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A clinical trial to compare results of saphenous vein graft from thigh versus tongue mucosal graft use during urethral stricture surgery in male patients, who also have oral submucous fibrosis.

Comparision of surgical outcome and donor-site morbidity between everted great saphenous vein graft versus lingual muscosal graft use during substitution urethrosplasty in male patients of anterior urethral strictures along with oral submucous fibrosis: A randomized, open label, parallel group clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034096
Enrollment
50
Registered
2021-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K135- Oral submucous fibrosis Health Condition 3: N35- Urethral stricture

Interventions

Intervention1: Substitution urethroplasty using everted great saphenous vein graft (eGSV): Graft for urethroplasty surgery will be taken from either left or right thigh. Control Intervention1: Substit

Sponsors

Dr Deepak Kumar Biswal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients aged between 18-75 years. 2. Planned for substitution urethroplasty for anterior urethral stricture >2cm length. 3. Oral submucosal fibrosis with history of oral tobacco/ areca nut use.

Exclusion criteria

Exclusion criteria: 1. Previous history of urethroplasty. 2. History of deep vein thrombosis or venous insufficiency in lower limbs. 3. Near-obliterative strictures (urethral caliber 4. Presence of two separate strictures requiring separate grafts. 5. Body Mass Index (BMI) >=30. 6. Patients who refuse/ withdraw from the study.

Design outcomes

Primary

MeasureTime frame
1. To compare surgical outcome between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis. 2. To compare graft harvest site related morbidities between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis.Timepoint: Day-1 Day-3 Day-5 1-Month 3-Month 6-Month 1-Year—

Secondary

MeasureTime frame
1. To compare erectile function between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis.Timepoint: 1-Month 3-Month 6-Month 1-Year—

Countries

India

Contacts

Public ContactDr Deepak Kumar Biswal

All India Institute of Medical Sciences, Raipur (C.G.), India.

dr.deepakbiswal1@gmail.com8820257946

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026