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Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer

RECRUITINGN/ASponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University
Actively Recruiting
PhaseN/A
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Started2024-01-10
Est. completion2028-12-31
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years – 70 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

CancerOvarian Cancer (OvCa)

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