| CTRI Number |
CTRI/2019/05/019394 [Registered on: 28/05/2019] Trial Registered Prospectively |
| Last Modified On: |
27/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Foleys catheter] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the post operative outcomes of patients who undergo non descent vaginal hysterectomy in whom foleys catheter is placed or not |
|
Scientific Title of Study
|
A Randomised controlled trial comparing post-operative outcomes of patients planned for non descent vaginal hysterectomy with or without indwelling foleys catheter |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Sharma |
| Designation |
Junior resident |
| Affiliation |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Department of obstetrics and gynaecology Dr Rajendra Prasad Govt Medical college kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816805128 |
| Fax |
|
| Email |
shalinisharma1992.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chander Deep Sharma |
| Designation |
Assistant professor |
| Affiliation |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Department of obstetrics and gynaecology Dr Rajendra Prasad Govt Medical college kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816326544 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chander Deep Sharma |
| Designation |
Assistant professor |
| Affiliation |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Department of obstetrics and gynaecology Dr Rajendra Prasad Govt Medical college kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816326544 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology Dr Rajendra Prasad Medical College Kangra at tanda Himachal Pradesh 176001 |
|
|
Primary Sponsor
|
| Name |
Government health schemes |
| Address |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| 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 Shalini Sharma |
Dr Rajendra Prasad Medical College Kangra at Tanda |
Gynae ward department of obstetrics and gynaecology
Kangra
HIMACHAL PRADESH |
9816805128
Shalinisharma1992.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra Prasad Govt Medical College Kangra at Tanda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foleys catheter |
In one group no Foleys catheter will be used after surgery,recatheterization will be done if patient could not void within 6 hrs of surgery or after 2 attempts to void.In second group Foleys catheter will be placed immediately after surgery |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
NDVH for benign gynecological indications
Vaginal hysterectomy with no obvious prolapse or <1 degree prolapse |
|
| ExclusionCriteria |
| Details |
Vaginal hysterectomy for pelvic organ prolapse (POP)
Suspected malignancy
Diagnosis suspicious for endometriosis
Large tubo-ovarian absess
Ovarian cysts
Previous pelvic surgery by abdominal approach
Pelvic inflammatory disease
Extensive vaginal discharge
Local vaginal or cervical infection
Positive pre-operative urine culture
Known history of neurological disorder
Patient with recurrent UTI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Positive urine cultureo( at least 105 colony forming units of an identified single uropathogen per millilitre )
Symptomatic UTI
Re-catheterization
Post-operative pyrexia |
Urine specimen will be obtained on the postoperative day 2 and 2 week after surgery for culture and sensitivity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Catheter associated pain
Duration of hospital stay
Time to first ambulation |
The time to ambulation will be 6-8 hrs
The length of hospital stay will be atleast 2 days |
|
|
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)
|
01/06/2019 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The use of an indwelling catheter for the first 24 hours after routine hysterectomy has been based on custom with no evidence based support. Indwelling urinary catheter associated with a higher incidence of symptomatic urinary tract infections, post operative pyrexia, catheter associated pain,delayed ambulation time and longer hospital stay however more chances of retention of urine in case of no indwelling catheter.So this study is designed for comparing post operative outcomes of patients planned for NDVH with or without indwelling foleys catheter |