| CTRI Number |
CTRI/2022/01/039199 [Registered on: 06/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [post operative care changes] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the safety and practicability of mono polar urethral route removal of prostate without post-surgery urinary catheter traction in patients with enlarged prostate |
|
Scientific Title of Study
|
A randomized control trial to evaluate the safety and feasibility of mono polar transurethral resection of prostate without post-operative urethral catheter traction in benign prostatic hyperplasia patients in a teritary care institute |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhineeth K P |
| Designation |
senior resident(academic) |
| Affiliation |
All India Institute of Medical sciences ,bhopal |
| Address |
Department of urology,All India Institute of Medical Sciences Bhopal,saket nagar,bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9560252097 |
| Fax |
|
| Email |
abhineethkp.pg2021@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Biswas |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical sciences ,bhopal |
| Address |
Department of urology,All India Institute of Medical Sciences Bhopal,saket nagar,bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9675480523 |
| Fax |
|
| Email |
manoj.urology@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhineeth K P |
| Designation |
senior resident(academic) |
| Affiliation |
All India Institute of Medical sciences ,bhopal |
| Address |
Department of urology,All India Institute of Medical Sciences Bhopal,saket nagar,bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9560252097 |
| Fax |
|
| Email |
abhineethkp.pg2021@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhopal |
|
|
Primary Sponsor
|
| Name |
Abhineeth K P |
| Address |
Department Of urology,AIIMS Bhopal, saket nagar, MP |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Abhineeth K P |
AIIMS Bhopal |
Urology ward,3rd floor, department of urology
Bhopal
MADHYA PRADESH |
9560252097
abhineethkp.pg2021@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- PostGraduate Research(IHEC-PGR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In the Control group, urethral catheter traction will be given post operatively |
In the Control group, urethral catheter traction will be given with the help of sticking plaster to the medial side of one of the thighs. The amount of traction will be considered sufficient when the Y of the catheter reaches the knee joint. Patients are informed not to move the limb at the hip and knee joint to which the catheter is applied. The traction is removed on the morning of post-operative day one. In study groups patient traction is not applied, and they can move in the bed. Continuous irrigation with saline is given to both patients. Irrigation is stopped if urine is clear from the next morning of the procedure .
Urethral Catheter will be removed when irrigation fluid colour is clear after post-operative day one. Patients will be discharged if they can urinate without the catheter. Successful voiding without catheter is defined as patient voiding within 6 hours of Catheter removal with a voided volume 100 ml and post void residual volume 200 ml
|
| Intervention |
not applying traction in post operative patients of transurethral resection of prostate |
All the patients in the no traction group will be carefully observed for gross hematuria. If any patient has gross hematuria, traction with urethral catheter will be applied. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
prostate size of 30-80 ml |
|
| ExclusionCriteria |
| Details |
1) Patients refusing to participate/give consent.
2) Patients failed to achieve Intraoperative
hemostasis.
3) Patients with both BPH and bladder tumor
4) Patients with both BPH and bladder stone
5) Patients with both BPH and Urethral stricture
disease
6) Patients with both BPH and meatal stenosis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To compare pain scores
2) to compare the post operative blood loss |
1) pain scores - using visual analogue score will be recorded at 6 hour,12 hour and 18 hour post surgery
2) Blood loss will be calculated using Bourke’s formula , preopertaive hematocrit and postoperative hematocrit will be evaluated at post operative day one. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the duration of hospital stay.
2.To compare the incidence of bladder washouts and clot retention.
3.To compare the incidence of deep venous thrombosis
|
1)Duration of hospital stay. (Calculated from the day of surgery to day of discharge)
2)The incidence of bladder washouts and clot retention
3)The incidence of deep vein thrombosis
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhineethkp.pg2021@aiimsbhopal.edu.in].
- For how long will this data be available start date provided 01-01-2022 and end date provided 01-08-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This
study is a randomized, double blind, parallel group, clinical trial to evaluate
the safety and feasibility of Monopolar Transurethral resection of prostate
without postoperative urinary catheter traction. The gold standard
surgical management of Benign prostatic hyperplasia is transurethral resection
of prostate. An electrified wire loop is used to remove the part of
the prostate between the bladder neck and the verumontanum up to the
depth of the surgical capsule. Incomplete hemostasis during the operation makes
post-surgical bleeding one of the major drawbacks of transurethral resection of
prostate.Traction with a urethral catheter can decrease bleeding after transurethral resection of
prostate. There is no standard protocol for the post operative management of
patients with intraoperatively achieved hemostasis. Patients can be either
given traction with a urethral catheter or can avoid traction. With careful
coagulation of venous and arterial bleeding, hemostasis can be achieved, thus
avoiding the need for traction after the surgery. Also, traction results in
increased pain and analgesic consumption in patients. In this study, we will evaluate the need for
traction if hemostasis can be secured intraoperatively, which will help to
decrease the morbidity associated with traction. This will be achieved by
comparing the pain score and post operative blood loss of patients with urethral
catheter traction and without urethral catheter traction.
|