The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction (NGTUBE-OBS)

February 13, 2024 updated by: Daniel Wilhelms

The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction in Adult Patients in the Emergency Department; an Observational Multicenter Study

Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.

Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.

To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Göteborg, Sweden
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
          • Nina Bardhi, MD
      • Göteborg, Sweden
        • Recruiting
        • Östra sjukhuset
        • Contact:
          • Mathias Jerkfelt, MD
      • Lund, Sweden
        • Active, not recruiting
        • Skanes universitetssjukhus
      • Malmö, Sweden
        • Active, not recruiting
        • Skanes universitetssjukhus
      • Motala, Sweden
      • Norrköping, Sweden
        • Recruiting
        • Vrinnevisjukhuset
        • Contact:
          • Sigrid Wallden, MD
      • Sundsvall, Sweden
        • Recruiting
        • Sundsvalls Sjukhus
        • Contact:
          • Robert Schytzer, MD
    • Östergötland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients visiting any of the following Emergency Departments in Sweden:

  • Linköping University Hospital
  • Motala Lasarett
  • Vrinnevisjukhuset Norrköping
  • Sundvalls Lasarett
  • Skåne University Hospital Malmö
  • Skåne University Hospital Lund
  • Sahlgrenska University Hospital Sahlgrenska
  • Sahlgrenska University Hospital Östra

Description

Inclusion Criteria:

  • Diagnosed small bowel obstruction
  • Age 18 or older

Exclusion Criteria:

  • Abdominal surgery within 7 days
  • Not able to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with nasogastric tube treatment
Adult patients with diagnosed small bowel obstruction in the Emergency Department for a nasogastric tube was placed
Procedure: Nasogastric tube placement
Conventional nasogastric tube placement done for decompression of small bowel obstruction
Patients without nasogastric tube treatment
Adult patients with diagnosed small bowel obstruction in the Emergency Department for no nasogastric tube was placed
Procedure: Nasogastric tube placement
Conventional nasogastric tube placement done for decompression of small bowel obstruction
Patients living with frailty
Subgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of >4.
Diagnostic test: Clinical Frailty Scale
The scale described by Rockwood et al. categorizing patients >65 years of age on a 9 item scale depending on the frailty.
Patients not living with frailty
Subgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of <5.
Diagnostic test: Clinical Frailty Scale
The scale described by Rockwood et al. categorizing patients >65 years of age on a 9 item scale depending on the frailty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at Emergency Department discharge
Time Frame: at Emergency Department Discharge, assessed up to 48 hours
self-reported Pain on a Numeric Rating Scale from 0 to 10 were higher is worse
at Emergency Department Discharge, assessed up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea at Emergency Department discharge
Time Frame: at Emergency Department discharge, assessed up to 48 hours
Nausea as self-reported by patients on a numeric rating scale from 0 to 10 were higher is worse
at Emergency Department discharge, assessed up to 48 hours
Hospital Length of Stay
Time Frame: Up to 90 days from inclusion
Duration of days spent in the hospital by patients with Small Bowel obstruction admitted from the Emergency Department
Up to 90 days from inclusion
Mortality
Time Frame: up to 90 days from inclusion
Mortality of any cause
up to 90 days from inclusion
Admission for Small bowel obstruction
Time Frame: up to 365 days from inclusion in the study
Any admission to a hospital in Sweden with a primary discharge diagnosis of small bowel obstruction
up to 365 days from inclusion in the study
Emergency Surgery
Time Frame: up to 30 days from inclusion
Any emergency operation
up to 30 days from inclusion
Emergency Department Length of Stay
Time Frame: up to 7 days from inclusion
Length of stay, defined as the time from registration in the Emergency Department to discharge from the Emergency Department at the visit of inclusion.
up to 7 days from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Wilhelms

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Daniel B Wilhelms, PhD, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-06806-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Limited (providing full anonymization) data may be provided to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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