| CTRI Number |
CTRI/2021/02/031454 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
09/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of early versus routine removal of urinary catheter after laparoscopic hysterectomy |
|
Scientific Title of Study
|
A randomised controlled trial of early versus routine removal of self retaining urinary catheter after uncomplicated total laproscopic hysterectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Anant |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
2C , AIIMS Patna OPD Building, AIIMS-Patna, Phulwarisharif, near WALMI
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drmonika.anant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Anant |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
2C , AIIMS Patna OPD Building, AIIMS-Patna, Phulwarisharif, near WALMI
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drmonika.anant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Anant |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
2C , AIIMS Patna OPD Building, AIIMS-Patna, Phulwarisharif, near WALMI
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drmonika.anant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
AIIMS Patna
Phulwarisharif
Patna 701507 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sonam |
All India Institute of Medical Sciences - Patna |
Room 242, second floor, OPD Building, Obstetrics & Gynaecology department, AIIMS Patna Phulwarisharif, Near WALMI, Patna 801507
Patna
BIHAR |
7764946249
sonamyadav5109210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Patna |
Approved |
| Institutional Ethics Committee AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1) Removal of urinary catheter post laparoscopic hysterectomy 6hours |
Patients who will undergo Total laparoscopic hysterectomy (TLH), informed consent will be taken. Further randomization will be done and patients will be divided into two groups on the basis of time of Foleys removal i.e. early catheter removal (ECR) means catheter removal within 4hrs and Routine catheter removal (RCR) means catheter removal within 18-24hrs. Further we will notice that, if patient has voided urine within 6hrs of catheter removal. If the patient voided the urine within 6hrs of catheter removal then using Ultrasonography (USG) we will measure the postvoidal residual urine volume (PVRU) to see whether the voiding is partial or complete. If the PVRU is less than 100ml than it means that voiding is complete and patient is fit for discharge and if PVRU is between 100-500ml than there is only partial voiding and we have to further wait for 3hrs- following USG we will measure PRVU again and if there is complete voiding of urine we will discharge the patient after urine routine examination and culture sensitivity. If there is partial voiding of urine we will recatheterize the patient.
If patient has not voided urine within 6hrs of catheter removal then using Ultrasonography bladder scan will done and PVRU will be measured. If the PVRU volume is more than 500ml than we will recatheterize the patient for 24hrs. Also before discharging patients we will do a routine urine examination and culture sensitivity test.
|
| Comparator Agent |
Removal of urinary catheter post laparoscopic hysterectomy 24 hours |
Patients who will undergo Total laparoscopic hysterectomy (TLH), informed consent will be taken. Further randomization will be done and patients will be divided into two groups on the basis of time of Foleys removal i.e. early catheter removal (ECR) means catheter removal within 4hrs and Routine catheter removal (RCR) means catheter removal within 18-24hrs. Further we will notice that, if patient has voided urine within 6hrs of catheter removal. If the patient voided the urine within 6hrs of catheter removal then using Ultrasonography (USG) we will measure the postvoidal residual urine volume (PVRU) to see whether the voiding is partial or complete. If the PVRU is less than 100ml than it means that voiding is complete and patient is fit for discharge and if PVRU is between 100-500ml than there is only partial voiding and we have to further wait for 3hrs- following USG we will measure PRVU again and if there is complete voiding of urine we will discharge the patient after urine routine examination and culture sensitivity. If there is partial voiding of urine we will recatheterize the patient. If patient has not voided urine within 6hrs of catheter removal then using Ultrasonography bladder scan will done and PVRU will be measured. If the PVRU volume is more than 500ml than we will recatheterize the patient for 24hrs. Also before discharging patients we will do a routine urine examination and culture sensitivity test |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1) All patients posted for TLH for the benign indication (e.g. AUB, Fibroids) and low-grade malignancy.
2) Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Patients not willing to participate in the study
2) Pregnant women
3) TLH patients having concomitant procedures such as prolapse surgery
3) TLH patients with extensive adhesions like endometriosis surgery or advanced oncological dissection including nodal dissection
4) Those with stress and urge incontinence
5) Patients with pre-op UTI
6) Inability to void (paraplegia, MS)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Voiding difficulty after ECR (time frame : 6 hours after removal of catheter) in uncomplicated TLH patients |
6 hours after removal of catheter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. PVR ( post void residual urine)
b. Rate of recatheterisation
c. Incidence of UTI in post operative period in TLH.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/02/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
During
Total laparoscopic hysterectomy (TLH), standard care is to place an indwelling catheter,
usually self-retaining, during surgery to avoid iatrogenic injuries of the bladder, monitor urinary output and check for hematuria.
Time
of removal of this catheter in uncomplicated cases is usually after 24 hours.
There is limited guidelines for catheter removal post-TLH.
According
to Cochrane review (2008), catheter placement should only be as long as
required, as prolonged catheterization is associated with urinary tract
infections, delayed mobilization of patients and longer time to discharge
increasing unnecessary hospital stay. Patients too have discomfort while on
catheter.
If
ECR outcomes are found to be similar or better than RCR, patients maybe
discharged earlier reducing hospital stay and well-being.
Problem
Statement/ Rationale: early removal of the catheter
may overcome all these issues but also have been associated with higher urinary
retention rates and re-catheterization. However, many centers have now started
daycare hysterectomy requiring immediate or early removal of catheter but
evidence for this is limited.
Novelty: With
this in mind, we intend to evaluate if early catheter removal (ECR- <4 hours)
after TLH was associated with similar or better outcomes compared with routine
catheter removal (RCR- >24hrs) through this study,
it proves its Originality.
Research Question: To see voiding difficulty after early vs delayed
removal of urinary catheters.
Research Hypothesis: The study is based on the assumption that ECR has similar/better outcomes than RCR |