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

June 25, 2023 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ovarian cancer
Tumor involving rectosigmoid colon
Procedure: Cytoreductive surgery
Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after LAR implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2weeks after surgery
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)
2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
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
2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
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
2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
EORTC QLQ-Ov28
Time Frame: 2weeks before surgery, 6,12,24 months after surgery
EORTC QLQ-Ov28 of before and after surgery
2weeks before surgery, 6,12,24 months after surgery
EOTC QLQ-C30
Time Frame: 2weeks before surgery, 6,12,24 months after surgery
EOTC QLQ-C30 of before and after surgery
2weeks before surgery, 6,12,24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee Seung Kim, MD/PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

June 19, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LARS-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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