| 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
|
|
|
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
|
|
|
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. |