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People's Hospital of Xinjiang Uygur Autonomous Region

25 maggio 2026 aggiornato da: Xiumin Zhang, 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

160

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Postoperative Venous Thromboembolism (VTE)
Lasso di tempo: 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.
6 months after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Postoperative Lower Limb Lymphedema
Lasso di tempo: 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).
6 months after surgery
Time to First Flatus
Lasso di tempo: 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.
Within 14 days after surgery (typically hours to days)
Time to First Defecation
Lasso di tempo: Within 14 days after surgery (typically days)
Number of hours from surgery completion to first bowel movement.
Within 14 days after surgery (typically days)
Time to First Ambulation
Lasso di tempo: 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.
Within 7 days after surgery
Postoperative Length of Hospital Stay
Lasso di tempo: At hospital discharge, assessed up to 4 weeks postoperatively
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)
Lasso di tempo: Preoperative (baseline) vs. Postoperative day 3
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)
Lasso di tempo: Preoperative (baseline) vs. Postoperative day 3
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)
Lasso di tempo: Preoperative (baseline) vs. Postoperative day 3
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)
Lasso di tempo: 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.
Preoperative (baseline) vs. 6 months postoperatively
Nursing Satisfaction
Lasso di tempo: 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%.
At hospital discharge (postoperative day 7 to day 15)
Change in White Blood Cell Count (WBC)
Lasso di tempo: Preoperative (baseline) vs. Postoperative day 3
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)
Lasso di tempo: Preoperative (baseline) vs. Postoperative day 3
Change in prothrombin time (PT) measured from fasting blood samples, reported in seconds.
Preoperative (baseline) vs. Postoperative day 3
Change in Hemoglobin (Hb)
Lasso di tempo: Preoperative (baseline) vs. Postoperative day 3
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)
Lasso di tempo: 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.
Preoperative (baseline) vs. 6 months postoperatively
Change in Symptom Scales (QLQ-C30)
Lasso di tempo: 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.
Preoperative (baseline) vs. 6 months postoperatively
Change in Single Items (QLQ-C30)
Lasso di tempo: 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.
Preoperative (baseline) vs. 6 months postoperatively
Change in Total Score (QLQ-C30)
Lasso di tempo: 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.
Preoperative (baseline) vs. 6 months postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

People's Hospital of Xinjiang Uygur Autonomous Region

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 settembre 2022

Completamento primario (Effettivo)

17 settembre 2024

Completamento dello studio (Effettivo)

26 settembre 2024

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY2022080503

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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