Clinical trial NCT05431530: Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Low Anterior Resection Syndrome
Quality of Life
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of major LARS after surgery
timeFrame: 12 months after LAR implementation
Secondary outcomes:
measure: Incidence of major, minor LARS after visceral peritoneal stripping
timeFrame: 2weeks after surgery
measure: LARS severity
timeFrame: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
measure: The fecal incontinency quality of life scale(FIQL)
timeFrame: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
measure: Bristol stool form scale
timeFrame: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
measure: EORTC QLQ-Ov28
timeFrame: 2weeks before surgery, 6,12,24 months after surgery
measure: EOTC QLQ-C30
timeFrame: 2weeks before surgery, 6,12,24 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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