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

NCT05431530RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Seoul National University Hospital

Enrollment

108

Start Date

2022-06-22

Completion Date

2027-05-31

Study Type

OBSERVATIONAL

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

Interventions

Cytoreductive surgery

Conditions

Ovarian CancerLow Anterior Resection SyndromeQuality of Life

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

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

Locations

Seoul National University Hospital, Seoul, South Korea

Linked Papers

2020-04-15

Low anterior resection syndrome (LARS) in ovarian cancer patients - A multi-centre comparative cohort study

Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting the quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Therefore, the study was designed to assess LARS in advanced epithelial ovarian cancer (EOC) patients, who underwent rectal resection and to compare it with a female rectal cancer cohort. A cross-sectional multi-centre analysis was performed on female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen. None of the patients received pre- or postoperative radiotherapy. LARS was defined by using the validated LARS score and its severity was divided into "no", "minor" and "major LARS". In total, 125 female patients (44.8% (n = 56) EOC vs. 55.2% (n = 69) rectal cancer patients) met the final inclusion criteria and were retrospectively analyzed. Baseline characteristics were comparable between the groups. Median follow-up was 22 (IQR 12-56) months. In total, 30.4% (n = 38) of the patient group reported bowel dysfunction after surgery. Rates of LARS were not significantly different between EOC and rectal cancer patients (major LARS 16.1% (n = 9) vs. 15.9% (n = 11); minor LARS 17.9% (n = 10) vs. 11.6% (n = 8); p = 0.984). The time interval between surgery and final assessment had no impact on the postoperative bowel function (p = 0.820). LARS is a frequent and highly underreported postoperative disorder in EOC patients who require cytoreductive surgery with rectal resection. The functional outcome is comparable to female patients with rectal cancer who underwent low anterior resection without receiving radiotherapy.

Linked Investigators

Eloy Espin Basany

Felix Harpain