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

NCT06262815 | Active Not Recruiting

• 1 other identifier: 2023-06806-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Small Bowel Obstruction; Frailty; Nasogastric Tube

Keywords

Small bowel obstruction; nasogastric tube; pain; mortality; morbidity; frailty

Outcome Measures

Primary Outcomes (1)

• Pain at Emergency Department discharge

  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 Outcomes (6)

• Nausea at Emergency Department discharge

  at Emergency Department discharge, assessed up to 48 hours

• Hospital Length of Stay

  Up to 90 days from inclusion

• Mortality

  up to 90 days from inclusion

• Admission for Small bowel obstruction

  up to 365 days from inclusion in the study

• Emergency Surgery

  up to 30 days from inclusion

Study Arms (4)

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

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

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

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

Interventions

Nasogastric tube placement PROCEDURE

Conventional nasogastric tube placement done for decompression of small bowel obstruction

Patients with nasogastric tube treatment; Patients without nasogastric tube treatment

Clinical Frailty Scale DIAGNOSTIC_TEST

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

Patients living with frailty; Patients not living with frailty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosed small bowel obstruction
• Age 18 or older

You may not qualify if:

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

Sponsors & Collaborators

• Daniel Wilhelms: lead
• Linkoeping University: collaborator

Study Sites (8)

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Östra sjukhuset

Gothenburg, Sweden

Location

Skånes Universitetssjukhus

Lund, Sweden

Location

Skånes Universitetssjukhus

Malmo, Sweden

Location

Lasarett i Motala

Motala, Sweden

Location

Vrinnevisjukhuset

Norrköping, Sweden

Location

Sundsvalls sjukhus

Sundsvall, Sweden

Location

Akutmottagningen US Östergötland

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (16)

• 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.

  PMID: 33328147 BACKGROUND

• 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.

  PMID: 35138670 BACKGROUND

• 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.

  PMID: 32336486 BACKGROUND

• 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.

  PMID: 30377439 BACKGROUND

• 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.

  PMID: 31485900 BACKGROUND

• 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.

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• 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.

  PMID: 28728984 BACKGROUND

• 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.

  PMID: 29603126 BACKGROUND

• 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.

  PMID: 20678892 BACKGROUND

• 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.

  PMID: 9494307 BACKGROUND

• 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.

  PMID: 28912083 BACKGROUND

• 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.

  PMID: 9144067 BACKGROUND

• 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.

  PMID: 36992798 BACKGROUND

• 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.

  PMID: 34872712 BACKGROUND

• 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.

  PMID: 29946347 BACKGROUND

• Long B, Robertson J, Koyfman A. Emergency Medicine Evaluation and Management of Small Bowel Obstruction: Evidence-Based Recommendations. J Emerg Med. 2019 Feb;56(2):166-176. doi: 10.1016/j.jemermed.2018.10.024. Epub 2018 Dec 6.

  PMID: 30527563 BACKGROUND

MeSH Terms

Conditions

Frailty; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Daniel B Wilhelms, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research, Department of Emergency Medicine, Associate Professor

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: February 16, 2024
• Study Start: January 1, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-05

Locations

SE (8)