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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Quality of Life After Low Anterior Resection or Visceral Peritoneal Stripping During cytOreDuctive surgerY for Advanced Ovarian Cancer Requiring Tumor Resection on the Rectosigmoid Colon: a Prospective Cohort Study

Conditions
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Ovarian Cancer, Low Anterior Resection Syndrome, Quality of Life

Intervention / Treatment
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* Procedure: Cytoreductive surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian cancer<br>Tumor involving rectosigmoid colon | Procedure: Cytoreductive surgery<br>* Cytoreductive surgery including resection of tumors involving rectosigmoid colon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of major LARS after surgery | Frequency of major LARS (corresponding to 30-42 points as a result of LARS questionnaire) 12 months after LAR implementation | 12 months after LAR implementation | 

Secondary Outcome Measures

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