| CTRI Number |
CTRI/2024/08/072250 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To see if there is a difference in the recovery of gut function in the patient undergoing removal of left vs right kidney |
|
Scientific Title of Study
|
Prospective Observational study comparing the impact of laterality on recovery of bowel function Following Left VS Right Nephrectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarnendu Mandal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Dept of Urology , 2nd Floor , AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India
Kendrapara
ORISSA
751019
India |
| Phone |
8447562972 |
| Fax |
|
| Email |
urol_swarnendu@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Saharsh Ambade |
| Designation |
senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Department of Urology, 2nd Floor. AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India
Kendrapara
ORISSA
751019
India |
| Phone |
8586097324 |
| Fax |
|
| Email |
ambade3582@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saharsh Ambade |
| Designation |
senior resident |
| Affiliation |
All India Institute Of Medical Science, Bhubaneswar |
| Address |
Department of Urology, 2nd Floor. AIIMS Bhubaneswar
Kendrapara
ORISSA
751019
India
Kendrapara
ORISSA
751019
India |
| Phone |
8586097324 |
| Fax |
|
| Email |
ambade3582@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Urology , 2nd Floor , AIIMS Bhubaneswar, Kendrapara
ORISSA, pin code : 751019
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences Bhubaneswar |
| Address |
Dept of Urology , 2nd Floor , AIIMS Bhubaneswar
751019
Kendrapara
ORISSA
751019
India |
| 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 Saharsh Ambade |
All India Institute Of Medical Sciences , Bhubaneswar |
Department of urology, 2nd floor , Room no 245 , AIIMS, Bhubaneswar , Odisha
Kendrapara
ORISSA
Kendrapara
ORISSA |
8586097324
ambade3582@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Partial / Radical / Simple / Donor nephrectomy
Written informed consent |
|
| ExclusionCriteria |
| Details |
ASA Grade ≥ 3 (Patients Unfit for Surgery)
Laparoscopic to Open conversion
Patient undergoing cytoreductive nephrectomy
Major intraoperative complications like bowel injury, vascular injury |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the difference between return of bowel function in patients undergoing left vs right
nephrectomy |
Post op day 0
Post op day 1
Post op day 2
Post op day 3 and further till pt. bowel function is recovered |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
20/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative bowel dysfunction is a common complication seen in the patients
undergoing abdominal surgery that involves bowel manipulation. However there is limited
literature addressing post operative bowel function recovery following Nephrectomy
and no Literature is available which compares left vs right nephrectomy in terms of
post operative bowel dysfunction. Understanding such differences will allow Better
counselling of patient in terms of post operative recovery, Intraoperative and post
operative adoption of measures to decrease the morbidity associated with post
operative bowel dysfunction, Early adoption of therapeutic measures for expected
delayed return of bowel function. The purpose of This study is to identify such
differences in post operative bowel recovery in patients undergoing left vs right
nephrectomy. |