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Набор скоро начнётся NCT07078981

Adhesion Prevention in ASBO Surgery Using 4DryField® PH

— Наблюдательное Adhesive Small Bowel Obstruction Postoperative Abdominal Adhesions Bowel Obstruction Abdominal Surgery Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Adhesive Small Bowel Obstruction, Postoperative Abdominal Adhesions, Bowel Obstruction, Abdominal Surgery Complications. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessing Determinants of Headway in Evaluating Risk of Adhesion: the ADHERE Study

Обзор

Post-surgical adhesions occur in up to 90% of abdominal surgeries, often leading to complications like adhesive small bowel obstruction (ASBO) and chronic pain. They result from imbalanced healing processes influenced by growth factors, fibroblast activity, and genetic predispositions. While surgery can relieve ASBO, it frequently causes new adhesions, with recurrence rates up to 40%. Anti-adhesion barriers, such as the starch-based 4DryField® PH, form a temporary gel barrier to support healing. Though promising, its role in preventing ASBO recurrence is not well studied. This study evaluates whether intra-operative use of 4DryField® PH reduces ASBO recurrence over 12 months and compares perioperative outcomes in treated vs. untreated patients.

Подробное описание

Post-surgical adhesions are a common complication of abdominal surgery, with an occurrence rate of approximately 79-90%, leading to significant morbidity such as adhesive small bowel obstruction (ASBO) and chronic pain (1,2). These adhesions result from increased extracellular matrix production, reduced fibrinolytic activity, and the influence of growth factors like TGF-beta and VEGF, along with fibroblast proliferation(1). Genetic predispositions-affecting pathways such as TGF-β, VEGF, PAI-1, MMPs, and various pro-inflammatory cytokines-may increase the risk of adhesion formation(2-5).

Surgical management of ASBO resolves acute symptoms but often exacerbates the underlying issue by inducing further peritoneal trauma. Recurrence rates remain high-reported in up to 40% of patients-and complications from repeated adhesiolysis include increased operative time, bowel injury, and postoperative morbidity(6).

Various strategies have been explored in different surgical fields to prevent adhesion formation, including the use of physical antiadhesion barriers(7-9). Among these, 4DryField® PH, a plant-derived starch powder, has been shown to be safe and effective in clinical and experimental studies(8,10). When hydrated with saline, the powder forms a biocompatible gel that acts as a temporary barrier to physically separate traumatized serosal surfaces and allow for proper mesothelial regeneration.

Although the use of 4DryField® PH has been studied in different settings, there is limited prospective evidence evaluating its role in preventing recurrence of ASBO.

The present study aims to fill this gap by assessing whether intraoperative application of 4DryField® PH during surgery for ASBO reduces the recurrence rate during a 12-month follow-up, and by comparing perioperative outcomes between treated and untreated patients.

Первичные конечные точки

  • Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months [Срок оценки: 12 months post-surgery]
Вторичные конечные точки (1)
  • Postoperative complications within 90 days [Срок оценки: 90 days post-surgery]

Критерии участия

Критерии включения

Age ≥ 18 years

  • Undergoing surgical treatment for adhesive small bowel obstruction (ASBO)
  • Ability and willingness to provide informed consent
  • Willingness to adhere to follow-up visits

Критерии исключения

  • Presence of peritonitis
  • Intra-abdominal active malignancy
  • Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Ahmad M, Crescenti F. Significant Adhesion Reduction with 4DryField PH after Release of Adhesive Small Bowel Obstruction. Surg J (N Y). 2019 May 10;5(1):e28-e34. doi: 10.1055/s-0039-1687857. eCollection 2019 Jan. PMID 31093531
  • Lorentzen L, Oines MN, Oma E, Jensen KK, Jorgensen LN. Recurrence After Operative Treatment of Adhesive Small-Bowel Obstruction. J Gastrointest Surg. 2018 Feb;22(2):329-334. doi: 10.1007/s11605-017-3604-x. Epub 2017 Oct 13. PMID 29030779
  • Awonuga AO, Fletcher NM, Saed GM, Diamond MP. Postoperative adhesion development following cesarean and open intra-abdominal gynecological operations: a review. Reprod Sci. 2011 Dec;18(12):1166-85. doi: 10.1177/1933719111414206. Epub 2011 Jul 20. PMID 21775773

Идентификаторы

NCT: NCT07078981 · ADHERE2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗