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NCT Number: NCT05431530

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

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cytoreductive surgery

Procedure

Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Primary outcomes

  1. Frequency of major LARS after surgery

    Time frame: 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 outcomes

  1. Incidence of major, minor LARS after visceral peritoneal stripping

    Time frame: 2weeks after surgery

    Incidence of major, minor LARS after visceral peritoneal stripping, not LAR

  2. LARS severity

    Time frame: 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)

  3. The fecal incontinency quality of life scale(FIQL)

    Time frame: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery

    FIQL of before and after surgery

  4. Bristol stool form scale

    Time frame: 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

  5. EORTC QLQ-Ov28

    Time frame: 2weeks before surgery, 6,12,24 months after surgery

    EORTC QLQ-Ov28 of before and after surgery

  6. EOTC QLQ-C30

    Time frame: 2weeks before surgery, 6,12,24 months after surgery

    EOTC QLQ-C30 of before and after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Soo Jin Park, MD

CONTACT

[email protected]

+82-02-2072-2388

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: LAPSODY

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2022
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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