Actively Recruiting

Age: 18Years +
FEMALE
ID05431530

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

Led by Seoul National University Hospital · Updated on 2023-06-27

108

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the occurrence of low anterior resection syndrome (LARS) and the quality of life in patients with advanced ovarian cancer undergoing cytoreductive surgery. This surgery often involves removing tumors from the rectum and sigmoid colon, which can lead to symptoms like frequent bowel movements and loss of stool control. The study focuses on patients with advanced ovarian cancer who require this type of tumor removal to better understand the impact on their health and daily life. The study evaluates cytoreductive surgery that includes removing tumors involving the rectosigmoid colon. Participants are observed to assess the frequency and severity of LARS after surgery and their quality of life. Assessments occur at multiple time points including before surgery, shortly after surgery, and up to 24 months following surgery, capturing changes over time. Participants will be monitored through various evaluations such as symptom questionnaires, quality of life scales, and stool form assessments at regular intervals before and after surgery. The primary measurement is the frequency of major LARS symptoms 12 months after surgery. Secondary assessments include LARS severity, fecal incontinence impact, stool form, and quality of life related to ovarian cancer symptoms. Safety and well-being will be followed throughout the study period, which may last up to 24 months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal carcinomatosis patients planning cytoreductive surgery or secondary cytoreductive surgery after neoadjuvant chemotherapy
  • Suspected tumor invasion of rectum or sigmoid colon on preoperative imaging with clinical FIGO stage IIIB or higher
  • ECOG performance status of 0 to 2
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • History of low anterior resection surgery
  • Previous gastrointestinal malignant tumor except ovarian cancer
  • Presence of colostomy
  • Prior radiation therapy to the abdomen or pelvic area
  • ECOG performance status over 3
  • Current use of opioid pain medications
  • Intellectual disability or dementia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo cytoreductive surgery including resection of tumors involving the rectosigmoid colon and receive immediate post-operative care.

1 surgery visit and approximately 1 post-operative visit within 2 weeks

Post-operative Follow-up

Duration - Up to 24 months after surgery

Participants are monitored for symptoms of low anterior resection syndrome and quality of life through scheduled assessments after surgery.

Visits at 2 weeks, 3 months, 6 months, 12 months, and 24 months after surgery

Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

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Research Team

S

Soo Jin Park, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis.

Robert E Bristow, Rafael S Tomacruz, Deborah K Armstrong...

https://pubmed.ncbi.nlm.nih.gov/11870167

Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial.

Tina Yen-Ting Chen, Lisette M Wiltink, Remi A Nout...

https://pubmed.ncbi.nlm.nih.gov/25677122

Factors determining low anterior resection syndrome after rectal cancer resection: A study in Thai patients.

Patomphon Ekkarat, Teeranut Boonpipattanapong, Kasaya Tantiphlachiva...

https://pubmed.ncbi.nlm.nih.gov/26340884

Does a Defunctioning Stoma Impair Anorectal Function After Low Anterior Resection of the Rectum for Cancer? A 12-Year Follow-up of a Randomized Multicenter Trial.

Soran Gadan, Hannah Floodeen, Rickard Lindgren...

https://pubmed.ncbi.nlm.nih.gov/28682965

An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer.

E Greimel, A Bottomley, A Cull...

https://pubmed.ncbi.nlm.nih.gov/12826043