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

Seoul National University Hospital108 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

108

Conditions

Ovarian Cancer Low Anterior Resection Syndrome Quality of Life

Interventions

Cytoreductive surgeryPROCEDURE

Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 months after LAR implementation

Secondary Outcomes

Incidence of major, minor LARS after visceral peritoneal stripping

Incidence of major, minor LARS after visceral peritoneal stripping, not LAR

Time frame: 2weeks after surgery

LARS severity

LARS severity of before and after surgery(before adjuvant chemotherapy)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 2weeks before surgery, 6,12,24 months after surgery

EOTC QLQ-C30

EOTC QLQ-C30 of before and after surgery

Time frame: 2weeks before surgery, 6,12,24 months after surgery

Central Contacts

Soo Jin Park, MD

CONTACT

+82-02-2072-2388 soojin.mdpark@gmail.com

Data from ClinicalTrials.gov

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