Optimizing Treatment of Adhesive Small Bowel Obstruction

Официальное название

The Use of Nasogastric Tubes And Water-Soluble Contrast In The Management Of Small Bowel Obstruction: A Feasibility Study

Обзор

Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO. This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.

Вмешательства

• Препарат Gastrografin
  Administration of WSC (Gastrografin) 2 hours after placement of NGT.
• Препарат Saline
  Administration of Saline 2 hours after placement of NGT.
• Процедура SBO Treatment Without NG Tubes
  Patients who decline to have NG tubes placed will be enrolled and followed with the same outcomes protocol as the other patients in the trial

Первичные конечные точки

• Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 [Срок оценки: The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge.]

Критерии участия

Критерии включения

• Male or female ≥18 years of age.
• Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria: Nausea, emesis, abdominal pain, distended abdomen CT evidence of aSBO

Критерии исключения

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
• Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
• Nonadhesive SBO

• Paralytic Ileus
• Incarcerated hernia
• Fecal impaction
• Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, Los Angeles, David Geffen School of Medicine — Los Angeles

Идентификаторы

NCT: NCT06182319 · 23-001055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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