Suprapubic Transverse Incision With Rectus Release for Upper Peritoneal Access): A Novel Dual-Plane Technique for Abdominal Wall Incision in Complex Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Postoperative seroma formation
研究概览
简要总结
This study aims to evaluate the clinical effectiveness, anatomical benefits, and postoperative outcomes of the STIRRUP incision (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal Access) by comparing outcomes with historically established benchmarks and published data from traditional abdominal wall incisions used in complex gynecologic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-65 years
- •Indication for open gynecologic surgery for benign or borderline pelvic or abdominopelvic masses
- •Body Mass Index (BMI) ≥ 18 kg/m²
- •Willing and able to provide informed consent and attend follow-up
- •Mass size between 15-30 cm, which is considered optimal for the STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique due to the balance between exposure and minimal morbidity
排除标准
- •Malignant tumors requiring upper abdominal visceral resection (liver, spleen, diaphragm)
- •Emergency surgery
- •Previous complex abdominal wall reconstruction with mesh
- •Contraindication to general anesthesia
- •Masses extending to the xiphisternum or measuring >30 cm
- •Cases requiring supracolic omentectomy
- •Planned lymphadenectomy (especially if comprehensive para-aortic lymph node dissection is required )
- •Supramesocolic tumor extension or malignant ovarian tumors requiring hepatic resections, splenectomy, and diaphragmatic resection
- •Severe comorbidities precluding elective surgery
- •Previous extensive upper abdominal surgery
研究组 & 干预措施
STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique
Skin incision: A low curvilinear transverse incision will be made 2-3 cm above the pubic symphysis, corresponding to the Pfannenstiel site.
Subcutaneous dissection: The subcutaneous tissue will be elevated between Scarpa's fascia and the anterior rectus sheath for approximately 10-12 cm cephalad.
Anterior rectus sheath incision: A transverse incision will be made in the anterior rectus sheath approximately 10-12 cm above the pubis, parallel to the skin incision. The linea alba will not be divided, thereby preserving midline fascial integrity.
Rectus muscle separation: Beneath the fascial window, the rectus muscles will be separated bluntly at the midline, as in the Pfannenstiel approach, to expose the posterior sheath and peritoneum. No transection of muscle fibers will be performed.
Peritoneal entry: The peritoneum will be opened sharply under direct vision.
干预措施: STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique (Procedure)
结局指标
主要结局
Postoperative seroma formation
时间窗: within the postoperative or follow-up period (6 months)
clinically detectable subcutaneous fluid collection at the incision site, confirmed clinically and/or by ultrasound when indicated.
次要结局
未报告次要终点
研究者
Abdalla Mousa
Lecturer of Obstetrics and Gynecology
Cairo University