People's Hospital of Xinjiang Uygur Autonomous Region

NCT07612865 | Completed

• 1 other identifier: KY2022080503
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Cervical Cancer; Venous Thromboembolism; Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Incidence of Postoperative Lower Limb Lymphedema

  6 months after surgery

• Time to First Flatus

  Within 14 days after surgery (typically hours to days)

• Time to First Defecation

  Within 14 days after surgery (typically days)

• Time to First Ambulation

  Within 7 days after surgery

• Postoperative Length of Hospital Stay

  At hospital discharge, assessed up to 4 weeks postoperatively

Study Arms (2)

Conventional Perioperative Care

NO INTERVENTION

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.

ERAS Multimodal Pathway

EXPERIMENTAL

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

Interventions

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

ERAS Multimodal Pathway

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

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

Study Sites (1)

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Venous Thromboembolism; Lymphedema

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start: September 5, 2022
• Primary Completion: September 17, 2024
• Study Completion: September 26, 2024
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CN (1)