An observational study in Advanced Epithelial Ovarian Cancer, sponsored by Luo Chengyan. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Luo Chengyan · Observational
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
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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.
Exclusion Criteria:
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
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 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.
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.
Hemoglobin
To record the patient's hemoglobin on postoperative days 7 and 14 according to routine blood results
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: postoperative days 7, and 14
Serum albumin
To record the patient's serum albumin on postoperative days 7 and 14 according to biochemical results.
Time frame: postoperative days 7, and 14
Survival outcomes
Survival outcomes at 3 years postoperatively, including progression, recurrence, death, and survival
Time frame: 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
Time frame: one month after surgery
Plan to share: No
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