About this trial
This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
According to the existing literature report, 37.9% to 43.3% of cases of low anterior resection are expected to occur. Therefore, assuming that the major LARS incidence rate is 40%, and the number of subjects to estimate the incidence rate estimation precision (half of the 95% confidence interval width) within 10% is 93 patients. Considering the loss or death rate of 13.2% during follow-up within 1 year in our hospital, the number of subjects required is 108.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cytoreductive surgery
Procedure/SurgeryCytoreductive surgery including resection of tumors involving rectosigmoid colon.
Treatment groups
Trial 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
Secondary outcomes
Incidence of major, minor LARS after visceral peritoneal stripping
Incidence of major, minor LARS after visceral peritoneal stripping, not LAR
LARS severity
LARS severity of before and after surgery(before adjuvant chemotherapy)
The fecal incontinency quality of life scale(FIQL)
FIQL of before and after surgery
Bristol stool form scale
Bristol stool form scale of before and after surgery
Sponsors and contacts
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