Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy
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: Double drains will be placed, A single drain will be placed.
- Кому может быть актуально
- Состояния в реестре: Seroma Following Procedure, Infections, Pain, Postoperative. Базовые параметры: 18 лет — 70 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
- Пакистан
- 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
Comparative Analysis of Quilting Sutures With a Single Axillary Drain Versus Double Drains in the Axillary and Pectoral Regions for the Prevention of Seroma After Modified Radical Mastectomy
Обзор
Normally, after this surgery, skin is stitched in the usual simple way, with no quilting, and two drains are put in to remove serosa, one under the arm and one on the chest. In this study, the investigator will use a different type of stitch called a quilting stitch, which helps stick the skin to the chest muscle so there is less serosa collection. The investigator will compare two groups: * Group A: Quilting stitches with two drains (one under the arm and one on the chest). * Group B: Quilting stitches with one drain only (under the arm).
Подробное описание
All surgeries in this study will be performed by a consultant surgeon with at least 2 years of experience in breast surgery. This ensures uniformity and minimizes variation in outcomes related to surgical expertise Patients undergoing MRM will be divided into two groups, A \& B. Flap quilting (skin flaps are sutured to the pectoralis muscle in interrupted fashion) will be done in both the groups using a Vicryl 2/0 suture, \& skin will be closed using skin staplers.
Participants will be randomly assigned to one of the two study groups (Group A or Group B) using computer-based randomisation software. This ensures that the allocation is unbiased and purely by chance.
In group A double drains will be placed, one in pectoral region and the other in axillary region, while in group B single drain will be placed in axillary region; a 20 Fr JP drain would be used in both the groups Participants will be informed about the study's purpose, confidentiality will be ensured, and written informed consent will be obtained in the language of their preference (English/Urdu).
Observation will be made on the seroma formation, drain outputs, duration of drain placement \& pain using the Visual Analogue Score (VAS) \& incidence of surgical site infection.
The patient would be followed for drain output from postoperative day 1 to 30 (depending upon the removal of the drain), POD 7 \& POD 14 and the subsequent next follow-up, \& the patients will be assessed for seroma formation \& surgical site infection \& pain score. Seroma formation will be detected on clinical evaluation \& will be confirmed on ultrasound imaging.
Patients who have received neoadjuvant therapy may have a higher risk of skin- and soft-tissue-related complications such as delayed wound healing, infection, or seroma formation. This factor will be considered in the analysis
Вмешательства
- Процедура Double drains will be placed
In group A double drains will be placed, one in pectoral region and the other in axillary region. - Процедура A single drain will be placed
A single drain will be placed in axillary region.
Первичные конечные точки
- Seroma Formation [Срок оценки: Post-operative day 1 to day 30]
Вторичные конечные точки (3)
- Infection [Срок оценки: Post-operative day 1 to day 30]
- Duration of drains [Срок оценки: Post-operative day 1 to day 30]
- Post-operative pain [Срок оценки: Post-operative day 1 to day 30]
Критерии участия
Критерии включения
- All patients older than 18 years but less than 70 years of age,
- Diagnosed with breast carcinoma.
- All the patients undergoing upfront MRM,
- All patients undergoing MRM post-neoadjuvant chemotherapy.
Критерии исключения
- Mastectomy \& sentinel lymph node biopsy
- Breast reconstruction surgery
- Defect covering flaps
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
- Профилактика
Центры проведения
Пакистан · 1 центр
- Sindh Institute of Urology and Transplantation — Karachi
Идентификаторы
NCT: NCT07512141 · SIUT-ERC-2025/A-577