| CTRI Number |
CTRI/2014/03/004511 [Registered on: 28/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/01/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a trial to compare pain during Dj stent removal using different techniques- Flexible cystoscope and semirigid ureteroscope |
|
Scientific Title of Study
|
Randomised control trial to compare pain during DoubleJ stent removal using Flexible cystoscope and Semirigid Ureteroscope |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeraj Agrawal |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Urology, JIPMER, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
neeraj_agrus@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Manikandan |
| Designation |
Assistant proffessor |
| Affiliation |
JIPMER |
| Address |
Department of Urology, JIPMER, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
minks_77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Agrawal |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
H NO 23 OLD MSR, JIPMER, Puducherry 605006
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
neeraj_agrus@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
dhanvantri nagar, puducherry |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Neeraj Agrawal |
Department of Urology, 3rd floor, SSB |
JIPMER, dhanvantri nagar, puducherry
Pondicherry
PONDICHERRY |
9488516897
neeraj_agrus@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee(Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All adult patients 18 yrs and above with unilateral DJS in situ for 2 to 6 weeks, due for stent removal, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flexible Cystoscope |
Dj stent will be removed using Flexible cystoscope under local anaesthesia after instillation of 10ml of 2% lignocaine jelly. Time and operative difficulty during procedure will be noted. After the procedure, patient will be asked to score his pain on VAS from 1 to 10. all the parameters will be compared to those of semirigid ureteroscope. |
| Intervention |
Semirigid Ureteroscope |
Dj stent will be removed using Semirigid Ureteroscope under local anaesthesia after instillation of 10ml of 2% lignocaine jelly. Time and operative difficulty during procedure will be noted. After the procedure, patient will be asked to score his pain on VAS from 1 to 10 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients 18 yrs and above with unilateral DJ stent in situ for 2-6 weeks, due for Dj stent removal |
|
| ExclusionCriteria |
| Details |
Migrated stents, Severe comorbidities, encrusted stents, Post renal transplant, Residual or bilateral stent |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score of pain |
during and at the end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| operative time, VAS score of operative difficulty and complications |
during the procedure |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
10/06/2013 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ureteral stent mostly Double J stent (DJ stent) which are placed for various indications like ureterescopic stone removal, PCNL, pyeloplasty, ESWL are an integral part of urological practice. The stents are usually removed after 2 to 6 weeks after the initial therapeutic procedure. Rigid cystoscope which were used for stent removal is associated with discomfort and pain, especially in male patients because of longer urethra. Some studies had compared flexible and rigid cystoscopy in terms of patient discomfort and pain but for cystoscopy only without any adjuvant procedure. Flexible cystoscopy(FC) is associated with high initial and mantanence costs and in a developing nation like ours cost implication are important. Soylemez et al used semirigid ureteroscope(SRU) for cystoscopy and stent removal in both male and female patients and found it comparable to flexible cystoscope with lower cost. Till now no study has compared these different techniques for stent retrieval in male patients and no consensus is there regarding the best technique, so we designed this study as a RCT for comparing flexible cystoscope and semierigid ureteroscope for stent removal in our patients.
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