| CTRI Number |
CTRI/2018/11/016299 [Registered on: 09/11/2018] Trial Registered Prospectively |
| Last Modified On: |
06/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of early versus late removal of urinary catheter after surgery for cervical cancer |
|
Scientific Title of Study
|
A randomized controlled trial comparing early versus late catheter removal after radical hysterectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amy Jose |
| Designation |
Post doctoral fellow |
| Affiliation |
Christian medical college , Vellore |
| Address |
Department of Gynaecologic Oncology
Vellore
TAMIL NADU
632004
India |
| Phone |
9445586032 |
| Fax |
|
| Email |
amy.jose@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Abraham Peedicayil |
| Designation |
Professor and Head |
| Affiliation |
Christian medical college , Vellore |
| Address |
Department of Gynaecologic Oncology
Christian Medical College ,Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
|
| Fax |
|
| Email |
abraham@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Amy Jose |
| Designation |
Post doctoral fellow |
| Affiliation |
Christian medical college , Vellore |
| Address |
Department of Gynaecologic Oncology
Vellore
TAMIL NADU
632004
India |
| Phone |
9445586032 |
| Fax |
|
| Email |
amy.jose@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Fluid research grant ,Christian medical college ,Vellore |
|
|
Primary Sponsor
|
| Name |
FLUID RESEARCH GRANT |
| Address |
CHRISTIAN MEDICAL COLLEGE,
VELLORE |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Amy Jose |
Christian medical college |
Department of Gynaecologic Oncology
Christian medical college
Vellore
TAMIL NADU |
9445586032
amy.jose@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (Silver,Research and Ethics Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Effect of early catheter removal in those undergoing radical hysterectomy in early stage cervical cancer compared to the late removal group., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
early catheter removal group |
Will be assigned for catheter removal on post operative day 4+/-1 day |
| Comparator Agent |
late catheter removal group |
Will be assigned for catheter removal on post operative day 10+/- day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All early stages (IA2, IB1,IIA1) cervical cancer undergoing radical hysterectomy |
|
| ExclusionCriteria |
| Details |
Non cervical cancer
Previous pelvic irradiation
Prior urinary dysfunction
Bladder injury during surgery
Other indications for prolonging bladder catheterisation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urinary infection rate |
after adequate sample collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Urinary retention rate (Recatheterisation rate)
Bladder dysfunction rate (CIC rate)
|
final analyses |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/11/2018 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Radical hysterectomy is the primary mode of therapy for early stage cervical cancer.Urinary tract complications are common following radical hysterectomy.These include prolonged bladder dysfunction resulting in urinary retention ,diminished bladder sensation ,urinary infection and fistula formation.The etiology of these comlicaions is thought to be due to the extensive dissection during the procedure leading to sensory or motor abnormalities of the detrusor muscle or a combination of both which can be exacerbated by the local haematoma, edema, and fibrosis.However the pathophysiology of bladder dysfunctiion remains poorly understood.Decreased bladder sensation and urinary retention are observed in some women requiring prolonged bladder catheterisation, intermittent self catheterisation, or supra pubic pressure to empty the bladder completely.Prolonged bladder catheterisation is a cornerstone of post operative managementafter radical hysterectomy with a view to prvent these bladder complications. The incidence of bladder dysfunction after radical hysterectomy varies from 12% to 85% depending on the method used in the evaluation of bladder dysfunction, duration of follow up. In addition the rate of bladder dysfunction depends on the radicality of surgery.Nerve sparing readical hysterectomy that is currently being practised should reduce the bladder dysfunction.Currently controversy exists with regard to theduration of bladder drainage and choice of catheter used in bladder drainage. Although survival outcomes of women with early stage cervical cancer after radical hysterectomy are excellent, surgery was frequently associated with post operative complications particularly bladder dysfunction that affects quality of life.Also there is evidence that prolonged bladder catheterisaton may have adverse effeccts such as delayed ambulation and urinary tract infections. all patients undergoing radical hysterctomy at our center will be invited to participate in this study and will have an equal chance of early or late catheter removal.The early group will have catheter removed before discharge on 4th +/- 1 day and in the late group after discharge on 10th+/-1 day.Aftr catheter removal sample of urine will be sent for culture for all patients.If patient has a voiding problem the catheter will be put back.Any woman continuing to have bladder dysfunction will be taught clean intermittent self catheterisation and referred to urologist if problem persists after a month.
|