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Completed

NCT Number: NCT07612865

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS group

Behavioral

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

Primary outcomes

  1. Incidence of Postoperative Venous Thromboembolism (VTE)

    Time frame: 6 months after surgery

    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.

Secondary outcomes

  1. Incidence of Postoperative Lower Limb Lymphedema

    Time frame: 6 months after surgery

    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).

  2. Time to First Flatus

    Time frame: Within 14 days after surgery (typically hours to days)

    Number of hours from surgery completion to first passage of flatus, indicating recovery of gastrointestinal function.

  3. Time to First Defecation

    Time frame: Within 14 days after surgery (typically days)

    Number of hours from surgery completion to first bowel movement.

  4. Time to First Ambulation

    Time frame: Within 7 days after surgery

    Number of days from surgery completion to the first time the patient walks independently (assisted or unassisted) outside the bed area.

  5. Postoperative Length of Hospital Stay

    Time frame: At hospital discharge, assessed up to 4 weeks postoperatively

    Total number of days from the date of surgery to the date of hospital discharge.

  6. Change in C-Reactive Protein (CRP)

    Time frame: Preoperative (baseline) vs. Postoperative day 3

    Change in serum C-reactive protein (CRP) measured from fasting blood samples, reported in mg/L.

  7. Change in D-Dimer (D-D)

    Time frame: Preoperative (baseline) vs. Postoperative day 3

    Change in plasma D-dimer (D-D) measured from fasting blood samples, reported in mg/L.

  8. Change in Platelet Count (PLT)

    Time frame: Preoperative (baseline) vs. Postoperative day 3

    Change in platelet count (PLT) measured from complete blood count, reported in ×10⁹/L.

  9. Change in Global Health Status / Quality of Life (QLQ-C30)

    Time frame: Preoperative (baseline) vs. 6 months postoperatively

    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.

  10. Nursing Satisfaction

    Time frame: At hospital discharge (postoperative day 7 to day 15)

    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%.

  11. Change in White Blood Cell Count (WBC)

    Time frame: Preoperative (baseline) vs. Postoperative day 3

    Change in white blood cell count (WBC) measured from fasting blood samples, reported in ×10⁹/L.

  12. Change in Prothrombin Time (PT)

    Time frame: Preoperative (baseline) vs. Postoperative day 3

    Change in prothrombin time (PT) measured from fasting blood samples, reported in seconds.

  13. Change in Hemoglobin (Hb)

    Time frame: Preoperative (baseline) vs. Postoperative day 3

    Change in hemoglobin (Hb) measured from complete blood count, reported in g/L.

  14. Change in Functional Scales (QLQ-C30)

    Time frame: Preoperative (baseline) vs. 6 months postoperatively

    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.

  15. Change in Symptom Scales (QLQ-C30)

    Time frame: Preoperative (baseline) vs. 6 months postoperatively

    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.

  16. Change in Single Items (QLQ-C30)

    Time frame: Preoperative (baseline) vs. 6 months postoperatively

    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.

  17. Change in Total Score (QLQ-C30)

    Time frame: Preoperative (baseline) vs. 6 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

People's Hospital of Xinjiang Uygur Autonomous Region

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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