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CTRI Number  CTRI/2025/08/093167 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 17/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study in patients with bladder cancer comparing traditional surgery and laser surgery for better treatment outcomes 
Scientific Title of Study   A RANDOMISED CONTROLLED TRIAL COMPARING CONVENTIONAL TRANSURETHRAL RESECTION OF BLADDER TUMOUR VERSUS HOLMIUM LASER EN BLOC TRANSURETHRAL RESECTION OF BLADDER TUMOUR 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subeesh P 
Designation  Assistant Professor 
Affiliation  Government Medical College Kozhikode 
Address  Department Of Urology and Renal Transplant, Government Medical College, Kozhikode, Kerala
Department Of Urology and Renal Transplant, Government Medical College, Kozhikode, Kerala
Kozhikode
KERALA
673008
India 
Phone  8547774477  
Fax    
Email  parolsubeesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subeesh P 
Designation  Assistant Professor 
Affiliation  Government Medical College Kozhikode 
Address  Department Of Urology and Renal Transplant, Government Medical College, Kozhikode, Kerala
Department Of Urology and Renal Transplant, Government Medical College, Kozhikode, Kerala
Kozhikode
KERALA
673008
India 
Phone  8547774477  
Fax    
Email  parolsubeesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subeesh P 
Designation  Assistant Professor 
Affiliation  Government Medical College Kozhikode 
Address  Department Of Urology and Renal Transplant, Government Medical College, Kozhikode, Kerala
Department Of Urology and Renal Transplant, Government Medical College, Kozhikode, Kerala
Kozhikode
KERALA
673008
India 
Phone  8547774477  
Fax    
Email  parolsubeesh@gmail.com  
 
Source of Monetary or Material Support  
Department of Urology, Government medical College Kozhikode, Medical College PO, Kozhikode Kerala Pin 673008 
 
Primary Sponsor  
Name  Nil  
Address  Nil 
Type of Sponsor  Government medical college 
 
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 
Subeesh P  Government Medical College Kozhikode, Kerala   Room no G20, Department of Urology Government medical college, Kozhikode, Medical college Kerala 673008
Kozhikode
KERALA 
8547774477

parolsubeesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC GOVERNMENT MEDICAL COLLEGE KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C678||Malignant neoplasm of overlappingsites of bladder, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Holmium En Bloc Resection of bladder Tumor and Transurethral resection of bladder tumour  Detrusor muscle in resected specimen and recurrence free survival is compared 
Intervention  TURBT Group: Standard transurethral resection using electrocautery. HolERBT Group: En-bloc resection using a holmium laser.   Participants will be randomly assigned to either the cTURBT group or the HolERBT group using a computer-generated randomization sequence 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Tumor size less than or equal to 3cm.

Number of tumors less than 3 in number

No prior intravesical therapy.

 
 
ExclusionCriteria 
Details  Muscle-invasive bladder cancer.

Tumors located in areas difficult to access endoscopically.

Ureteral involvement

Metastatic bladder tumour

Patients with coagulopathies or on anticoagulant therapy that cannot be safely discontinued.

Severe comorbidities contraindicating surgery.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Presence of detrusor muscle in the resected specimen, indicating the quality of resection  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence-Free Survival (RFS): Defined as the time from the date of the initial resection to the first documented recurrence of bladder cancer, confirmed by follow-up cystoscopic evaluations.   3months,6months, and 12months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Bladder cancer is the 10th most common cancer worldwide, with non-muscle-invasive bladder cancer (NMIBC) accounting for approximately 75 to 80 percent of cases at diagnosis. The standard treatment for NMIBC is transurethral resection of bladder tumor (TURBT), but this conventional method has several limitations:


Fragmented tumor resection can hinder accurate pathological assessment.

Absence of detrusor muscle in specimens occurs in about 10 to 51 percent of cases, compromising staging accuracy.High recurrence rates, with studies reporting recurrence in a significant proportion of patients within 5 years.Complications such as bleeding, obturator nerve reflex (ONR), and bladder perforation are associated with conventional TURBT.



To address these challenges, Holmium Laser En Bloc Resection of Bladder Tumors (HoLEBT) has been introduced as an alternative technique. HoLEBT offers several potential advantages


En bloc tumor excision allows for intact specimen retrieval, facilitating precise pathological evaluation.Higher rates of detrusor muscle presence in resected specimens, enhancing staging accuracy.Reduced intraoperative complications, including lower incidences of ONR and bladder perforation.Shorter catheterization and hospitalization times, improving patient recovery.Comparable or improved recurrence-free survival rates compared to conventional TURBT.



Despite these promising outcomes, there is a need for more high-quality randomized controlled trials to conclusively determine the efficacy and safety of HoLEBT compared to conventional TURBT. This study aims to fill this gap by evaluating recurrence-free survival, perioperative outcomes, and specimen quality differences between the two techniques.

 
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