Effect of Early Enteral Nutrition on Postoperative Recovery of Ovarian Cancer Patients

Recruiting

• Conditions: Advanced Epithelial Ovarian Cancer

• Registration Number: NCT06236958
• Lead Sponsor: Luo Chengyan

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.

Study Timeline

• Study First Submitted: 2023-11-23
• Study Start: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life scores	postoperative days 3	To assess patients' quality of life scores on postoperative day 3 according to functional assessment of cancer therapy-ovary cancer (FACT-O) vision 4.0, with a minimum value of 0 and a maximum value of 156. The higher scores are, the better quality of postoperative survival is.
Serum sodium and potassium	postoperative days 7, and 14	To record the patient's serum sodium and potassium on postoperative days 7 and 14 according to biochemical results.
Abnormal liver function	postoperative days 7, and 14	To record the number of patients with abnormal liver function within 30 days postoperatively according to biochemical results. Abnormal liver function was defined as serum alanine aminotransferase and/or aspartate aminotransferase higher than 2.5 times the upper limit of normal values.
Serum albumin	postoperative days 7, and 14	To record the patient's serum albumin on postoperative days 7 and 14 according to biochemical results.
Intervals from surgery to the initiation of postoperative exhaustion and defecation	one month after surgery	To record intervals from surgery to the initiation of postoperative exhaustion and defecation according to the medical record
The hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy	one month after surgery	To record the hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy according to the medical record
Incidence of complications postoperative complications	one month after surgery	To record the incidence of complications patient's postoperative complications for 30 days according to medical records, including: fever, intestinal obstruction, intestinal fistula, thrombosis, pulmonary embolism, poor incision healing, etc.
Hemoglobin	postoperative days 7, and 14	To record the patient's hemoglobin on postoperative days 7 and 14 according to routine blood results
The cost of hospitalization of peri operation	one month after surgery	To record the cost of a patient's hospitalization of peri operation according to the medical record
Abnormal renal function	postoperative days 7, and 14	To record the number of patients with abnormal renal function within 30 days postoperatively according to biochemical results. Abnormal renal function was defined as serum creatinine and/or urea higher than 2.5 times the upper limit of normal values.

Secondary Outcome Measures

Name	Time	Method
Survival outcomes	three years after surgery	Survival outcomes at 3 years postoperatively, including progression, recurrence, death, and survival
Incidence of complications related to nasojejunal tubes	one month after surgery	To record the incidence of complications related to tube placement in patients in the nasojejunal group according to medical records

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital); 🇨🇳 Nanjing, Jiangsu, China