Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel Obstruction

Обзор

Rationale: Adhesive small bowel obstruction (aSBO) is a frequent surgical emergency, associated with 3-8% hospital mortality and a high risk of recurrence (20% at two years of follow-up). ASBO can be treated conservatively or by emergency surgery. In the absence of bowel ischemia or strangulation, conservative treatment is often preferred, to avoid the excess morbidity and mortality from emergency surgery. Recent epidemiological studies, however, demonstrate a considerable higher recurrence risk of aSBO after conservative treatment that is associated with hospital readmissions and lower survival. Elective adhesiolysis following successful conservative treatment might reduce these long-term risks whilst avoiding the high complication rate of emergency surgery. Objective: The investigators aim to assess the efficacy of elective adhesiolysis following conservative treatment for aSBO as compared to the current state of the art (wait-and-see policy) to prevent long-term recurrence of aSBO. Further the investigators will evaluate quality of life, healthcare and societal costs. Study design: Multicenter open-label randomized controlled trial, including 380 patients. Study population: Adult patients who recovered from aSBO by conservative treatment. Patients that are inoperable for medical, anaesthesiological or surgical reasons are excluded. Intervention (if applicable): The intervention of investigation is elective adhesiolysis. Adhesiolysis is an abdominal procedure in which all adhesions are cut, and adhesion prevention applied to reduce the risk of adhesion reformation. The intervention is compared to wait-and-see policy (the current standard treatment) Main study parameters/endpoints: Primary outcome is recurrence, defined as readmission for obstructive systems with aetiology of adhesions confirmed by CT. The investigators hypothesize a 50% reduction in recurrence in the intervention arm. Secondary outcomes are morbidity from surgery, health-related quality of life (EQ5D), healthcare costs and societal costs (iMCQ and iPCQ) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the intervention group are exposed to abdominal surgery, which is associated with a moderate risk of minor complications such as wound infection and haemorrhage, and a small risk of severe complications such as iatrogenic bowel injury. According to our hypothesis, a potential benefit is the reduction in the risk of recurrences. Recurrence of aSBO is associated with a risk of readmissions, reinterventions, and also increased long-term mortality.

Вмешательства

• Процедура Elective Adhesionlysis
  See descriptions in study arms
• Устройство Adhesion barrier
  At the end of adhesiolysis a barrier will be placed. The adhesion barrier to be used in laparoscopic adhesiolysis is Icodextrin 4% (Adepttm).

Первичные конечные точки

• recurrence of ASBO at 2-years of follow-up [Срок оценки: 2 years]

Вторичные конечные точки (8)

• Recurrence at 5 year [Срок оценки: 5 years]
• Recurrences needing surgery [Срок оценки: 2 years and 5 years]
• Morbidity from elective adhesiolysis [Срок оценки: 90 days]
• Health related quality of life [Срок оценки: 2 years]
• Gastro-intestinal related quality of life [Срок оценки: 2 years]
• Healthcare costs [Срок оценки: 2 years]
• Societal costs [Срок оценки: 2 years]
• Cost-effectiveness [Срок оценки: 2 years and 5 years]

Критерии участия

Критерии включения

• Adult patients aged 18 years and older who have recently recovered from aSBO by small bowel obstruction managed by conservative treatment.
• Patients who have previously been operated (high a prior risk of adhesions) are required to have no signs of other causes of bowel obstruction on imaging studies (CT-scan).
• Patients with no previous operation in history (low a prior risk of adhesions) are required to have typical signs for aSBO on imaging studies (abrupt change of bowel calibre, closed loop, or signs of torsion on vessels in the mesentery on CT-scan).

Критерии исключения

• Patient who are unfit for reoperation for surgical, anesthesiological or medical reasons as determined by multidisciplinary team assessment or pre-operative screening
• Patients with active malignancy, reducing life expectancy
• Pregnancy

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

Нидерланды · 9 центров

• ZGT Almelo — Almelo
• OLVG Amsterdam — Amsterdam
• Maasziekenhuis Pantein Boxmeer — Boxmeer
• St. Jansdal Harderwijk — Harderwijk
• MaastrichtUMC+ — Maastricht
• RadboudUMC — Nijmegen
• Laurentius Ziekenhuis Roermond — Roermond
• St. Franciscus gasthuis Rotterdam — Rotterdam
• … и ещё 1 центр

Бельгия · 5 центров

• UZ Antwerpen — Antwerp
• Hôpital Erasme — Brussels
• UZ Brussel — Brussles
• UZ Leuven (National Coordinating Center) — Leuven
• Vitaz Sint-Niklaas — Sint-Niklaas

Публикации

• Krielen P, Kranenburg LPA, Stommel MWJ, Bouvy ND, Tanis PJ, Willemsen JJ, Migchelbrink J, de Ree R, Bormans EMG, van Goor H, Ten Broek RPG; ASBO Snapshot Study Group. Variation in the management of adhesive small bowel obstruction in the Netherlands: a prospective cross-sectional study. Int J Surg. 2023 Aug 1;109(8):2185-2195. doi: 10.1097/JS9.0000000000000471. PMID 37288588
• van den Beukel BAW, Toneman MK, van Veelen F, van Oud-Alblas MB, van Dongen K, Stommel MWJ, van Goor H, Ten Broek RPG. Elective adhesiolysis for chronic abdominal pain reduces long-term risk of adhesive small bowel obstruction. World J Emerg Surg. 2023 Jan 23;18(1):8. doi: 10.1186/s13017-023-00477-9. PMID 36691000

Идентификаторы

NCT: NCT06777446 · NL88020.091.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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