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CTRI Number  CTRI/2021/06/034096 [Registered on: 08/06/2021] Trial Registered Prospectively
Last Modified On: 30/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Kumar Biswal 
Designation  Assistant Professor, Department of Urology 
Affiliation  All India Institute of Medical Sciences, Raipur (C.G.), India. 
Address  Department of Urology, AIIMS Raipur, Chhattisgarh, India.

Raipur
CHHATTISGARH
492099
India 
Phone  8820257946  
Fax    
Email  dr.deepakbiswal1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Kumar Biswal 
Designation  Assistant Professor, Department of Urology 
Affiliation  All India Institute of Medical Sciences, Raipur (C.G.), India. 
Address  Department of Urology, AIIMS Raipur, Chhattisgarh, India.

Raipur
CHHATTISGARH
492099
India 
Phone  8820257946  
Fax    
Email  dr.deepakbiswal1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Kumar Biswal 
Designation  Assistant Professor, Department of Urology 
Affiliation  All India Institute of Medical Sciences, Raipur (C.G.), India. 
Address  Department of Urology, AIIMS Raipur, Chhattisgarh, India.

Raipur
CHHATTISGARH
492099
India 
Phone  8820257946  
Fax    
Email  dr.deepakbiswal1@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur (C.G.), India. 
 
Primary Sponsor  
Name  Dr Deepak Kumar Biswal 
Address  Department of Urology, D-Block, Ground Floor, AIIMS Raipur (C.G.), India. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Kumar Biswal  AIIMS Raipur (C.G.), India.  Department of Urology, D-Block, Ground Floor, AIIMS Raipur, Tatibandh, Chhattisgarh, India- 492099.
Raipur
CHHATTISGARH 		 8820257946

dr.deepakbiswal1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N35||Urethral stricture, (3) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Substitution urethroplasty using everted great saphenous vein graft (eGSV)  Graft for urethroplasty surgery will be taken from either left or right thigh. 
Comparator Agent  Substitution urethroplasty using lingual mucosal graft (LMG)  Graft for urethroplasty surgery will be taken from lower side of the tongue. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  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. 
 
ExclusionCriteria 
Details  1. Previous history of urethroplasty.
2. History of deep vein thrombosis or venous insufficiency in lower limbs.
3. Near-obliterative strictures (urethral caliber <8 Fr).
4. Presence of two separate strictures requiring separate grafts.
5. Body Mass Index (BMI) ≥30.
6. Patients who refuse/ withdraw from the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.  		 Day-1
Day-3
Day-5
1-Month
3-Month
6-Month
1-Year 
 
Secondary Outcome  
Outcome  TimePoints 
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.  1-Month
3-Month
6-Month
1-Year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Buccal mucosal graft is currently the graft of choice for all substitution urethroplasties for urethral stricture disease. It is now considered the gold standard graft. Oral submucosal fibrosis is very common in India due to the use of tobacco products, areca nut and nutritional deficiency. Chronic tobacco and areca nut exposed buccal mucosa make it unsuitable for use in urethral reconstruction surgeries due to reported higher failure rate and donor site morbidity. Lingual mucosal graft now has been used more frequently in Asian countries than the western countries due to the limited availability of buccal mucosa from severe oral submucosal fibrosis associated with prolonged oral tobacco and areca nut use. Although early clinical data show use of lingual mucosa in urethral reconstruction achieves equal success to buccal mucosa, larger studies with longer follow-up are needed to confirm these findings. Lingual mucosal graft harvest-site morbidity should also be considered when treating long strictures, as there is no established safe graft length and larger grafts may cause long-term speech and eating disabilities. In the quest for suitable alternate grafts for urethral substitution in tobacco-exposed oral mucosa; the use of saphenous vein graft has been revived after a few favorable reports of usage in hypospadias surgery.  Initial success was demonstrated in rabbit experimental models. Recently the success of substitution urethroplasty using saphenous vein graft in humans is comparable to buccal mucosal graft found in a study conducted in India. In this study, we will explore the feasibility of substitution urethroplasty using great saphenous vein graft in male patients of anterior urethral strictures along with oral submucous fibrosis. 
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