| CTRI Number |
CTRI/2024/04/065779 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study between Total Laparoscopic Hysterectomy vs. Robotic-assisted Laparoscopic Hysterectomy on Hemodynamics and Ventilatory Mechanics |
|
Scientific Title of Study
|
A Comparative study to assess effects of Pneumoperitoneum and Tredelenburg position on hemodynamics and ventilatory mechanics during Total Laparoscopic Hysterectomy vs. Robotic Assisted 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 SANDEEP KHURANA |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
max superspeciality hospital mohali |
| Address |
MAX SUPERSPECIALITY HOSPITAL
ROOM NO F07
DEPARTMENT OF ANAESTHESIA MOHALI PHASE 6 SECTOR 56
Chandigarh
CHANDIGARH
160059
India |
| Phone |
9888133150 |
| Fax |
|
| Email |
Khurana.anes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Lamiya Haris |
| Designation |
DNB RESIDENT |
| Affiliation |
max superspeciality hospital |
| Address |
MAX SUPER SPECIALITY HOSPITAL
ROOM NO F07
DEPARTMENT OF ANAESTHESIA
MOHALI
Chandigarh
CHANDIGARH
160059
India |
| Phone |
7012630928 |
| Fax |
|
| Email |
lamiyaharis111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR LAMIYA |
| Designation |
DNB RESIDENT |
| Affiliation |
max superspeciality hospital |
| Address |
MAX SUPERSPECIALITY HOSPITAL
FO7 ROOM NUMBER
DEPARTMENT OF ANAESTHESIA
MOHALI
Chandigarh
CHANDIGARH
160059
India |
| Phone |
7012630928 |
| Fax |
|
| Email |
lamiyaharis111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital ,Mohali Punjab |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital Mohali |
| Address |
Max Super Speciality Hospital ,Sector 56,Phase 6
Mohali
MOHALI,PUNJAB
CHANDIGARH
160056 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Lamiya Haris |
Max Superspeciality,Hospital,Mohali |
Max Super speciality Hospital
Phase 4 Sector 56
Mohali
PUNJAB 160056
Chandigarh
CHANDIGARH |
7012630928
lamiyaharis111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients undergoing TLH and RALH
2.ASA grade I,II,III
3.Patients giving consent for the study
4.Patients more than 18 years for age |
|
| ExclusionCriteria |
| Details |
1. Patients refused to give consent for the study.
2.Conversion of laproscopic to open surgeries
3.Patients with pre-existing lung condition.
4.ASA physical status classification greater than IV |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative Study To assess effects of Pneumoperitoneum and Tredenlenburg Position on Hemodynamics and Ventilatory mechanics during Total Laparoscopic Hysterectomy VS Robotic Assissted Laparoscopic Hysterectomy |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess the Cardiovascular & Pulmonary complications due to steep Tredelenburg position & Pneumoperitoneum during Robotic Assisted Hysterectomy |
5 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THIS STUDY IS A PROSPECTIVE,NON RANDOMISED ,OPEN LABEL,OBSERVATIONAL STUDY THAT WILL BE ORGANISED AND CARRIED OUT IN THE DEPARTMENT OF ANAESTHESIOLOGY,MAX SUPERSPECIALITY HOSPITAL,MOHALI ,PUNJAB WITH DUE CONSENT FROM THE INSTITUTIONAL ETHICS COMMITTEE AND REVIEW BOARD AND IN COMPLIANCE TO INFORMED ,WRITTEN CONSENTS TAKEN FROM THE PATIENTS.THIS STUDY IS TO ASSESS THE EFFECTS OF PNEUMOPERITONEUM AND TREDELENBURG POSITION ON HEMODYNAMICS AND VENTILATORY MECHANICS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY VS ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY |