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People's Hospital of Xinjiang Uygur Autonomous Region

NCT07612865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • People's Hospital of Xinjiang Uygur Autonomous Region

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2024-09-17
Completion
2024-09-26

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612865 on ClinicalTrials.gov