AzTrials
AzTrials

Small Bowel ObstructionNGTUBE-OBSNCT06262815

The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction

An observational study of Small Bowel Obstruction and Frailty, run by Daniel Wilhelms at 8 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Small Bowel Obstruction, Frailty, Nasogastric Tube
What is being tested?
Nasogastric tube placement and Clinical Frailty Scale
Type of treatment
Surgery or procedure
How many people
400 participants
Where
8 sitesSweden
Study dates
1 Jan 2024to 31 May 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • Diagnosed small bowel obstruction
  • Age 18 or older

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Sweden8 sites
  • Sahlgrenska Universitetssjukhuset

    Gothenburg

  • Östra sjukhuset

    Gothenburg

  • Akutmottagningen US Östergötland

    Linköping, Östergötland County, 58185

  • Skånes Universitetssjukhus

    Lund

  • Skånes Universitetssjukhus

    Malmö

  • Lasarett i Motala

    Motala

  • Vrinnevisjukhuset

    Norrköping

  • Sundsvalls sjukhus

    Sundsvall

Other trials in Sweden

About this study

Official title: 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.

Being tested
Nasogastric tube placement, Clinical Frailty Scale
Keywords
Small bowel obstruction, nasogastric tube, pain, mortality, morbidity, frailty
Medical subject headings
Frailty, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasogastric tube placementProcedure or surgery

    Conventional nasogastric tube placement done for decompression of small bowel obstruction

  • Clinical Frailty ScaleDiagnostic test

    The scale described by Rockwood et al. categorizing patients \>65 years of age on a 9 item scale depending on the frailty.

Study groups in NCT06262815
Study groupRoleWhat they receive
Patients with nasogastric tube treatmentAdult patients with diagnosed small bowel obstruction in the Emergency Department for a nasogastric tube was placed
Receives: Procedure: Nasogastric tube placement
Patients without nasogastric tube treatmentAdult patients with diagnosed small bowel obstruction in the Emergency Department for no nasogastric tube was placed
Receives: Procedure: Nasogastric tube placement
Patients living with frailtySubgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of \>4.
Receives: Diagnostic Test: Clinical Frailty Scale
Patients not living with frailtySubgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of \<5.
Receives: Diagnostic Test: Clinical Frailty Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain at Emergency Department discharge

    self-reported Pain on a Numeric Rating Scale from 0 to 10 were higher is worse

    Measured: at Emergency Department Discharge, assessed up to 48 hours

Secondary outcomes (6)
  1. Nausea at Emergency Department discharge

    Nausea as self-reported by patients on a numeric rating scale from 0 to 10 were higher is worse

    Measured: at Emergency Department discharge, assessed up to 48 hours

  2. Hospital Length of Stay

    Duration of days spent in the hospital by patients with Small Bowel obstruction admitted from the Emergency Department

    Measured: Up to 90 days from inclusion

  3. Mortality

    Mortality of any cause

    Measured: up to 90 days from inclusion

  4. Admission for Small bowel obstruction

    Any admission to a hospital in Sweden with a primary discharge diagnosis of small bowel obstruction

    Measured: up to 365 days from inclusion in the study

  5. Emergency Surgery

    Any emergency operation

    Measured: up to 30 days from inclusion

  6. Emergency Department Length of Stay

    Length of stay, defined as the time from registration in the Emergency Department to discharge from the Emergency Department at the visit of inclusion.

    Measured: up to 7 days from inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start1 Jan 2024
  3. Primary completion31 May 2025
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06262815
Sponsor's protocol ID
2023-06806-01
Other IDs
2023
Acronym
NGTUBE-OBS
Status last verified
May 2025
First submitted
29 Dec 2023
Last updated
14 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Limited (providing full anonymization) data may be provided to other researchers

Publications

  • Elliott A, Taub N, Banerjee J, Aijaz F, Jones W, Teece L, van Oppen J, Conroy S. Does the Clinical Frailty Scale at Triage Predict Outcomes From Emergency Care for Older People? Ann Emerg Med. 2021 Jun;77(6):620-627. doi: 10.1016/j.annemergmed.2020.09.006. Epub 2020 Dec 13.

    PubMed 33328147
  • Rueegg M, Nissen SK, Brabrand M, Kaeppeli T, Dreher T, Carpenter CR, Bingisser R, Nickel CH. The clinical frailty scale predicts 1-year mortality in emergency department patients aged 65 years and older. Acad Emerg Med. 2022 May;29(5):572-580. doi: 10.1111/acem.14460. Epub 2022 Apr 23.

    PubMed 35138670
  • Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.

    PubMed 32336486
  • Ozturk E, van Iersel M, Stommel MM, Schoon Y, Ten Broek RR, van Goor H. Small bowel obstruction in the elderly: a plea for comprehensive acute geriatric care. World J Emerg Surg. 2018 Oct 20;13:48. doi: 10.1186/s13017-018-0208-z. eCollection 2018.

    PubMed 30377439
  • Koh A, Adiamah A, Chowdhury A, Mohiuddin MK, Bharathan B. Therapeutic Role of Water-Soluble Contrast Media in Adhesive Small Bowel Obstruction: a Systematic Review and Meta-Analysis. J Gastrointest Surg. 2020 Feb;24(2):473-483. doi: 10.1007/s11605-019-04341-7. Epub 2019 Aug 13.

    PubMed 31485900
  • Springer JE, Bailey JG, Davis PJ, Johnson PM. Management and outcomes of small bowel obstruction in older adult patients: a prospective cohort study. Can J Surg. 2014 Dec;57(6):379-84. doi: 10.1503/cjs.029513.

    PubMed 25421079
  • Hajibandeh S, Hajibandeh S, Panda N, Khan RMA, Bandyopadhyay SK, Dalmia S, Malik S, Huq Z, Mansour M. Operative versus non-operative management of adhesive small bowel obstruction: A systematic review and meta-analysis. Int J Surg. 2017 Sep;45:58-66. doi: 10.1016/j.ijsu.2017.07.073. Epub 2017 Jul 17.

    PubMed 28728984
  • Peacock O, Bassett MG, Kuryba A, Walker K, Davies E, Anderson I, Vohra RS; National Emergency Laparotomy Audit (NELA) Project Team. Thirty-day mortality in patients undergoing laparotomy for small bowel obstruction. Br J Surg. 2018 Jul;105(8):1006-1013. doi: 10.1002/bjs.10812. Epub 2018 Mar 30.

    PubMed 29603126
  • Kuo YW, Yen M, Fetzer S, Lee JD. Reducing the pain of nasogastric tube intubation with nebulized and atomized lidocaine: a systematic review and meta-analysis. J Pain Symptom Manage. 2010 Oct;40(4):613-20. doi: 10.1016/j.jpainsymman.2010.01.025. Epub 2010 Aug 3.

    PubMed 20678892
  • Morrison RS, Ahronheim JC, Morrison GR, Darling E, Baskin SA, Morris J, Choi C, Meier DE. Pain and discomfort associated with common hospital procedures and experiences. J Pain Symptom Manage. 1998 Feb;15(2):91-101.

    PubMed 9494307
  • Berman DJ, Ijaz H, Alkhunaizi M, Kulie PE, Vaziri K, Richards LM, Meltzer AC. Nasogastric decompression not associated with a reduction in surgery or bowel ischemia for acute small bowel obstruction. Am J Emerg Med. 2017 Dec;35(12):1919-1921. doi: 10.1016/j.ajem.2017.08.029. Epub 2017 Aug 15.

    PubMed 28912083
  • Edlich RF, Woods JA. Wangensteen's transformation of the treatment of intestinal obstruction from empiric craft to scientific discipline. J Emerg Med. 1997 Mar-Apr;15(2):235-41. doi: 10.1016/s0736-4679(96)00351-4.

    PubMed 9144067
  • Klingbeil KD, Wu JX, Osuna-Garcia A, Livingston EH. Management of small bowel obstruction and systematic review of treatment without nasogastric tube decompression. Surg Open Sci. 2022 Nov 7;12:62-67. doi: 10.1016/j.sopen.2022.10.002. eCollection 2023 Mar.

    PubMed 36992798
  • Shinohara K, Asaba Y, Ishida T, Maeta T, Suzuki M, Mizukami Y. Nonoperative management without nasogastric tube decompression for adhesive small bowel obstruction. Am J Surg. 2022 Jun;223(6):1179-1182. doi: 10.1016/j.amjsurg.2021.11.029. Epub 2021 Dec 2.

    PubMed 34872712
  • Ten Broek RPG, Krielen P, Di Saverio S, Coccolini F, Biffl WL, Ansaloni L, Velmahos GC, Sartelli M, Fraga GP, Kelly MD, Moore FA, Peitzman AB, Leppaniemi A, Moore EE, Jeekel J, Kluger Y, Sugrue M, Balogh ZJ, Bendinelli C, Civil I, Coimbra R, De Moya M, Ferrada P, Inaba K, Ivatury R, Latifi R, Kashuk JL, Kirkpatrick AW, Maier R, Rizoli S, Sakakushev B, Scalea T, Soreide K, Weber D, Wani I, Abu-Zidan FM, De'Angelis N, Piscioneri F, Galante JM, Catena F, van Goor H. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2017 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2018 Jun 19;13:24. doi: 10.1186/s13017-018-0185-2. eCollection 2018.

    PubMed 29946347

Questions about this trial

What is this clinical trial studying?

An observational study of Small Bowel Obstruction and Frailty, run by Daniel Wilhelms at 8 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain at Emergency Department discharge (time frame: at Emergency Department Discharge, assessed up to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06262815, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in