Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer

Recruiting

• Conditions: Ovarian Cancer; Quality of Life; Low Anterior Resection Syndrome
• Interventions: Procedure: Cytoreductive surgery

• Registration Number: NCT05431530
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Detailed Description

In advanced ovarian cancer, 24-64% of patients require removal of tumors located in the rectum and sigmoid colon. In order to remove the tumor located in the rectum and sigmoid colon, low anterior resection (LAR) is performed to excise the rectum and sigmoid colon. All patients who underwent low anterior resection are at risk of developing low anterior resection syndrome, which presents symptoms such as frequent bowel movements, frequent defecation, and impaired stool control. Therefore, this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Study Timeline

• Study First Submitted: 2022-06-19
• Study First Submitted QC: 2022-06-19
• Study Start: 2022-06-22
• Study First Posted: 2022-06-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

• Those with newly diagnosed ovarian cancer, fallopian tube cancer and primary peritoneal carcinomatosis who plan to undergo cytoreductive surgery and secondary cytoreductive surgery after neoadjuvant chemotherapy.
• Patients with PCDS or rectal and sigmoid coloni tumor invasion suspected on the preoperative image and need resection of the tumor and clinical FIGO stage IIIB or higher
• ECOG performance status : 0-2
• Age over 18

Exclusion Criteria

• Patient who underwent low anterior resection in the past
• Past history of gastrointestinal malignant tumor except to ovarian cancer
• Patient who have colostomy
• Patient who underwent radiation therapy to abdominal or pelvic cavity
• ECOG performance status over 3
• Patient taking opioid analgesics
• Patient who have intellectual disability or dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian cancer	Cytoreductive surgery	Tumor involving rectosigmoid colon

Primary Outcome Measures

Name	Time	Method
Frequency of major LARS after surgery	12 months after LAR implementation	Frequency of major LARS (corresponding to 30-42 points as a result of LARS questionnaire) 12 months after LAR implementation

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-Ov28	2weeks before surgery, 6,12,24 months after surgery	EORTC QLQ-Ov28 of before and after surgery
Bristol stool form scale	2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery	Bristol stool form scale of before and after surgery
Incidence of major, minor LARS after visceral peritoneal stripping	2weeks after surgery	Incidence of major, minor LARS after visceral peritoneal stripping, not LAR
LARS severity	2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery	LARS severity of before and after surgery(before adjuvant chemotherapy)
The fecal incontinency quality of life scale(FIQL)	2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery	FIQL of before and after surgery
EOTC QLQ-C30	2weeks before surgery, 6,12,24 months after surgery	EOTC QLQ-C30 of before and after surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of