Objective: To evaluate the impact of enhanced recovery after surgery (ERAS)-based nursing intervention on venous thromboembolism (VTE) and lymphedema after radical hysterectomy for cervical cancer. Methods: In this prospective randomized controlled trial, 160 patients scheduled for radical hysterectomy during September 2022-September 2024 were randomized to an ERAS group (n = 80) or a control group (n = 80). The control group received conventional perioperative care, while the ERAS group received a multimodal perioperative care protocol. Primary outcomes were the 6-month incidence of VTE and lower limb lymphedema. Secondary outcomes included recovery indicators, inflammatory and coagulation markers, quality of life \[QoL; assessed by the Quality of Life Questionnaire-Core 30 (QLQ-C30)\], and nursing satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
In addition to conventional care, the ERAS group received a comprehensive intervention protocol based on ERAS principles, implemented by a dedicated ERAS nursing team. Details are as follows: Preoperative interventions: (1) Enhanced education and prehabilitation: Detailed explanation of the ERAS pathway, VTE and lymphedema prevention using graphics and videos. Instruction on ankle pump exercises and quadriceps isometric contractions. (2) Nutritional support: Nutritional risk assessment and provision of oral nutritional supplements if necessary. (3) Fasting management: No solid food for 6 hours, clear oral fluids (e.g., 200 mL of 10% glucose solution) allowed up to 2 hours preoperatively. Intraoperative interventions: (1) Thermoregulation: Use of forced-air warming blankets and fluid warmers to maintain core temperature \> 36°C. (2) Restrictive fluid management: Goal-directed fluid therapy to avoid excessive infusion. (3) Minimally invasive and meticulous surgery: Encouragement of laparo
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, China
Incidence of Postoperative Venous Thromboembolism (VTE)
Composite incidence of deep vein thrombosis (DVT) of the lower extremities and pulmonary embolism (PE). DVT is diagnosed by bilateral lower extremity venous color Doppler ultrasonography performed on postoperative day 3, before discharge, and at 1, 3, and 6 months postoperatively or when clinically indicated. PE is evaluated by computed tomography pulmonary angiography (CTPA) when clinically suspected.
Time frame: 6 months after surgery
Incidence of Postoperative Lower Limb Lymphedema
Diagnosis based on International Society of Lymphology criteria (Grade I: pitting edema relieved by elevation; Grade II: non-pitting edema with tissue fibrosis; Grade III: elephantiasis). Measured by bilateral calf circumference (thickest point) and thigh circumference (15 cm above patella).
Time frame: 6 months after surgery
Time to First Flatus
Number of hours from surgery completion to first passage of flatus, indicating recovery of gastrointestinal function.
Time frame: Within 14 days after surgery (typically hours to days)
Time to First Defecation
Number of hours from surgery completion to first bowel movement.
Time frame: Within 14 days after surgery (typically days)
Time to First Ambulation
Number of days from surgery completion to the first time the patient walks independently (assisted or unassisted) outside the bed area.
Time frame: Within 7 days after surgery
Postoperative Length of Hospital Stay
Total number of days from the date of surgery to the date of hospital discharge.
Time frame: At hospital discharge, assessed up to 4 weeks postoperatively
Change in C-Reactive Protein (CRP)
Change in serum C-reactive protein (CRP) measured from fasting blood samples, reported in mg/L.
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in D-Dimer (D-D)
Change in plasma D-dimer (D-D) measured from fasting blood samples, reported in mg/L.
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Platelet Count (PLT)
Change in platelet count (PLT) measured from complete blood count, reported in ×10⁹/L.
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Global Health Status / Quality of Life (QLQ-C30)
Change in the Global Health Status / Quality of Life subscale score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Minimum value: 0. Maximum value: 100. Higher scores indicate better quality of life.
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Nursing Satisfaction
Measured by the Newcastle Satisfaction with Nursing Scale (NSNS). Categorized as: highly satisfied, moderately satisfied, or not satisfied. Overall satisfaction rate = (highly satisfied + moderately satisfied) / total patients × 100%.
Time frame: At hospital discharge (postoperative day 7 to day 15)
Change in White Blood Cell Count (WBC)
Change in white blood cell count (WBC) measured from fasting blood samples, reported in ×10⁹/L.
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Prothrombin Time (PT)
Change in prothrombin time (PT) measured from fasting blood samples, reported in seconds.
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Hemoglobin (Hb)
Change in hemoglobin (Hb) measured from complete blood count, reported in g/L.
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Functional Scales (QLQ-C30)
Change in the Functional Scales composite score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Minimum value: 0. Maximum value: 100. Higher scores indicate better functional status.
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Change in Symptom Scales (QLQ-C30)
Change in the Symptom Scales composite score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Minimum value: 0. Maximum value: 100. Higher scores indicate worse symptom burden.
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Change in Single Items (QLQ-C30)
Change in the Single Items score (including dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Minimum value: 0. Maximum value: 100. Higher scores indicate worse symptom burden or greater financial difficulty.
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Change in Total Score (QLQ-C30)
Change in the total score from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Minimum value: 0. Maximum value: 100. Higher scores indicate better overall quality of life.
Time frame: Preoperative (baseline) vs. 6 months postoperatively
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