Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer

NCT ID: NCT06527001

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-16

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ovarian cancer is one of the three major malignant tumors in gynecology, causing more than 200,000 deaths globally each year, with the highest mortality rate. However, due to its insidious onset and lack of specificity in clinical manifestations, nearly 70% of patients are in advanced stages upon diagnosis. Ovarian cancer often spreads along the peritoneal surface of the abdominal and pelvic cavity and involves the intestines through direct extension or plasma membrane infiltration, resulting in impaired intestinal function and intestinal obstruction. Cytoreductive Surgery is a critical treatment for patients with ovarian cancer. Literature reports that about 60%-70% of patients with advanced ovarian cancer underwent bowel resection at the time of primary debulking surgery, with the main site of resection being the recto-sigmoid (48%-55%), followed by the rest of the colon (18%-20%) and the small bowel (6%-27%). Patients with bowel resection for ovarian cancer often have involvement of mesenteric lymph nodes (MLN), and the positive rate of MLN fluctuates from 37% - 79.4%, and the incidence of liver metastasis within 3 years in ovarian cancer patients with MLN involvement is 61.1%. However, ovarian cancer patients with bowel or liver involvement are susceptible to postoperative malnutrition due to their extensive surgery, as well as increased incidence of postoperative complications. Therefore, this study included patients who underwent bowel resection for ovarian cancer, and assessed the patients' MLN metastasis and nutritional status based on the relevant clinical indicators, in order to reduce the incidence of postoperative complications in patients with bowel resection, to improve the patients' prognosis, and to enhance the quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a non-interventional retrospective study to collect clinical data from patients with advanced epithelial ovarian cancer who underwent bowel surgery in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of the University of Science and Technology of China from January 2017 to December 2023. The information collected includes: age, preoperative body mass index (BMI), menopausal status, genetic test results, FIGO stage, type of bowel resection, duration of the operation, and depth of bowel infiltration, number of MLN resections, as well as nutritional status scores (NRS 2002 and PG-SGA), biochemical indices (serum albumin, prealbumin, total protein and so on), inflammatory indices (C-reactive protein, neutrophilic to lymphocyte ratio, platelet to lymphocyte ratio), and anthropometric parameters (body weight change, BMI). The aim of the clinical data analysis was to reduce the incidence of perioperative complications, improve the prognosis, and enhance the quality of life of patients with ovarian cancer after bowel surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Progression-Free Survival Overall Survival Nutrition Aspect of Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

This is an observational study and did not involve interventions.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with advanced epithelial ovarian cancer who underwent bowel surgery (PDS, IDS, and SCS);

* FIGO (2014) staging of stage III to IV;

* Diagnosis was made between January 2017 and December 2023; ④Complete relevant clinical data.

Exclusion Criteria

* Combination of malignant tumors in other parts of the body not in remission or under treatment; ②Having an infectious disease in the infectious or active stage;

* Unknown status of visits to other hospitals and loss of visits; ④Not considered by the investigator to be suitable for enrollment or incomplete baseline information.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ying Zhou, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anhui Provincal Hospital

Hefei, Anhui, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ying Zhou-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment Outcomes of Retroperitoneal Sarcoma
NCT06612671 ACTIVE_NOT_RECRUITING