5월 27일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 8일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-00330-01

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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