Clinical trial NCT06527001: Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer
Official title: Retrospective Analysis of Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Progression-Free Survival
Overall Survival
Nutrition Aspect of Cancer
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-30
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS
timeFrame: 2 year
measure: OS
timeFrame: 2 year
measure: NRS 2002
timeFrame: The scale was evaluated before surgery and at 4 months after surgery.
measure: PG-SGA
timeFrame: The scale was evaluated before surgery and at 4 months after surgery.
measure: BMI
timeFrame: The index was evaluated before surgery and at 4 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Ying Zhou, MD
role: STUDY_CHAIR
References: