The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction
NCT ID: NCT06262815
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-01-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with nasogastric tube treatment
Adult patients with diagnosed small bowel obstruction in the Emergency Department for a nasogastric tube was placed
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
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.
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.
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.
Interventions
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Nasogastric tube placement
Conventional nasogastric tube placement done for decompression of small bowel obstruction
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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 or older
Exclusion Criteria
* Not able to give informed consent
ALL
Yes
Sponsors
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Linkoeping University
OTHER_GOV
Daniel Wilhelms
OTHER
Responsible Party
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Daniel Wilhelms
Head of Research, Department of Emergency Medicine, Associate Professor
Principal Investigators
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Daniel B Wilhelms, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Östra sjukhuset
Gothenburg, , Sweden
Skånes Universitetssjukhus
Lund, , Sweden
Skånes Universitetssjukhus
Malmo, , Sweden
Lasarett i Motala
Motala, , Sweden
Vrinnevisjukhuset
Norrköping, , Sweden
Sundsvalls sjukhus
Sundsvall, , Sweden
Akutmottagningen US Östergötland
Linköping, Östergötland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Nina Bardhi, MD
Role: primary
Mathias Jerkfelt, MD
Role: primary
Sigrid Wallden, MD
Role: primary
Robert Schytzer, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2023-06806-01
Identifier Type: -
Identifier Source: org_study_id
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