| 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
|
|
|
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
|
|
|
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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