Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery
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: Rectosigmoid resection.
- Кому может быть актуально
- Состояния в реестре: Epithelial Ovarian Cancer, Rectosigmoid Cancer Metastatic. 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
- Turkey (Türkiye)
- 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
Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)
Обзор
Ovarian cancer is the most common cause of death in gynecological cancer. Approximately 75% of epithelial ovarian cancers are detected at an advanced stage. Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. Metastasis mostly occurs in the peritoneum, omentum, and intestines. The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood. Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. Surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: R0). The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. Multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction. In the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. There are advantages and disadvantages of each method in terms of morbidity. Although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.
Вмешательства
- Процедура Rectosigmoid resection
Most of the colorectal involvements are observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed.
Первичные конечные точки
- Local pelvic recurrence [Срок оценки: 0-60 months.]
- Recurrence-free survival [Срок оценки: 0-60 months.]
Вторичные конечные точки (4)
- Cancer specific survival [Срок оценки: 0-100 months]
- Surgery related morbidities [Срок оценки: 90 days.]
- Health related Quality of life [Срок оценки: 0-24 months.]
- Overall survival [Срок оценки: 0-100 months.]
Критерии участия
Критерии включения
- Epithelial ovarian cancer
- Negative colonoscopy ( no mucosal involvement)
- Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration
- ECOG <3
- ASA <3
Критерии исключения
- Nonepithelial ovarian cancers
- Rectosigmoid mucosal infiltration
- Total or subtotal colectomy necessitating large bowel infiltrations
- ECOG >2
- ASA >2
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
Turkey (Türkiye) · 2 центра
- Cukurova University — Adana
- Cukurova University — Adana
Публикации
- Erkilinc S, Karatasli V, Demir B, Cakir I, Can B, Karadeniz T, Gokcu M, Sanci M. Rectosigmoidectomy and Douglas Peritonectomy in the Management of Serosal Implants in Advanced-Stage Ovarian Cancer Surgery: Survival and Surgical Outcomes. Int J Gynecol Cancer. 2018 Nov;28(9):1699-1705. doi: 10.1097/IGC.0000000000001368. PMID 30371561
- Gallotta V, Fanfani F, Vizzielli G, Panico G, Rossitto C, Gagliardi ML, Margariti PA, Salerno MG, Zannoni GF, Pacelli F, Scambia G, Fagotti A. Douglas peritonectomy compared to recto-sigmoid resection in optimally cytoreduced advanced ovarian cancer patients: analysis of morbidity and oncological outcome. Eur J Surg Oncol. 2011 Dec;37(12):1085-92. doi: 10.1016/j.ejso.2011.09.003. Epub 2011 Sep 25. PMID 21945640
- Aletti GD, Podratz KC, Jones MB, Cliby WA. Role of rectosigmoidectomy and stripping of pelvic peritoneum in outcomes of patients with advanced ovarian cancer. J Am Coll Surg. 2006 Oct;203(4):521-6. doi: 10.1016/j.jamcollsurg.2006.06.027. Epub 2006 Aug 23. PMID 17000396
Идентификаторы
NCT: NCT04665635 · 105/17- Ov01