Varicose Veins of Lower LimbSEPSNCT07872150
Subfascial Endoscopic Perforator Surgery (SEPS) Versus Open Ligation for Lower Limb Varicose Veins
A study testing Subfascial Endoscopic Perforator Surgery(SEPS) and Open Perforator Ligation(Stab Avulsion) in people with Varicose Veins of Lower Limb, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Subfascial Endoscopic Perforator Surgery(SEPS) and Open Perforator Ligation(Stab Avulsion)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University(KEMU), Lahore
Lahore, Punjab Province, 54000
Muhammad Usman, MBBS, +923124010222, m.usman1320@gmail.com
Muhammad Usman, MBBS
About this study
Official title: "COMPARATIVE OUTCOMES OF SUBFASCIAL ENDOSCOPIC PERFORATOR SURGERY (SEPS) VERSUS OPEN LIGATION FOR TREATING LOWER LIMB VARICOSITIES"
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.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Subfascial Endoscopic Perforator Surgery(SEPS), Open Perforator Ligation(Stab Avulsion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subfascial Endoscopic Perforator Surgery(SEPS)Procedure or 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 or 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
| Study group | Role | What they receive |
|---|---|---|
| SubFascial Endoscopic Perforator Surgery | Active comparator | 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. Receives: Procedure: Subfascial Endoscopic Perforator Surgery(SEPS) |
| Open Perforator Ligation(Stab Avulsion) | Active comparator | 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. Receives: Procedure: Open Perforator Ligation(Stab Avulsion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 and 2 months follow up
Secondary outcomes (3)
Recurrence of Lower Limb Varicosities
Presence of recurrent varicosities in the treated limb during follow-up after surgery.
Measured: 1 month
Postoperative Wound Complications
Occurrence of wound infection, wound dehiscence, hematoma, or delayed wound healing following surgery.
Measured: Within 30 days after surgery
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start10 Jul 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Usman, MBBS, Principal investigator, King Edward Medical University (KEMU) Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872150
- Sponsor's protocol ID
- 303/RC/KEMU/26 Muhammad Usman
- Acronym
- SEPS
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "COMPARATIVE OUTCOMES OF SUBFASCIAL ENDOSCOPIC PERFORATOR SURGERY (SEPS) VERSUS OPEN LIGATION FOR TREATING LOWER LIMB VARICOSITIES"
- ClinicalTrials.gov ID
- NCT07872150
- Acronym / sponsor ID
- SEPS / 303/RC/KEMU/26 Muhammad Usman
- Conditions
- Varicose Veins of Lower Limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SubFascial Endoscopic Perforator Surgery | Active comparator | Procedure: Subfascial 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. |
| Open Perforator Ligation(Stab Avulsion) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Subfascial 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. | Procedure or surgery | SubFascial Endoscopic Perforator Surgery |
| 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 or surgery | Open Perforator Ligation(Stab Avulsion) |
Primary outcome
Venous Clinical Severity Score
Time frame: 1 and 2 months follow up
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.
3 secondary outcomes
Recurrence of Lower Limb Varicosities
Time frame: 1 month
Postoperative Wound Complications
Time frame: Within 30 days after surgery
Visual Analogue Scale for Pain
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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.
Muhammad Usman, MBBS principal investigator
King Edward Medical University (KEMU) Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subfascial Endoscopic Perforator Surgery(SEPS) and Open Perforator Ligation(Stab Avulsion) in people with Varicose Veins of Lower Limb, run by King Edward Medical University at 1 site in Pakistan.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Oct 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Usman, MBBS (+923124010222, m.usman1320@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Clinical Severity Score (time frame: 1 and 2 months follow up). 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 14 Oct 2026.