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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Rectosigmoid Lesion Excision +tumor cell debulking surgery
  • Rectosigmoid Resection +tumor cell debulking surgery

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Tongji Hospital

Collaborator

Zhejiang University

Collaborator

Zhejiang Provincial People's Hospital

Collaborator

Zhejiang Cancer Hospital

Collaborator

Huzhou Central Hospital

Collaborator

Ningbo Women & Children's Hospital

Collaborator

Shaoxing People's Hospital

Collaborator

The Central Hospital of Lishui City

Collaborator

Women's Hospital School Of Medicine Zhejiang University

Collaborator