Comparative study of two interventional procedures for the treatment of kidney stones in order to ascertain which is the better technique
| ISRCTN | ISRCTN12012144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12012144 |
| Secondary identifying numbers | PGHI-IRB(DMe)-RCD-06-002 |
- Submission date
- 02/02/2022
- Registration date
- 16/02/2022
- Last edited
- 05/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
A kidney stone that blocks the ureter, the tube that connects your kidney to your bladder, can cause a kidney infection. This is because waste products are unable to pass the blockage, which may cause a build-up of bacteria.
An external ureteral catheter (a tube that collects urine from the kidney and passes it to a bag outside the body) and double J stent (a tube placed inside the ureter to hold it open and allow urine past the blockage) are both commonly used techniques to drain upper urinary passages in the treatment of kidney stones. We are comparing the outcomes of these two procedures in patients with kidney stones in order to identify a better technique for the management of kidney stones in terms of post-surgical stent-related symptoms.
Who can participate?
Patients aged 18 - 70 years with kidney stones.
What does the study involve?
Participants will be randomly allocated to receive an external catheter or double J stent.
What are the possible benefits and risks of participating?
Possible benefit would be to choose a better technique with less complications in management of renal stones.
Possible risks include surgery related infections and bleeding .
Where is the study run from?
Pakistan Atomic Energy General Hospital
When is the study starting and how long is it expected to run for?
September 2019 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Bilal Habib, rbilal14@yahoo.com
Contact information
Principal Investigator
Department of urology
Paec general hospital
H 11 /4
Islamabad
44000
Pakistan
 ORCID ID |
0000-0003-3057-0939 |
|---|---|
| Phone | +92 3318126221 |
| rbilal14@yahoo.com |
Scientific
Department of urology
Paec general hospital
H 11 /4
Islamabad
44000
Pakistan
| Phone | +92 3318126221 |
|---|---|
| rbilal14@yahoo.com |
Public
Department of urology PAEC General hospital H 11/4 Islamabad
Islamabad
44000
Pakistan
| Phone | +92 3318126221 |
|---|---|
| rbilal14@yahoo.com |
Study information
| Study design | Single center interventional double blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Which is the better technique in terms of postoperative stent-related complications? A comparative study of externalized ureteral catheter versus double-J stent on percutaneous nephrolithotomy |
| Study objectives | To identify a better technique for the management of renal stones in terms of postoperative stent related symptoms. |
| Ethics approval(s) | Approved 24/09/2019, Institutional Ethical Committee of PGHI (Faqir Aipee road, H 11/4, Islamabad, Pakistan; +92514434521; Pghiethics@outlook.com), ref: PGHI-IRB (DMe)-RCD-06-002 |
| Health condition(s) or problem(s) studied | Externalized ureteral catheter versus double-J stent on percutaneous nephrolithotomy |
| Intervention | Enrolled patients were randomized by using the lottery method of randomization into two groups: Group I (Double J stent placement) Group II (Externalized ureteral catheter) All the enrolled patients underwent the percutaneous nephrolithotomy (PCNL) procedure as per the standard protocol of our setting. In group I , the DJ stent was placed anterogradely under fluoroscopy. In group II, the EUC was left at the end of the procedure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Stent related symptoms measured using interview of patients/history taking at post operative Day 1, day 2 and week 2 |
| Secondary outcome measures | Measured using interview of patients/history taking at post operative Day 1, day 2 and week 2 1. Urinary leak 2. Fever 3. Analgesia requirement 4. Length of hospital stay |
| Overall study start date | 01/09/2019 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Age 18-70 years 2. Cumulative stone diameter <4cm 3. Without ureteral obstruction 4. Single access site |
| Key exclusion criteria | 1. Bleeding disorders 2. Presence of significant residual calculi 3. Pyouria 4. Perforation of the renal collecting system 5. Severe intraoperative or post operative hemorrhage 6. Second look procedure necessity |
| Date of first enrolment | 24/09/2019 |
| Date of final enrolment | 25/08/2020 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Faqir Apee Road H 11/4 Islamabad
Islamabad
44000
Pakistan
Sponsor information
Hospital/treatment centre
H-11/4
Islamabad
-
Pakistan
| Phone | +923335175742 |
|---|---|
| Pghiethics@outlook.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/03/2022 | 05/09/2022 | Yes | No |
Editorial Notes
05/09/2022: Publication reference added.
14/02/2022: Trial's existence confirmed by Institutional Ethical Committee of PGHI.
