Kidney stone laser treatment via miniaturised telescopes through the back versus telescopes via the urinary tract in an Indian population
| ISRCTN | ISRCTN20935105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20935105 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | UMP001 |
| Sponsor | Samved Hospital |
| Funder | Samved Hospital |
- Submission date
- 12/04/2020
- Registration date
- 12/05/2020
- Last edited
- 03/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Waste products in the blood can occasionally form crystals that collect inside the kidneys.Over time, the crystals may build up to form a hard stone-like lump. Kidney stones are usually found in the kidneys or in the ureter, the tube that connects the kidneys to your bladder. They can be extremely painful, and can lead to kidney infections or the kidney not working properly if left untreated.
The aim of this study is to compare kidney stone laser treatment via miniaturised telescopes through the back versus telescopes via the urinary tract in an Indian population.
Who can participate?
Patients aged 16 years and above with 10 – 30 mm kidney stone(s).
What does the study involve?
Participants will be randomly allocated to receive ultra-mini percutaneous nephrolithotomy (UMP) or Retrograde Internal Surgery (RIRS) for the removal of kidney stones. Participants will be followed-up at one month.
What are the possible benefits and risks of participating?
The benefits of the mini key hole operation was to avoid the need for a second procedure to remove the stent which is needed for the surgical treatment of the kidney stones via the telescope into the urinary tract from below. The other advantages were the ability to remove the maximum stone burden with a single procedure and which is not uncommon with the operation through the urinary tract from below. This operation is less invasive than the standard operation which involves a bigger size of the telescope. The risks were more or less similar in either of the procedure are blood in the urine and urine infection and which extremely rarely can be serious. The risks of the residual stone following the procedures is another factor to consider in either of them.
Where is the study run from?
Samved Hospital (India)
When is the study starting and how long is it expected to run for?
December 2013 to December 2015
Who is funding the study?
Samved Hospital (India)
Who is the main contact?
Ramandeep Chalokia, rchalokia@yahoo.com
Soumendra Nath Datta, snd999@gmail.com
Dr Janak Desai, drjanak@samvedurology.com
Contact information
Public
5 Duddon Close
Prenton
CH43 2GL
United Kingdom
| Phone | +44 (0)7999344144 |
|---|---|
| rchalokia@yahoo.com |
Public
19 Glen Avenue
Colchester
C03 3SD
United Kingdom
| Phone | +44 (0)7976971601 |
|---|---|
| snd999@gmail.com |
Scientific
Samved Hospital Urology Division
Near Stadium Circle
Navrangpura
Gujarat
Ahmedabad
380009
India
| Phone | +91 7926431616 |
|---|---|
| drjanak@samvedurology.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Ultra mini-percutaneous nephrolithotomy versus retrograde intrarenal surgery in the treatment of 10-30 mm calculi: A randomised controlled trial |
| Study objectives | The aims are to investigate the efficacy, cost and safety of ultra mini-percutaneous nephrolithotomy (UMP) versus retrograde intrarenal surgery (RIRS) in renal calculi between 10 - 30mm |
| Ethics approval(s) | Approved 01/07/2014, Ethics Committee Samved Hospital (2nd Floor Samved Hospital, Near Stadium Circle, Ahmedabad, Gujarat, India, 380009; +91 (0)7926431616; drrushimishra@gmail.com), ref: n/a |
| Health condition(s) or problem(s) studied | Renal calculi |
| Intervention | The patients will be randomised using block randomisation software into either the UMP or RIRS group with a ratio of 2:1. Block randomisation design will be used to reduce bias and achieve balance. Block sizes of 6 will be used. The patients will be informed of the procedure after randomisation. The duration of surgery will be measured (from the visualisation of the stone) and any equipment used during the procedure will be noted to calculate the total cost of the intervention. The requirement and duration of a nephrostomy, DJ stent, and indwelling urinary catheter will be recorded. At the end of each procedure, it will be essential to record the number of patients that will be stone free or had any residual fragments present. Patients will be identified as being stone-free if no identifiable stones can be verified on direct visualization/fluoroscopic. Residual fragments will be defined as those >4 mm. Deterioration in renal function and bleeding will be assessed by comparing pre-operative haemoglobin (Hb) and creatinine levels with those on the first postoperative day. The need and duration of post-operative opioid Intramuscular/Intravenous analgesia will be recorded, and patients with prolonged pain will be identified. Prolonged pain will be defined as greater than two days in duration requiring anti-spasmodic medication. Post-operative complications will be recognised and classified as per the Clavien-Dindo grading system. The length of hospital stay for each patient and the number of patients that will be required to return (e.g. stent removal) will be recorded. Following discharge, patients will be invited back in one month for a follow-up low dose NCCT scan to identify the presence of residual fragments. Residual fragments will be defined as any calcification ≥ 4 mm present on the NCCT in the kidneys, ureters or bladder. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Presence of residual fragments at one month after surgery measured using fluoroscopy |
| Key secondary outcome measure(s) |
1. Duration of surgery (minutes) measured using a clock |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 144 |
| Key inclusion criteria | 1. Age > 16 years 2. 10 - 30mm renal calculi of any position with no history of bleeding diathesis |
| Key exclusion criteria | 1. Abnormal renal or musculoskeletal anatomy 2. Receiving anticoagulants 3. High anaesthetic risk |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- India
Study participating centre
Navrangpura
Ahmedabad
380009
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available upon request from Dr Janak Desai drjanakddesai@gmail.com The data will be available after peer review publication for meta-analysis. Data will be anonymized. There was no specific patient consent for disclosure of data for metanalysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/02/2022 | 03/02/2022 | Yes | No |
Editorial Notes
03/02/2022: Publication reference added.
12/05/2020: Trial’s existence confirmed by Ethics Committee Samved Hospital
