The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial (SBO-TUBE)
2026年6月8日 更新者：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
調査の概要
研究の種類
介入
入学 (推定)
1000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jens Wretborn, Associate Professor
- 電話番号：+46101030000
- メール：jens.wretborn@liu.se
研究連絡先のバックアップ
- 名前：Erika Johannesson, MSc
- 電話番号：+46101030000
研究場所
-
-
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Linköping、スウェーデン、58561
- 募集
- Linköping University Hospital
-
コンタクト：
- Jens Wretborn, Associate Professor
- 電話番号：+46101030000
- メール：jens.wretborn@liu.se
-
Motala、スウェーデン、59135
- 募集
- Motala Lasarett
-
コンタクト：
- Jens Wretborn, Associate Professor
- 電話番号：+46101030000
- メール：jens.wretborn@liu.se
-
Värnamo、スウェーデン、33156
- 募集
- Värnamo Lasarett
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コンタクト：
- Jenny Gustavsson, MD
- 電話番号：+46102410000
- メール：jenny.gustavsson@rjl.se
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副調査官：
- Amanda Tyrsing, MD
-
副調査官：
- Kaj Li, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Nasogastric Tube
This arm receives a nasogastric tube.
Other management according to local guidelines.
|
The placement of a nasogastric tube from the nares to gastric ventricle.
|
|
介入なし：No Nasogastric Tube
Nasogastric tube is deferred.
Other management according to local guidelines
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
時間枠：From enrollment until 30 days or hospital discharge
|
Pulmonary complications, any of:
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surgery
時間枠：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
時間枠：From enrollment until 365 days
|
Death from any cause
|
From enrollment until 365 days
|
|
Time to functional recovery
時間枠：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:
|
From enrollment until 30 days or hospital discharge, whichever comes first
|
|
Bowel perforation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment until 365 days
|
Any readmission to hospital for small bowel obstruction
|
From enrollment until 365 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrent Small Bowel Obstruction
時間枠：From inclusion until 365 days
|
Admission for small bowel obstruction
|
From inclusion until 365 days
|
|
Health-related quality of life
時間枠：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
時間枠：From inclusion until 30 days or hospital discharge, whichever comes first
|
From inclusion until 30 days or hospital discharge, whichever comes first
|
|
|
Nausea
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：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
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月27日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。