Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer
A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University
300 participants
Jan 10, 2024
INTERVENTIONAL
Conditions
Summary
Colorectum is the most common site of metastasis in ovarian cancer. Regarding intestinal surgery, there is controversy over whether to choose bowel resection or tumor removal, and currently, there are no prospective randomized controlled studies comparing the oncological safety of these two surgical approaches. This study is a prospective randomized trial aimed at comparing the efficacy of rectosigmoid resection versus rectosigmoid-preserving lesion excision in advanced ovarian cancer surgery.
Eligibility
Inclusion Criteria7
- Voluntarily participate in this study and sign the informed consent form;
- Age 18-70 years old;
- Primary debulking surgery for epithelial ovarian cancer (including neoadjuvant chemotherapy), with or without abdominal and distant metastasis (≥ IIB stage);
- Colonoscopy negative (no mucosal layer invasion);
- Preoperative imaging (enhanced pelvic MRI) assesses the tumor's involvement of the intestinal surface and/or major parts of the mesentery;
- Eastern Cooperative Oncology Group (ECOG) score < 3;
- American Society of Anesthesiologists (ASA) score < 3.
Exclusion Criteria6
- Has a history of other malignant tumors or is undergoing other anti-tumor treatments;
- Has severe underlying medical conditions that make surgery intolerable;
- Epithelial ovarian cancer diagnosed incidentally during emergency surgery;
- Participates in other clinical studies simultaneously;
- Secondary cytoreductive surgery for epithelial ovarian cancer;
- Patients who have received radiotherapy to the abdomen or pelvis before.
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Interventions
Surgery for pelvic rectosigmoid tumors
Rectosigmoid Resection +tumor cell debulking surgery
Locations(1)
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NCT07616310