| CTRI Number |
CTRI/2023/11/060121 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
23/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Enhanced recovery after surgery protocol when applied on patients undergoing Total Laparoscopic hysterectomy |
|
Scientific Title of Study
|
Impact of Enhanced Recovery After Surgery (ERAS) Protocol Implementation on Post Operative Outcome In Patients Undergoing Total Laparoscopic Hysterectomy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Indu Chawla |
| Designation |
Professor |
| Affiliation |
Dr. RML Hospital, New Delhi |
| Address |
Department of Obstetrics & Gynaecology
Gynae Office
Maternity Nursing Home
Dr. RML Hospital
Baba Kharak Singh Road
Type 3 President Estate
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9871221580 |
| Fax |
|
| Email |
induchawla2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Indu Chawla |
| Designation |
Professor |
| Affiliation |
Dr. RML Hospital New Delhi |
| Address |
Department of Obstetrics & Gynaecology
Gynae Office
Maternity Nursing Home
Dr. RML Hospital
Baba Kharak Singh Road
Type 3 President Estate
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9871221580 |
| Fax |
|
| Email |
induchawla2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nikita Sharma |
| Designation |
Professor |
| Affiliation |
Dr. RML Hospital New Delhi |
| Address |
508 A
NEW Doctors hostel
ABVIMS and Dr. RML Hospital
Baba Kharak Singh Road
Type 3 President Estate
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8448238206 |
| Fax |
|
| Email |
nikitadrbhardwaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics & Gynaecology
Gynae Office
Maternity Nursing Home
Dr. RML Hospital
Baba Kharak Singh Road
Type 3 President Estate
New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr RML Hospital New Delhi |
| Address |
Dr. RML hospital New delhi |
| Type of Sponsor |
Other [Government 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 |
| Dr Indu Chawla |
Atal Bihari Vajpayee Institute of Medical Sciences And Dr. RML Hospital New delhi |
Department of Obstetrics & Gynaecology
Gynae Office
Maternity Nursing Home
Dr. RML Hospital
Baba Kharak Singh Road
Type 3 President Estate
New Delhi
New Delhi
DELHI |
9871221580
induchawla2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ABVIMS, Dr. RML HOSPITAL, NEW DELHI |
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 |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients undergoing Total Laparoscopic Hysterectomy for benign gynaecological
diseases. |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic diseases like Liver disorders, Kidney disorders. 2. Admission to Intensive Care Unit
3. Patients who develop per op complications. (eg. urinary ,bowel or other injuries) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Length of post-operative stay |
within 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for analgesia
Need for anti-emetic
Start of oral tolerance
Surgical site Infections
Return of bowel function
IV fluid resumption
Adherence to ERAS protocol
Re-admission rates |
1 month |
|
|
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)
|
30/11/2023 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
The present study is a comparative prospective observational study which will be conducted in Department of Obstetrics and Gynaecology, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi .The study will be conducted after approval of Institutional Review board and Ethical committee. All patients undergoing Total Laparoscopic Hysterectomy for benign gynaecological diseases will be recruited. Those meeting inclusion and exclusion criteria will be explained the purpose of study in detail and written informed consent will be taken. Detailed history taking and examination of the patient will be done as per the attached study proforma by the examining doctor. The study group will be the one in which the Enhanced Recovery After Surgery (ERAS) principles will be applied |