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A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Jing Fei
feijing@zju.edu.cn
+86 13732238958
Backup
Zhigang Zhang
zzg2011@zju.edu.cn
+86 15088621550
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Rectosigmoid Lesion Excision
rectosigmoid lesion excision +tumor cell debulking surgery
Active_comparator: Rectosigmoid Resection
rectosigmoid resection +tumor cell debulking surgery
Related Therapeutic Areas
Sponsors
Collaborators: Women's Hospital School Of Medicine Zhejiang University, Huzhou Central Hospital, Zhejiang University, Shaoxing People's Hospital, Zhejiang Cancer Hospital, Ningbo Women & Children's Hospital, Tongji Hospital, The Central Hospital of Lishui City, Zhejiang Provincial People's Hospital
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov