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CTRI Number  CTRI/2024/10/075615 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the use of fan retractor and Nathanson retractor for liver retraction in laparoscopic bariatric surgery. 
Scientific Title of Study   A randomised controlled trial to compare the use of fan retractor and Nathanson retractor for operative view score after liver retraction in laparoscopic bariatric surgery. 
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 Amneet Kaur 
Designation  PG Resident 
Affiliation  Lady Hardinge Medical College and Associated Hospitals, New Delhi 
Address  Lady Hardinge Medical College and Associated Hospitals, New Delhi


DELHI
110001
India 
Phone  7986611519  
Fax    
Email  amneetkaur2598@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Arsia 
Designation  Professor 
Affiliation  Lady Hardinge Medical College and Associated Hospitals, New Delhi 
Address  Department of General Surgery Lady Hardinge Medical College and Associated Hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9810283361  
Fax    
Email  ashish.arsia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Arsia 
Designation  Professor 
Affiliation  Lady Hardinge Medical College and Associated Hospitals, New Delhi 
Address  Department of General Surgery Lady Hardinge Medical College and Associated Hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9810283361  
Fax    
Email  ashish.arsia@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and Associated Hospitals, New Delhi, India 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College  
Address  Department of General Surgery, Lady Hardinge Medical College, New Delhi, India 110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amneet Kaur  Lady Hardinge Medical College and Associated Hospitals, New Delhi  Wing 2, 4th Floor, IPD Block, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi 110001
New Delhi
DELHI 
7986611519

amneetkaur2598@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lady Hardinge Medical College and Associated Hospitals, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fan Retractor  Fan retractor is also used to retract the left lobe in order visualize stomach, GE junction and preserve major nerves and vessels. It comes in different sizes like 5mm, 10mm.  
Comparator Agent  Nathanson Retractor  Nathanson retractor is used in upper GI surgeries for steady retraction of left lobe of liver. It does not require use of an assistant for retraction. However, it has been described in literature that it causes measurable liver damage and associated with post-operative pain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing laparoscopic bariatric surgery with BMI less than 50 kg/m2 who consent to participate in the study 
 
ExclusionCriteria 
Details  Patients who have undergone previous upper abdominal surgeries
Patients with severe liver pathology, such as cirrhosis, hepatitis or extensive tumors
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Operative view score   Intra-operatively after placement of retractor  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in liver function tests   Pre-operatively, Post-operatively at 24 hours, 1 week & 1 month 
Post-operative pain using visual analog score  Post-operatively at 8 hours, 24 hours & 48 hours 
Time for retractor insertion in minutes  Intra-operatively after placement of retractor 
 
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)   30/10/2024 
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 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  
As the world of laparoscopy is emerging with advent of technology, touch is being lost but visualization has improved. An optimal operative field view is crucial for increasing quality and safety of a laparoscopic surgical procedure. The laparoscopic approach has become the new normal because of reduced risk for wound complications and enhanced cosmesis.

Liver retraction is crucial for providing adequate visualization and working space around the stomach during laparoscopic bariatric surgery. In bariatric surgery, the retraction is particularly challenging as the method employed must have the ability to lift the heavy liver adequately. Liver retraction is traditionally achieved through insertion of an external retractor through a laparoscopic port (fan retractor) or an incision (Nathanson retractor). Mechanical liver retractors are known to cause retraction related transamnitis.

In the existing literature, there are comparative studies of various retraction methods in terms of operative field view, chances of liver injury and retraction related post-operative complications. However, majority of these studies are descriptive in nature and direct comparisons between instruments and techniques would be complicated. Several lacunae exist in the current literature about the comparability of use of fan retractor, in terms of operative field view, with the commonly used Nathanson retractor. 

Comparability studies related to operative field view as a primary objective need to be performed to define an optimal retractor in the Indian setting. In our study, in addition to operative view score, changes in the liver function tests and port/incision site pain post-operatively in two retraction groups will also be studied and compared. These studies would assist us in selecting appropriate device with optimal operative field view and less post-operative retraction related complications. 

 
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