protocolSection identificationModule nctId: NCT06262815, orgStudyIdInfo id: 2023-06806-01, briefTitle: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction, acronym: NGTUBE-OBS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Daniel Wilhelms, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: 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., conditionsModule conditions: Small Bowel Obstruction, conditions: Frailty, conditions: Nasogastric Tube, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Nasogastric tube placement, interventions name: Clinical Frailty Scale, outcomesModule primaryOutcomes measure: Pain at Emergency Department discharge, secondaryOutcomes measure: Nausea at Emergency Department discharge, secondaryOutcomes measure: Hospital Length of Stay, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Admission for Small bowel obstruction, secondaryOutcomes measure: Emergency Surgery, secondaryOutcomes measure: Emergency Department Length of Stay, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sahlgrenska Universitetssjukhuset, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Nina Bardhi, MD, role: CONTACT, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Östra sjukhuset, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Mathias Jerkfelt, MD, role: CONTACT, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Skånes Universitetssjukhus, status: ACTIVE_NOT_RECRUITING, city: Lund, country: Sweden, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Skånes Universitetssjukhus, status: ACTIVE_NOT_RECRUITING, city: Malmö, country: Sweden, geoPoint lat: 55.60587, lon: 13.00073, locations facility: Lasarett i Motala, status: RECRUITING, city: Motala, country: Sweden, contacts name: Jens Wretborn, PhD, role: CONTACT, phone: +46101033000, email: jens.wretborn@regionostergotland.se, geoPoint lat: 58.53706, lon: 15.03649, locations facility: Vrinnevisjukhuset, status: RECRUITING, city: Norrköping, country: Sweden, contacts name: Sigrid Wallden, MD, role: CONTACT, geoPoint lat: 58.59419, lon: 16.1826, locations facility: Sundsvalls sjukhus, status: RECRUITING, city: Sundsvall, country: Sweden, contacts name: Robert Schytzer, MD, role: CONTACT, geoPoint lat: 62.39129, lon: 17.3063, locations facility: Akutmottagningen US Östergötland, status: RECRUITING, city: Linköping, state: Östergötland, zip: 58185, country: Sweden, contacts name: Jens Wretborn, PhD, role: CONTACT, phone: +46101033000, email: jens.wretborn@regionostergotland.se, contacts name: Alaa Hussein, MD, role: CONTACT, phone: +46101033000, email: alaa.hussein@regionostergotland.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False