NCT04479956

Brief Summary

The authors will aim to compare microwave therapy with other lines of management radio-frequency ablation, Laser ablation and surgical ligation; regarding time to recurrence rate, ulcer-free time, and health-related quality of life. In a randomized controlled study,The study will be conducted at the department of vascular surgery in Mansoura university hospitals

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 17, 2020

Last Update Submit

July 17, 2020

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

  • Great Saphenous vein patency

    Lack of flow or closed great saphenous vein

    6 months

  • Operation Time

    The time of the whole procedure

    intraoperative

Secondary Outcomes (2)

  • Recurrence varicose vein

    12 Months

  • Adverse effect of the procedure

    12 Months

Study Arms (4)

Surgical Ligation

EXPERIMENTAL

Conventional surgical procedures will carried out through a 3-4 cm incision in the groin. The trunk of GSV and the tributaries will be ligated and divided.

Procedure: Varicose vein surgery

Microwave group

EXPERIMENTAL

The microwave treating wire (Microwave Intracavity Coagulation System; Shanghai Medical Electronics, Shanghai, China) will be inserted into the GSV until it reached the medial aspect of ankle, guided by a light that illuminated the tip of the wire. Then, GSV will be ablated using pulse mode at 20-30 W. The treating wire will be withdrawn at 2-4 mm/s, with the ablation time lasting 2 s (energy delivery to the GSV was estimated at around 80 J/cm); the treatment parameters will be based on a previous report. Tumescence will be used in all patients with 0.9% saline containing 20 mL 2% lidocaine with 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L 0.9% saline.

Procedure: Varicose vein surgery

Laser ablation group

EXPERIMENTAL

Endovenous Laser Ablation (EVLA) uses a laser Fiber, which is inserted into the abnormal vein via a small skin puncture.using 1470 nm laser and a "radial" fiber for less discomfort. Two weeks later the "branch vessels" have reduced in size

Procedure: Varicose vein surgery

Radiofrequency ablation group

EXPERIMENTAL

inserts a small catheter into the diseased vein through a small incision, using ultrasound guidance for an accurate and live view. Consistent and uniform heat is delivered to contract the collagen in the vein walls, causing them to collapse and close. After the vein is closed the treated vein is gradually absorbed into surrounding tissue.

Procedure: Varicose vein surgery

Interventions

Varicose vein surgeryPROCEDURE

sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee

Laser ablation groupMicrowave groupRadiofrequency ablation groupSurgical Ligation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary symptomatic VVS (CEAP, C3 , C6),
  • Sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee

You may not qualify if:

  • A history of venous surgery, suspected or proven deep venous thrombosis,
  • Reflux of deep veins to distal limb
  • Duplication of GSV
  • Patients' refusal to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura

Al Mansurah, Mansoura University, 35111, Egypt

RECRUITING

Mansoura University Hospital

Al Mansurah, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Computer Based
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized controlled Prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 21, 2020

Study Start

June 18, 2020

Primary Completion

June 18, 2021

Study Completion

October 30, 2021

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)