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

NCT06527001 | Active Not Recruiting

• 1 other identifier: Ying Zhou-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Progression-Free Survival; Overall Survival; Nutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (5)

• PFS

  PFS is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.

  2 year

• OS

  OS was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.

  2 year

• NRS 2002

  Nutritional Risk Screening 2002 (NRS 20002) was primarily used to assess a patient's possible nutritional risk, and a score of ≥3 indicates that the patient is at risk of malnutrition or nutritional risk.

  The scale was evaluated before surgery and at 4 months after surgery.

• PG-SGA

  Patient-Generated Subjective Global Assessment (PG-SGA) was primarily used to assess the nutritional status of tumor patients. Well nourished was 0-1 score, suspected or mild malnutrition was 2-3 score, moderate malnutrition was 4-8 score, severe malnutrition ≥9 score.

  The scale was evaluated before surgery and at 4 months after surgery.

• BMI

  Body mass index (BMI) was obtained by dividing weight in kilograms by height in meters squared. Normal was 18.5-24 score, overweight was 24-28 score, and obesity ≥28 score.

  The index was evaluated before surgery and at 4 months after surgery.

Interventions

No intervention OTHER

This is an observational study and did not involve interventions.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.All enrolled patients underwent cytoreductive surgery and completed follow-up registration according to NCCN guidelines.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincal Hospital

Hefei, Anhui, 230000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual Blood

Study Officials

• Ying Zhou, MD

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: June 16, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)