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

Clinical Study on the Effect of Early Enteral Nutrition Implemented by Placing Nasojejunal Tube During Ovarian Cancer Surgery on Patients' Postoperative Recovery and Prognosis

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Epithelial Ovarian Cancer
• Intervention / Treatment: Device: Transnasal jejunal tube; Other: Transvenous access

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Luo Chengyan, Doctor; Phone Number: 13914751661; Email: betteryuan66@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
      • Contact: Luo Chengyan, Doctor; Phone Number: 13914751661; Email: betteryuan66@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transnasal jejunal tube enteral nutrition group; Naso-jejunal tube was placed to the distal 15cm of Traitz ligament during the operation; short peptide enteral nutrient solution was heated by enteral nutrition pump and infused slowly and continuously 24 hours after the operation; during the period of infusion, the gastrointestinal tolerance of the patients was evaluated dynamically, and attention was paid to the absence of abdominal pain, diarrhea, constipation, vomiting, regurgitation, and misaspiration. According to the results of regular review of nutritional indicators, including hemoglobin, albumin, electrolytes, liver and kidney function, etc., increase the dosage of enteral nutrients in patients in appropriate amounts; patients with no abdominal distension after exhaustion and fluid intake, that is, the removal of nasojejunal tube, and replaced by oral intake of food.	Device: Transnasal jejunal tube; A naso-jejunal tube was placed in the operation, which is placed 15 cm below Traitz's ligament. A short-peptide enteral nutrient solution was heated by an enteral nutrient pump and infused into the patients within 24 hours after the operation. Before and at the end of the infusion, physiological saline was given to flush the tube, and at the end of the infusion, the catheter was closed to prevent liquid reflux and blockage of the tube. The catheter should be clamped shut at the end of the infusion. During the infusion period, the patient's gastrointestinal tolerance was dynamically evaluated. According to the results of a regular review of nutritional indicators, including hemoglobin, albumin, electrolytes, liver and kidney function, etc., increase the amount of enteral nutrients; remove the nasojejunal tube when the patient has no abdominal distension after exhaustion and feeding; and change to feeding through the mouth.
Transvenous parenteral nutrition group; Nutrient solution was evenly titrated starting 24 hours after surgery. Configuration of nutritional solution: glucose and medium/long-chain fat emulsion as the main energy substances to provide calories, diabetic patients depending on the blood glucose level to adjust the pancreatic glucose ratio, and then assisted by subcutaneous injection of insulin to control blood glucose, if necessary, pay attention to the total amount of rehydration fluids, electrolytes, vitamins and micronutrient supplementation. Nutritional solution was evenly mixed in the laminar flow clean table and infused through the intravenous route, and oral feeding was started after exhaustion.	Other: Transvenous access; A uniform drip of nutritional solution was started 24 hours postoperatively. Configuration of nutritional solution: glucose and medium/long-chain fat emulsion as the main energy substances to provide calories, calculated at 30 ~ 35 kcal/(kg-d), glucose-fat ratio is 6:4, pancreatic glucose ratio for those without a history of diabetes mellitus is 1:6 ~ 8, and for diabetic patients depending on the level of glucose, pancreatic glucose ratio is 1:3 ~ 4, and then assisted with subcutaneous injections of insulin to control glucose, if necessary. Pay attention to the total amount of rehydration fluid, electrolytes, vitamins, and trace elements supplemented. Mix the nutrient solution evenly in the laminar flow clean table and infuse it through the route at 2500~3000 ml/d; the infusion time is 8~12 h/d. After exhaustion, start to eat through the mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	To record the patient's hemoglobin on postoperative days 7 and 14 according to routine blood results	postoperative days 7, and 14
Intervals from surgery to the initiation of postoperative exhaustion and defecation	To record intervals from surgery to the initiation of postoperative exhaustion and defecation according to the medical record	one month after surgery
The hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy	To record the hospital stay after surgery and intervals from surgery to initiation of postoperative chemotherapy according to the medical record	one month after surgery
The cost of hospitalization of peri operation	To record the cost of a patient's hospitalization of peri operation according to the medical record	one month after surgery
Incidence of complications postoperative complications	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.	one month after surgery
Quality of life scores	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.	postoperative days 3
Serum sodium and potassium	To record the patient's serum sodium and potassium on postoperative days 7 and 14 according to biochemical results.	postoperative days 7, and 14
Abnormal liver function	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.	postoperative days 7, and 14
Abnormal renal function	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.	postoperative days 7, and 14
Serum albumin	To record the patient's serum albumin on postoperative days 7 and 14 according to biochemical results.	postoperative days 7, and 14

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Luo Chengyan
• Investigators: Principal Investigator: Luo Chengyan, Doctor, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Enteral Nutrition, Nasojejunal tube
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 2023-SR-499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No