People's Hospital of Xinjiang Uygur Autonomous Region

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 Overview

• Status: Completed
• Conditions: Cervical Cancer; Lymphedema; Venous Thromboembolism
• Intervention / Treatment: Behavioral: ERAS group

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
      • People's Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• . Pathologically confirmed cervical cancer (FIGO 2018) 2. Age 18-70 years 3. First-time radical hysterectomy 4. ASA physical status class I-II 5. Perioperative anticoagulant prophylaxis per hospital standards 6. Provision of informed consent

Exclusion Criteria:

• 1. Pre-existing lower extremity DVT, lymphedema, or severe varicose veins 2. Severe cardiac, hepatic, or renal dysfunction or coagulation disorders 3. History of psychiatric illness or communication barriers 4. Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Perioperative Care; The control group received conventional perioperative care. This included routine preoperative education, fasting for 12 hours and no oral intake for 6 hours preoperatively, standard intraoperative fluid administration, postoperative patient-controlled analgesia pump, ambulation guided by traditional instructions (typically 1-2 days postoperatively), and initiation of liquid diet after passing flatus.
Experimental: ERAS Multimodal Pathway; 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 lapar	Behavioral: ERAS group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months after surgery
Time to First Flatus	Number of hours from surgery completion to first passage of flatus, indicating recovery of gastrointestinal function.	Within 14 days after surgery (typically hours to days)
Time to First Defecation	Number of hours from surgery completion to first bowel movement.	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.	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.	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.	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.	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.	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.	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%.	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.	Preoperative (baseline) vs. Postoperative day 3
Change in Prothrombin Time (PT)	Change in prothrombin time (PT) measured from fasting blood samples, reported in seconds.	Preoperative (baseline) vs. Postoperative day 3
Change in Hemoglobin (Hb)	Change in hemoglobin (Hb) measured from complete blood count, reported in g/L.	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.	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.	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.	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.	Preoperative (baseline) vs. 6 months postoperatively

Collaborators and Investigators

• Sponsor: People's Hospital of Xinjiang Uygur Autonomous Region

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): September 17, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Vascular Diseases; Cardiovascular Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Embolism and Thrombosis; Genital Neoplasms, Female; Lymphatic Diseases; Uterine Cervical Diseases; Uterine Neoplasms; Thromboembolism; Hemic and Lymphatic Diseases; Lymphedema; Uterine Cervical Neoplasms; Venous Thromboembolism
• Other Study ID Numbers: KY2022080503

Drug and device information, study documents

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