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Идёт набор NCT07213193

No-Stoma Policy in Advanced Ovarian Cancer Surgery

Без фазы С лечением Ovary Cancer

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
В протоколе указаны: colon-rectal resection.
Кому может быть актуально
Состояния в реестре: Ovary Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
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

No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes

Обзор

Resection of the sigmoid-rectum is a procedure frequently required in cytoreductive surgery for advanced ovarian cancer, and it is also among the procedures with the highest risk of complications. One of the major, albeit uncommon, complications of intestinal anastomosis is anastomotic leakage. According to the literature, the rate of anastomotic leakage following cytoreductive surgery for ovarian cancer ranges from 1.7% to 17%. The risk factors associated with this complication are varied and often inconsistent across studies. They range from preoperative clinical conditions-such as age, low albumin levels, and Body Mass Index \< 18-to intraoperative factors such as low to mid rectal resection, high ligation of the inferior mesenteric artery, and multiple bowel resections. Apart from the rehabilitative programs introduced by the Enhanced Recovery After Surgery protocol-which aim to improve the nutritional status of patients undergoing cytoreductive surgery for ovarian cancer-we currently lack validated tools to reduce the risk of leakage. The most commonly used strategy remains the creation of a protective stoma. However, several studies have shown that this procedure is not actually a protective factor against anastomotic leakage; rather, its utility lies in mitigating the severity of the complication. Nonetheless, stomas have a significant clinical and psychological impact, with complication rates ranging from 33.9% to 45% and reversal rates between 66.5% and 89%. This study aims to evaluate the feasibility of a no-stoma strategy in a selected "low-risk" population for anastomotic leakage among patients undergoing cytoreductive surgery for primary or recurrent ovarian cancer. Focusing on the goal of achieving a zero stoma rate, the study will provide valuable insights into the utility and outcomes of stoma creation. The results will support more informed and patient-centered clinical decisions in the management of ovarian cancer.

Вмешательства

  • Процедура colon-rectal resection
    The patients who underwent colon rectal resection, would be evaluated for stomia or not.

Первичные конечные точки

  • Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors [Срок оценки: Intraoperative and postoperative follow-up period (90 days postoperative)]
Вторичные конечные точки (4)
  • Risk Factors for Anastomotic Leak [Срок оценки: preoperative, intraoperative]
  • Rate of Occult Anastomotic Leak in Patients With Diverting Ostomy [Срок оценки: Postoperative days up to 20.]
  • Management Strategies for Anastomotic Leak [Срок оценки: Postoperative period (up to 90 days).]
  • Impact of Bowel Surgery on Quality of Life [Срок оценки: Baseline (pre-surgery), 3 months, and 6 months post-surgery.]

Критерии участия

Критерии включения

  • Patients with suspected or anatomopathological diagnosis of malignant ovarian tumor undergoing elective primary or secondary cytoreduction and needing rectosigmoid resection and anastomosis
  • Informed consent signed prior to performing any procedure related to the clinical trial
  • Age 18 years old.

Критерии исключения

  • Patients with histologies other than ovarian tumor.
  • Only palliative surgery planned
  • Patients who do not require sigmoid-rectum resection after intraoperative evaluation
  • Patients who do not receive colorectal anastomosis and undergo end ostomy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Италия · 1 центр
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica — Roma

Идентификаторы

NCT: NCT07213193 · 7620

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗