Recurrent Varicose Vein of Lower Limb (Disorder)NCT05693350
Etiology Of Recurrent Varicose Veins After Stripping Or Ablation Of Superficial Venous System
An observational study of Recurrent Varicose Vein of Lower Limb (Disorder), run by Assiut University.
Trial summary
Number of patients and causes and patterns of recurrent varicose veins in the lower limbs in patients with history of varicose veins stripping or ablation of the superficial venous system. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recurrent Varicose Vein of Lower Limb (Disorder)
- What is being tested?
- DUS
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Jan 2025
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with previous history of intervention for varicose veins
Who may be able to join
- 1) Ages eligible for the study: 18-60. 2) Sexes eligible for the study: All. 3) Patients with previous intervention for varicose veins. 4) Patients with primary or secondary varicosities. 5) Patient's compliance to follow-up.
Who cannot join
- 1) Patients with no history of interventions for varicose veins. 2) Patients treated with injection sclerotherapy alone. 3) Pregnant women. 4) Patients with arterial disease in the same limb (ABI <0.8). 5) Patients with post-thrombotic syndrome
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Etiology Of Recurrent Varicose Veins After Stripping Or Ablation Of Superficial
Number of patients and causes and patterns of recurrent varicose veins in the lower limbs in patients with history of varicose veins stripping or ablation of the superficial venous system.
Read the detailed description
Recurrence of varicose veins following surgery is a common, complex and costly problem in vascular surgery. Despite improvements in preoperative evaluation and methods of treatment, recurrence following varicose vein surgery is reported to occur in between 20 and 80% of cases. Many theories have been put forward concerning the underlying mechanisms and causes. These include poor understanding of the venous anatomy and haemodynamics, inadequate preoperative assessment, inappropriate or incomplete surgery and development of new sites of venous reflux as a consequence of disease progression or neovascularisation. However, it is difficult to evaluate these suggestions since the studies from which they arise vary greatly in their definitions of recurrence, preoperative assessment, initial treatment, classification and method and duration of follow-up.
- Being tested
- DUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUSDiagnostic test
Duplex ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiology of recurrence of varicose veins in patients previously treated by stripping and ligation or endovenous ablation.
Track the recurrence of varicose veins after intervention
Measured: Five years
Secondary outcomes (1)
Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ)
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent Varicose Vein of Lower Limb (Disorder)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tarek Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693350
- Sponsor's protocol ID
- Recurrent Varicose Veins
- Status last verified
- Jan 2023
- First submitted
- 2 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kostas T, Ioannou CV, Touloupakis E, Daskalaki E, Giannoukas AD, Tsetis D, Katsamouris AN. Recurrent varicose veins after surgery: a new appraisal of a common and complex problem in vascular surgery. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):275-82. doi: 10.1016/j.ejvs.2003.12.006.
PubMed 14760596Blomgren L, Johansson G, Dahlberg-AKerman A, Noren A, Brundin C, Nordstrom E, Bergqvist D. Recurrent varicose veins: incidence, risk factors and groin anatomy. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):269-74. doi: 10.1016/j.ejvs.2003.12.022.
PubMed 14760595Hamdan A. Management of varicose veins and venous insufficiency. JAMA. 2012 Dec 26;308(24):2612-21. doi: 10.1001/jama.2012.111352.
PubMed 23268520
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology Of Recurrent Varicose Veins After Stripping Or Ablation Of Superficial
- ClinicalTrials.gov ID
- NCT05693350
- Acronym / sponsor ID
- Recurrent Varicose Veins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 23 Jan 2023 (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.
Number of patients and causes and patterns of recurrent varicose veins in the lower limbs in patients with history of varicose veins stripping or ablation of the superficial venous system.
Detailed description
Recurrence of varicose veins following surgery is a common, complex and costly problem in vascular surgery. Despite improvements in preoperative evaluation and methods of treatment, recurrence following varicose vein surgery is reported to occur in between 20 and 80% of cases. Many theories have been put forward concerning the underlying mechanisms and causes. These include poor understanding of the venous anatomy and haemodynamics, inadequate preoperative assessment, inappropriate or incomplete surgery and development of new sites of venous reflux as a consequence of disease progression or neovascularisation. However, it is difficult to evaluate these suggestions since the studies from which they arise vary greatly in their definitions of recurrence, preoperative assessment, initial treatment, classification and method and duration of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with previous history of intervention for varicose veins
Key inclusion criteria (1 listed)
- 1) Ages eligible for the study: 18-60. 2) Sexes eligible for the study: All. 3) Patients with previous intervention for varicose veins. 4) Patients with primary or secondary varicosities. 5) Patient's compliance to follow-up.
Key exclusion criteria (2 listed)
- 1) Patients with no history of interventions for varicose veins. 2) Patients treated with injection sclerotherapy alone. 3) Pregnant women. 4) Patients with arterial disease in the same limb (ABI <0.8). 5) Patients with post-thrombotic syndrome
- -
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 |
|---|---|---|
| DUSDuplex ultrasound | Diagnostic test | – |
Primary outcome
Etiology of recurrence of varicose veins in patients previously treated by stripping and ligation or endovenous ablation.
Time frame: Five years
Track the recurrence of varicose veins after intervention
1 secondary outcome
Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Background: PubMed 14760596Kostas T, Ioannou CV, Touloupakis E, Daskalaki E, Giannoukas AD, Tsetis D, Katsamouris AN. Recurrent varicose veins after surgery: a new appraisal of a common and complex problem in vascular surgery. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):275-82. doi: 10.1016/j.ejvs.2003.12.006.
- Background: PubMed 14760595Blomgren L, Johansson G, Dahlberg-AKerman A, Noren A, Brundin C, Nordstrom E, Bergqvist D. Recurrent varicose veins: incidence, risk factors and groin anatomy. Eur J Vasc Endovasc Surg. 2004 Mar;27(3):269-74. doi: 10.1016/j.ejvs.2003.12.022.
- Background: PubMed 23268520Hamdan A. Management of varicose veins and venous insufficiency. JAMA. 2012 Dec 26;308(24):2612-21. doi: 10.1001/jama.2012.111352.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Varicose Vein of Lower Limb (Disorder), run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Tarek Mostafa, Resident doctor (01116697331 ext. 002, mtarekmostafa96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Etiology of recurrence of varicose veins in patients previously treated by stripping and ligation or endovenous ablation. (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693350, which also lists 3 linked publications.
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 23 Jan 2023.