1. Title of the project : A Randomized, Prospective Study to compare the Efficacy
and Safety of Complete Intraureteral Stent Placement versus Conventional Stent
Placement in Relieving Ureteral Stent Related Symptoms
2. Type of Study : Randomized, Prospective, single center study
3. Aims & objectives: -To compare the Efficacy and
Safety of Complete Intraureteral Stent Placement versus Conventional Stent
Placement in Relieving Ureteral Stent Related Symptoms
-To study the post
stenting ureteral symptom score in patients having undergone complete
Intraureteral Stent Placement and Conventional Stent Placement
4. Justification for study:
- More than 80% of urologists
routinely
place ureteral stents after
Ureteroscopy
for urolithiasis to
reduce
postoperative complications.
-Stent related discomfort,
including pain or urinary
symptoms, is considered to be caused by ureteral spasm or trigonal
irritation
due to the presence of stents.
-Agents such as
antimuscarinic drugs or alpha-1 blockers are used to improve these symptoms.
However, these drugs are
associated with side
effects and they cannot be easily administered in patients with comorbidities.
-
The concept of reducing the stent related symptoms using
novel stents and without using drugs seems convincing. However, well-designed
studies are missing and no conclusion can be drawn in terms of potentially lower morbidity.
-Therefore, need of this study is to
know whether complete intraureteral stent, in which the distal end of the ureteral
stent is placed proximal to
the ureteral orifice, would more effectively relieve stent related
discomfort than conventional stent placement, in which the distal end of
the
ureteral stent is placed at
the bladder.
5. Departments involved : Department Of Urology and
Renal Transplant
6. Study period : September 2019 to October 2019
7. Sample size : 100 cases
8. Materials and methods :
Inclusion criteria
Adult patients 18 years old or older who need
unilateral ureteroscopy for urolithiasis with planned ureteral stent insertion
(stone breaking/removal by inserting scope in the ureter and inserting a pipe
from kidney to the bladder) are eligible for study.
Exclusion criteria
Patients having 1) distal ureteral
stones (stones below the sacroiliac joint on NCCT KUB)
2) preoperative ureteral stenting (
inserting stent before procedure)
3) pregnancy or breast feeding
4) bilateral URS surgery (ureteroscopy
on both sides)
5) a solitary kidney ( only one kidney)
6) a potential requirement for a ureteral
stent more than 14 days postoperatively ( required to keep stent for more than
14 days)
7) difficulty in obtaining consent or
other issues such as rating the degree of pain
b)
Biological materials required (type - blood, tissue etc and quantity) : Nil
Detailed
description of procedure / processes :
-The present study shall be conducted on 100
cases diagnosed with ureteric calculus getting admitted to Kasturba Medical
College, Manipal
-Patients shall be selected for study
according to the inclusion and exclusion criteria
-The purpose of the study will be explained to
the patient and informed consent will be obtained for collection of data in
patient’s own vernacular language.
-Patients will be randomized into 2 groups by
using computer generated randomization, as per group 1 and 2.
-As per the standard of care a detailed
history, clinical, laboratory and imaging data of these patients at admission
and then on daily basis will be recorded as per proforma
-Group 1 will undergo standard conventional stent
placement under cystoscopic or fluoroscopic guidance after ureteroscopy is
performed for urolithiasis and group 2
will undergo placement of complete intra ureteral stents with extraction
strings at the end which will also be under cystoscopic or fluoroscopic
guidance.
-
Ureteroscpoy for stone disease shall be performed with rigid/semi-rigid
ureteroscope of size 6/7.5 Fr or 8/9.8 Fr for patients of both the groups.
-
After URS a conventional ureteral stent without string (a 5Fr, 18 cm/6Fr, 20
cm/6Fr, 22 cm/6Fr or 24 cm/6fr or 26cm/6Fr BLUENEEM STENTS) or complete
intraureteral stents with string shall be inserted under cystoscopic or
fluoroscopic guidance according to actual ureteral length in group 1 and group
2 respectively.The accuracy of the correct stent location will be confirmed by
cystoscopy and fluoroscopy at surgery.
-
Both group patients shall be provided these stents free of cost.
Finally
the stent string will be cut approximately 10 cm from the tip of the urethra.
-Intraoperative
data shall be collected as per proforma.
-On
post-operative day 2 patient shall be asked to fill the Ureteral stent symptom
score questionnaire ( English/ Kannada)
-
Patient shall be asked to follow up after 2 weeks on post op day 14 for stent
removal where he/she shall be asked to fill the questionnaire again before
extraction of the stent.
-
Patient shall also undergo X-ray KUB before stent removal to know the position
of stent as per standard routine protocol.
- Based on the Questionnaire filled by patients we shall assess the
safety and efficacy of the complete intra ureteral stent in terms of stent
related symptoms in comparison to conventional stent .
10. Outcome measures : Comparing the efficacy of conventional stent and
complete intraureteral stent in lowering stent related symptoms .
11. Potential risks and benefits:
Risks: The risks associated with using
conventional stents may be pain, increased frequency of micturition,
incontinence, retention of urine, dysuria, fever, hematuria, urinary tract
infection which may be more than those associated with complete intraureteral
stenting. Both the groups carry the same risk however the intra ureteral
stents have shown to have lesser risk.
- In patients with complete
intraureteral stent placement, there will be a string hanging out of the urethra
which can be used to pull the stent out at the time of stent removal. The may
be associated risk of accidental pull out of stent or migration of stent
associated with this group.
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