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CTRI Number  CTRI/2024/07/071458 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Postoperative Recovery and Inflammatory markers in Low vs. Standard Pressure Pneumoperitoneum among Laparoscopic Cholecystectomy Patients. 
Scientific Title of Study   Effect of Low-Pressure Pneumoperitoneum versus Standard Pressure on Post-operative discomfort and changes in various Inflammatory markers in Laparoscopic Cholecystectomy: A Randomized Control Trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SWATI PRASAD 
Designation  Academic junior resident 
Affiliation  All India Institute of Medical Science Gorakhpur. 
Address  Room no:101 OPD Block ,General Surgery Department AIIMS Gorakhpur Kunarghat
Room no :103 OPD block ,General Surgery Department AIIMS Gorakhpur Kunarghat
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  7488378703  
Fax    
Email  drswatiprasad29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Dharmendra Kumar Pipal 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
Address  Room no:101 OPD Block ,General Surgery Department AIIMS Gorakhpur Kunarghat
Room no:101 OPD Block ,General Surgery Department AIIMS Gorakhpur Kunarghat
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  7488378703  
Fax    
Email  dr.dharmendrapipal2007@gmail.com  
 
Details of Contact Person
Public Query  
Name  SWATI PRASAD 
Designation  Academic junior resident 
Affiliation  All India Institute of Medical Science Gorakhpur. 
Address  Room no:101 OPD Block ,General Surgery Department AIIMS Gorakhpur Kunarghat
General Surgery Department OPD Room No:101 AIIMS Gorakhpur Kunarghat Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  7488378703  
Fax    
Email  drswatiprsad29@gmail.com  
 
Source of Monetary or Material Support  
General Surgery Department OPD Room No:101 AIIMS Gorakhpur Kunarghat Gorakhpur 
 
Primary Sponsor  
Name  AIIMS Gorakhpur 
Address  Room no:101 OPD Block ,General Surgery Department AIIMS Gorakhpur Kunarghat, Postal Code :273008 Uttar Pradesh , INDIA. Pin 273008 Kunarghat Gorakhpur 
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 SWATI PRASAD  All India Institute of Medical Sciences  Room No:101, OPD Block, Department of General Surgery
Gorakhpur
UTTAR PRADESH 		 7488378703

drswatiprasad29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (4) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low Pressure Pneumoperitoneum/ Group A   They will be scheduled to undergo laparoscopic cholecystectomy at a low-pressure Laparoscopic cholecystectomy (LPLC), that is defined as a gas insufflation set point between 8 and 10 mmHg. 
Comparator Agent  Standard Pressure/ Group B  They will be scheduled to undergo laparoscopic cholecystectomy at a standard-pressure Laparoscopic Cholecystectomy (SPLC), that is defined as gas insufflation set point between 12 and 14 mmHg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Any age ranges from 18 to 60 years old.

2. Both sex included with Low Anesthetic Risk Score of 1 or 2 according to the American Society of Anesthesiologists (ASA).

3. Mild to moderate cholecystitis and simple symptomatic gallbladder stone disease, as confirmed by USG. 
 
ExclusionCriteria 
Details  1. Gall bladder malignancy.

2. Acute cholecystitis.

3. Choledocholithiasis.

4. H/O ERCP with and without a stent in place.

5. Other causes of shoulder pain such subacromial bursitis, rheumatoid arthritis, tendinitis, and other musculoskeletal conditions;
coronary artery diseases; COPD; asthma; history of cancer; jaundice; or any other co-morbidity.

6. Who had previous upper abdomen surgery.

7. BMIs below 18.5 or above 29.9.

8. ASA grades III, IV, or ,V.

9. Cognitive impairment, long-term painkiller use, or a history of alcohol addiction.

10. People who have been found with acute cholecystitis by ultrasonography or who have had it in the past.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To determine if there is a significant difference in pain levels, as measured by the Visual Analogue Score (VAS), at four pre determined time points: 6hours, 12 hours, 24 hours, and 7 days post-operation among patients undergoing laparoscopic cholecystectomy with low-
pressure pneumoperitoneum compared to standard pressure.
2.To evaluate significant changes in inflammatory markers from baseline values in the same patient population. 		 6hours, 12 hours, 24 hours, and 7 days Post-Laparoscopic Cholecystectomy 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare theneed for additional pain medicationpost-operationbetween the low-pressure and standard-pressure pneumoperitoneum groups.
To record and compare the length of time the surgery takes under low-pressure versus standard-pressure pneumoperitoneum.
To evaluate and compare the level of difficulty experienced by the surgeon during the procedure in both groups
To note and compare the necessity of placing adrain during or after the surgery in both patient groups.
To monitor and compare the length ofthe hospital stay post-surgery between thetwo groups. 		 intra op ,6hr,12hr,24hr and 7 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   12/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/08/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drswatiprasad29@gmail.com].

  6. For how long will this data be available start date provided 05-08-2027 and end date provided 04-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nill
Brief Summary   TITLE:Effect of low pressure pneumoperitoneum on postoperative discomfort and changes  in various inflammatory markers in laparoscopic cholecystectomy :a randomized controlled trial
OBJECTIVE:
PRIMARY OBJECTIVE-To analyse the significant difference in pain using the visual analogue score at four set point (6 hr,12hr,24hr,7 days post op) & to observe a significant change in the collected in the collected inflammatory markers from baseline.
secondary objectives:To assess the requirement of analgesia, duration of surgery ,difficulty observed by the surgeon, the need for putting a drain ,and the overall duration of stay in the hospital following the surgery.
METHODOLOGY AND STUDY DESIGN :This study is randomised, single -blinded control trial involving 100 patients admitted to the surgery department of all India institute of medical sciences ,Gorakhpur .,over 2 yr duration.Patients meeting the inclusion- exclusion  criteria will be randomized into two groups:GROUP A(interventional group ):Scheduled for laparoscopic cholecystectomy at low-pressure(8-10 mm hg ).Group B(control group ):Scheduled for laparoscopic cholecystectomy at standard -pressure (12-14 mm hg).
INCLUSION CRITERIA :Participants aged 18yr to 60 yr  regardless of gender ,with a low anesthetic risk score of 1 or 2 according to the American Society of Anaesthesiologists (ASA),and having mild to moderate  cholecystitis and simple symptomatic gallbladder stone disease as confirmed by ultrasonography.
EXCLUSION CRITERIA:Patient with gall bladder malignancy ,acute cholecystitis ,ERCP with and without a stent in place among other specific condition .
EXPECTED OUTCOME :The study aims to establish whether low-pressure pneumoperitoneum can be a new standard of care for laparoscopic cholecystectomy in patient with mild to moderate gallstone disease .It is expected to evaluate the efficacy and safety to low-pressure pneumoperitoneum in reducing postoperative pain and inflammation ,potentially leading to recommendations for changes in surgical practice to improve patient outcomes.
 
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