Clinical trial NCT06236958: Effect of Early Enteral Nutrition on Postoperative Recovery of Ovarian Cancer Patients
Official title: Clinical Study on the Effect of Early Enteral Nutrition Implemented by Placing Nasojejunal Tube During Ovarian Cancer Surgery on Patients' Postoperative Recovery and Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Epithelial Ovarian Cancer
Keywords: Enteral Nutrition, Nasojejunal tube
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the Department of Gynecology of the First Affiliated Hospital of Nanjing Medical University, aged 18-75 years old, with a definitive diagnosis of epithelial ovarian cancer by pathology, preoperative imaging, and intraoperative visual judgment of tumor involvement in organs other than the pelvic cavity, and FIGO Stage III or above, and proposed to undergo cytoreductive treatment of ovarian tumors.

Brief summary: This is a single-center, unblinded, prospective observational study, and the objective is to compare the effects of enteral nutrition via nasojejunal tube and parenteral nutrition via vein on patients' early recovery and prognosis who undergo tumor cytoreduction for ovarian cancer.

Detailed description: Ovarian cancer is the most lethal disease among gynecological malignancies, and its treatment is a comprehensive one mainly based on surgery. The perioperative nutritional status of patients affects their postoperative recovery, subsequent adjuvant therapy, and their prognosis. Hence, nutritional support therapy should be initiated for such patients in the early postoperative period to prevent further malnutrition. Conventional postoperative nutritional support therapy is performed through parenteral nutrition via vein, while the application of enteral nutrition via the nasojejunal tube in the postoperative period of ovarian cancer has not been reported in the literature. Therefore, in this study, the investigators took advantage of the characteristics of long surgical incisions and the wide surgical scope of ovarian cancer to investigate the effects of placing a nasojejunal tube during the operation and early enteral nutrition on postoperative recovery and prognosis in patients with advanced ovarian cancer, with the aim of accelerating the postoperative recovery of the patients, decreasing the incidence of postoperative complications, supplementing adjuvant chemotherapy in time, improving the survival outcome of the patients with advanced ovarian cancer, and providing gynecologists with a basis for enteral nutritional support therapy via nasojejunal tube after ovarian cancer surgery. In this study, the patients placed with a nasojejunal tube during the operation and enteral nutrition after the operation were included in the observation group, and the patients without a nasojejunal tube and parenteral nutrition after the operation were included in the control group. And the two groups were compared in terms of the indicators of postoperative recovery, the incidence of complications within the 30 days after operation, the cost of hospitalization, hospital stay, the interval between the operation and the first chemotherapy, the survival outcome, etc. The data involved in the study came from patient files, hospital databases, and long-term follow-up results.

Eligibility criteria: Inclusion Criteria:

* (1) The age is more than 18 years old and not more than 75 years old; (2) Ovarian cancer patients who are clearly diagnosed as epithelial ovarian cancer by pathological examination, whose tumors involve organs other than the pelvis as determined by preoperative imaging and intraoperative visual judgment, and who are at FIGO stage III or IV, and who undergo tumor cytoreductive surgery; (3) Patients without contraindication to nasoenteric tube placement and enteral nutrition; (4) Patients and their families were informed of the significance of the early use of enteral nutrition, precautions, adverse reactions, etc., before the operation, and they gave informed consent to this study and signed the informed consent; (5) Patients who received treatment in our hospital with complete clinical data.

Exclusion Criteria:

* (1) Patients with intestinal obstruction, severe intestinal infection, severe diarrhea, and acute abdomen right before surgery; (2) Patients with esophagogastric fundal varices and active gastrointestinal bleeding right before surgery; (3) Patients who undergo surgery to simultaneously resect the intestinal canal in the area more than 15cm distal to the ligament of Traitz; (4) Patients with severe cardiac, hepatic, and renal failure; (5) Patients with severe rhinitis, nasal mucous membrane damage, bleeding; (6) Patients with other malignant tumors combined within 3 months before surgery; (7) Metastatic ovarian cancer; (8) Those with missing clinical information; (9) Those with known hypersensitivity to enteral nutrition preparations.

Primary outcomes:
measure: Hemoglobin
timeFrame: postoperative days 7, and 14
measure: Intervals from surgery to the initiation of postoperative exhaustion and defecation
timeFrame: one month after surgery
measure: The hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy
timeFrame: one month after surgery
measure: The cost of hospitalization of peri operation
timeFrame: one month after surgery
measure: Incidence of complications postoperative complications
timeFrame: one month after surgery
measure: Quality of life scores
timeFrame: postoperative days 3
measure: Serum sodium and potassium
timeFrame: postoperative days 7, and 14
measure: Abnormal liver function
timeFrame: postoperative days 7, and 14
measure: Abnormal renal function
timeFrame: postoperative days 7, and 14
measure: Serum albumin
timeFrame: postoperative days 7, and 14
Secondary outcomes:
measure: Survival outcomes
timeFrame: three years after surgery
measure: Incidence of complications related to nasojejunal tubes
timeFrame: one month after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
name: Luo Chengyan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: