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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSeoul National University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cytoreductive surgery

    Procedure/Surgery

    Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: Ovarian cancer1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

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