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Subfascial Endoscopic Perforator Surgery (SEPS) Versus Open Ligation for Lower Limb Varicose Veins

ConditionVaricose Veins of Lower Limb
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKing Edward Medical University

About this trial

The goal of this study is to compare two surgical treatments for lower limb varicose veins: subfascial endoscopic perforator surgery (SEPS) and open perforator ligation. Patients undergoing treatment for lower limb varicose veins will receive one of these surgical procedures. The study will compare postoperative outcomes, recovery, and complications between the two groups to determine which surgical approach provides better outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subfascial Endoscopic Perforator Surgery(SEPS)

    Procedure/Surgery

    Participants in this group will undergo subfascial endoscopic perforator surgery (SEPS) for treatment of incompetent perforator veins associated with lower limb varicosities. The procedure involves endoscopic identification and division of incompetent perforating veins through small incisions, with the aim of reducing venous reflux and improving clinical outcomes.

  • Open Perforator Ligation(Stab Avulsion)

    Procedure/Surgery

    Participants in this group will undergo conventional open surgical ligation(Stab Avulsion) and division of incompetent perforating veins for treatment of lower limb varicosities. The clinical and postoperative outcomes will be compared with those of participants undergoing SEPS

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: SubFascial Endoscopic Perforator SurgeryActive comparator 1 intervention
Group B: Open Perforator Ligation(Stab Avulsion)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Venous Clinical Severity Score

Change in Venous Clinical Severity Score (VCSS) from baseline to postoperative follow-up will be assessed to compare clinical improvement between patients undergoing subfascial endoscopic perforator surgery and open perforator ligation.

Time frame
1 and 2 months follow up

Secondary outcomes

1

Recurrence of Lower Limb Varicosities

Presence of recurrent varicosities in the treated limb during follow-up after surgery.

Time frame
1 month
2

Postoperative Wound Complications

Occurrence of wound infection, wound dehiscence, hematoma, or delayed wound healing following surgery.

Time frame
Within 30 days after surgery
3

Visual Analogue Scale for Pain

Postoperative pain will be assessed using the Visual Analogue Scale (VAS), with pain intensity recorded at follow-up and compared between the subfascial endoscopic perforator surgery and open perforator ligation groups.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Edward Medical University

Lead sponsor

Source ClinicalTrials.gov
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