Cervical CancerNCT07612865
People's Hospital of Xinjiang Uygur Autonomous Region
A study testing ERAS group in people with Cervical Cancer and Venous Thromboembolism, run by People's Hospital of Xinjiang Uygur Autonomous Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Venous Thromboembolism, Lymphedema
- What is being tested?
- ERAS group
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
About this study
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
- Being tested
- ERAS group
- Medical subject headings
- Uterine Cervical Neoplasms, Venous Thromboembolism, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: ERAS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (17)
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).
Measured: 6 months after surgery
Time to First Flatus
Number of hours from surgery completion to first passage of flatus, indicating recovery of gastrointestinal function.
Measured: Within 14 days after surgery (typically hours to days)
Time to First Defecation
Number of hours from surgery completion to first bowel movement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: Preoperative (baseline) vs. Postoperative day 3
Change in Prothrombin Time (PT)
Change in prothrombin time (PT) measured from fasting blood samples, reported in seconds.
Measured: Preoperative (baseline) vs. Postoperative day 3
Change in Hemoglobin (Hb)
Change in hemoglobin (Hb) measured from complete blood count, reported in g/L.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperative (baseline) vs. 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start5 Sep 2022
- Primary completion17 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Xinjiang Uygur Autonomous Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiumin Zhang, People's Hospital of Xinjiang Uygur Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612865
- Sponsor's protocol ID
- KY2022080503
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- People's Hospital of Xinjiang Uygur Autonomous Region
- ClinicalTrials.gov ID
- NCT07612865
- Acronym / sponsor ID
- KY2022080503
- Conditions
- Cervical Cancer, Venous Thromboembolism, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- People's Hospital of Xinjiang Uygur Autonomous RegionUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: ERAS groupIn 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS groupIn 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 | Behavioural | ERAS Multimodal Pathway |
Primary outcome
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.
17 secondary outcomes
Incidence of Postoperative Lower Limb Lymphedema
Time frame: 6 months after surgery
Time to First Flatus
Time frame: Within 14 days after surgery (typically hours to days)
Time to First Defecation
Time frame: Within 14 days after surgery (typically days)
Time to First Ambulation
Time frame: Within 7 days after surgery
Postoperative Length of Hospital Stay
Time frame: At hospital discharge, assessed up to 4 weeks postoperatively
Change in C-Reactive Protein (CRP)
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in D-Dimer (D-D)
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Platelet Count (PLT)
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Global Health Status / Quality of Life (QLQ-C30)
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Nursing Satisfaction
Time frame: At hospital discharge (postoperative day 7 to day 15)
Change in White Blood Cell Count (WBC)
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Prothrombin Time (PT)
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Hemoglobin (Hb)
Time frame: Preoperative (baseline) vs. Postoperative day 3
Change in Functional Scales (QLQ-C30)
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Change in Symptom Scales (QLQ-C30)
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Change in Single Items (QLQ-C30)
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Change in Total Score (QLQ-C30)
Time frame: Preoperative (baseline) vs. 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS group in people with Cervical Cancer and Venous Thromboembolism, run by People's Hospital of Xinjiang Uygur Autonomous Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Venous Thromboembolism (VTE) (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.