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.
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);
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;
Parallel
Rectosigmoid Lesion Excision +tumor cell debulking surgery
Procedure/SurgerySurgery for pelvic rectosigmoid tumors
Rectosigmoid Resection +tumor cell debulking surgery
Procedure/SurgeryRectosigmoid Resection +tumor cell debulking surgery
Progression-free survival(PFS)
Two years progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
Local recurrence rate in the pelvic region(LPR)
The proportion of cases with local recurrence in the pelvic area among the total number of enrolled cases
Overall Survival(OS)
OS is defined as the time from the date of randomization until death
Surgical Complications(SC)
It refers to all the cases where the subjects experienced surgery-related complications, including the type, incidence rate, and severity (graded according to CTCAE V5.0)
Ratio of R0
The proportion of cases that underwent R0 resection (complete resection) among the total number of enrolled cases.
Click on the lead sponsor to view all of their trials.
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
