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RecruitingNCT07872150SEPSUpdated Oct 14, 2026

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

An interventional study of Subfascial Endoscopic Perforator Surgery(SEPS) and Open Perforator Ligation(Stab Avulsion) in Varicose Veins of Lower Limb, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 14, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Varicose Veins of Lower Limb
03

In context

Lead sponsor

King Edward Medical University is the lead sponsor of 80 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18-70 years.
  • Diagnosed with lower limb varicose veins with incompetent perforating veins confirmed by duplex ultrasonography.
  • CEAP clinical classification C4-C6 (advanced chronic venous insufficiency).
  • Fit for elective surgery under spinal or general anesthesia.

Exclusion criteria

Exclusion Criteria:

  • Recurrent varicose veins after previous interventions.
  • Deep vein thrombosis (DVT) or extensive deep venous obstruction.
  • Severe systemic comorbidities contraindicating surgery.
  • Patients unwilling to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Active comparator
    SubFascial Endoscopic Perforator 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.

    Procedure: Subfascial Endoscopic Perforator Surgery(SEPS)

  • Active comparator
    Open Perforator Ligation(Stab Avulsion)

    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.

    Procedure: Open Perforator Ligation(Stab Avulsion)

Interventions

  • ProcedureSubfascial Endoscopic Perforator Surgery(SEPS)

    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.

  • ProcedureOpen Perforator Ligation(Stab Avulsion)

    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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • King Edward Medical University(KEMU), Lahore
    Lahore, Punjab Province 54000, Pakistan
    • Muhammad Usman, MBBS · Contact · m.usman1320@gmail.com · +923124010222
    • Muhammad Usman, MBBS · Principal investigator
    Recruiting
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartActual
Jul 10, 2026
Primary completionEst.
Dec 25, 2026
CompletionEst.
Jan 1, 2027
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
eligibility
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 14, 2026
    Eligibility Criteria revised
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07872150
Lead sponsor
King Edward Medical University
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Jul 10, 2026
Primary completion
Dec 25, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Muhammad Usman, MBBS
Contact
m.usman1320@gmail.com
+923124010222
Muhammad Usman, MBBS
principal investigator · King Edward Medical University (KEMU) Lahore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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