| CTRI Number |
CTRI/2025/05/086286 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study to compare two techniques of ureteric reimplantation in renal transplantation- Taguchi U-stitch compared to Modified Lich-Gregoire |
|
Scientific Title of Study
|
Comparison of the outcomes of taguchi U-stitch technique and lich-gregoire technique of ureteroneocystostomy- A comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Chauhan |
| Designation |
Senior resident |
| Affiliation |
Postgraduate institute of medical education and research, Chandigarh |
| Address |
Department of renal transplant surgery, Postgraduate institute of medical education and research, Chandigarh, India
Room No. 404, E Block, Married doctors hostel, Postgraduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9015433080 |
| Fax |
|
| Email |
sanlocal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepesh B Kenwar |
| Designation |
Professor |
| Affiliation |
postgraduate institute of medical education and research, Chandigarh |
| Address |
Department Of Renal transplant surgery, postgraduate institute of medical education and research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417434184 |
| Fax |
|
| Email |
deepesh.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Chauhan |
| Designation |
Senior resident |
| Affiliation |
postgraduate institute of medical education and research, Chandigarh |
| Address |
postgraduate institute of medical education and research, Chandigarh, India
room no 404, E block
married doctors hostel,postgraduate institute of medical education and research, Chandigarh, India
pgimer
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9015433080 |
| Fax |
|
| Email |
sanlocal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
postgraduate institute of medical education and research Chandigarh India |
| Address |
Department Of Renal Transplant Surgery, postgraduate institute of medical education and research, Chandigarh, India |
| 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 |
| Sanjeev Chauhan |
Postgraduate Institute Of medical education and research chandigarh, India |
Department Of Renal Transplant Surgery, Postgraduate Institute Of medical education and research chandigarh
Chandigarh
CHANDIGARH |
09015433080
sanlocal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified Lich-gregoire |
Modified Lich-gregoire trchnique of ureteroneocystostomy will be done in second arm of the comparative study |
| Intervention |
Taguchi U-Stitch |
Taguchi U-stitch technique of ureteroneocystostomy will be done in one arm of the comparative study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the patients with chronic kidney disease and end-stage renal disease on maintenance hemodialysis undergoing renal transplant |
|
| ExclusionCriteria |
| Details |
1-patients undergoing second transplant
2-patients undergoing simultaneous pancreas and
kidney transplant
3-patients having double ureter
4-patients with neurogenic or augmented urinary
bladder
5-patients with low bladder capacity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative urological complications(hematuria, urinary leak, UTI, ureteral obstruction) in a time dependant manner serially at admission, 3 months and 6 months after renal transplantation in patients undergoing Taguchi U-stitch and Lich-Gregoir ureteroneocystostomy |
AT 36 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To compare the time taken to complete ureteroneocystostomy by Taguchi U-stitch vs Lich-Gregoir techniques |
AT 24 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This comparative study is a open label, prospective cohort study comparing Taguchi U-stitch technique of ureteroneocystostomy with Modified Lich-Gregoire. Total number of 80 consecutive consented patients of chronic kidney disease with end-stage renal disease on maintenance hemodialysis, under going renal transplant will be included in this study. 40 patients will be enrolled in each cohort using computer based randomisation. Primary objectives studied will be hematuria, urinary leak, ureteral obstruction, urinary tract infections in time dependent manner up to 6 months postoperatively. Secondary objective is to compare time taken to complete Taguchi U-stitch technique of ureteroneocystostomy with Modified Lich-Gregoire. |