Low Anterior Resection Syndrome, Ovarian Cancer, Quality of Life
Conditions
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.
Interventions
PROCEDURECytoreductive surgery
Cytoreductive surgery including resection of tumors involving rectosigmoid colon.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of major, minor LARS after visceral peritoneal stripping | 2weeks after surgery | Incidence of major, minor LARS after visceral peritoneal stripping, not LAR |
| EORTC QLQ-Ov28 | 2weeks before surgery, 6,12,24 months after surgery | EORTC QLQ-Ov28 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactSoo Jin Park, MD
Outcome results
None listed