Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
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: Reconstruction with robot-assisted rectus abdominis muscle flap.
- Кому может быть актуально
- Состояния в реестре: Perineum; Wound, Postoperative Complications, Rectal Neoplasms, Rectus Abdominis Hernia. 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
- Норвегия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. Operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.
Подробное описание
Inclusion criteria:
Patients \> 18 years of age operated with robotic-assisted abdominoperineal resection for irradiated locally advanced rectal or anal cancer where robotic-assisted perineal and/or vaginal reconstruction has been performed with a rectus abdominis muscle flap.
Methods Up to 40 patients operated with robotic-assisted abdominoperineal resection with Da Vinci Xi surgical system (Intuitive Surgical, Sunnyvale, California, USA) and robotic-assisted reconstruction with a pedicled rectus muscle will be included in this prospective, non-randomized study.
In addition to the standardized post-operative care for patients with locally advanced rectal or anal cancer as specified by national guidelines, patients will be offered study-specific follow-up visits at 1, 6 and 12 months.
Complications are recorded by the accordion severity grading system of surgical complications. Patient related outcomes measures will be registered by using European organization for research and treatment of cancer Quality of life questionnaire Core 30 (EORTC QLQ-C30). Sexual health will be registered by a subset of questions from European organization for research and treatment of cancer Quality of life questionnaire Sexual health (EORTC QLQ-SH22).
Primary endpoint:
\- perineal wound healing at 3 months
Secondary endpoints:
* early (\< 30 days) and late (\> 30 days) complications * quality of life preoperatively and at 3- and 12 months postoperatively * sexual function preoperatively and at 3- and 12 months postoperatively * clinical evaluation of abdominal wall strength preoperatively, at 3- and 12 months postoperatively
Вмешательства
- Процедура Reconstruction with robot-assisted rectus abdominis muscle flap
Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.
Первичные конечные точки
- Perineal wound healing [Срок оценки: 3 months]
Вторичные конечные точки (5)
- Early postoperative complications [Срок оценки: Within 30 days postoperatively]
- Late postoperative complications [Срок оценки: Later than 30 days postoperatively]
- Quality of life - general [Срок оценки: Preoperatively. 3 months and 12 months postoperatively.]
- Quality of life - sexual [Срок оценки: Preoperatively. 3 months and 12 months postoperatively.]
- Abdominal wall strength [Срок оценки: Preoperatively. 3 months and 12 months postoperatively.]
Критерии участия
Критерии включения
- patients with rectal or anal cancer
- scheduled for robot-assisted abdominoperineal resection
- reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
Критерии исключения
- patients not eligible for robot-assisted procedure
- rectus abdominis muscle not available for harvest
- the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Норвегия · 1 центр
- Oslo University Hospital, Radiumhospitalet — Oslo
Идентификаторы
NCT: NCT05689775 · 387180