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CTRI Number  CTRI/2019/02/017490 [Registered on: 06/02/2019] Trial Registered Prospectively
Last Modified On: 15/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the severity of abdominal pain and shoulder tip pain in low versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. 
Scientific Title of Study   Randomized Control Trial to study the severity of abdominal pain and shoulder tip pain in low versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Major Dr Rahul Sandhu 
Designation  Resident General Surgery 
Affiliation  AFMC Pune 
Address  Department of Surgery AFMC Pune

Pune
MAHARASHTRA
411040
India 
Phone  9888970519  
Fax    
Email  drasandhu@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Major Dr Rahul Sandhu 
Designation  Resident General Surgery 
Affiliation  AFMC Pune 
Address  Department of Surgery AFMC Pune

Pune
MAHARASHTRA
411040
India 
Phone  9888970519  
Fax    
Email  drasandhu@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Major Dr Rahul Sandhu 
Designation  Resident General Surgery 
Affiliation  AFMC Pune 
Address  Department of Surgery AFMC Pune

Pune
MAHARASHTRA
411040
India 
Phone  9888970519  
Fax    
Email  drasandhu@yahoo.co.in  
 
Source of Monetary or Material Support  
COLLEGE FUNDED, ARMED FORCES MEDICAL COLLEGE 
 
Primary Sponsor  
Name  ARMED FORCES MEDICAL COLLEGE 
Address  PUNE 411040 
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 
BRIG DR SITARAM GHOSH   ARMED FORCES MEDICAL COLLEGE  DEPARTMENT OF SURGERY, FIRST FLOOR
Pune
MAHARASHTRA 
8551047907

sitaram.ghosh@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, AFMC  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LOW PRESSURE PNEUMOPERITONEUM  TO STUDY THE SEVERITY OF ABDOMINAL PAIN AND SHOULDER TIP PAIN IN LOW VERSUS STANDARD PRESSURE PNEUMOPERITONEUM DURING LAPAROSCOPIC CHOLECYSTECTOMY.  
Comparator Agent  STANDARD PRESSURE PNEUMOPERITONEUM  TO STUDY THE SEVERITY OF ABDOMINAL PAIN AND SHOULDER TIP PAIN IN LOW VERSUS STANDARD PRESSURE PNEUMOPERITONEUM DURING LAPAROSCOPIC CHOLECYSTECTOMY.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ALL PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY 
 
ExclusionCriteria 
Details  i. Rupture of gallbladder,
ii. Empyema,
iii. Common bile duct stones,
iv. Patients undergoing extensive upper abdominal surgery,
v. Pregnant females, patients with body mass index (BMI) >30 and <19,
vi. Fatty liver grade 3 and 4,
vii. Elevated liver enzymes before the surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1. To study the hemodynamic changes in standard versus low pressure LC patients.
2. To study the level of abdominal pain in standard versus low pressure LC patients.
 
1,3,6,12,24 hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the risk factor and complication involved in the two group of patients.
2. To study the changes in liver enzymes among the two groups of patients.
 
1,3,6,12,24 hours post surgery 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/02/2019 
Date of Study Completion (India) 20/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Biliary diseases known since ages constitute a major portion of digestive tract disorders world over and Gallstone disease is a major cause of abdominal morbidity and mortality.1 Almost 10% of the population has gallstones, and cholecystectomy is the most common surgical method to treat it in the Western countries.2  However, today, the laparoscopic cholecystectomy (LC) is the gold standard to treat gallstones and has replaced the open cholecystectomy that now remains a choice only in some complicated cases.

Laparoscopy cholecystectomy was first introduced by Dubois in 1988 and gradually developed by monitor and video systems.3,4 But for clear visualisation of surgical site during LC; pneumoperitoneum has to be created.5 In modern minimal access surgery worldwide, Carbon dioxide is the commonest means of achieving pneumoperitoneum and it is the same gas responsible for postoperative shoulder tip pain whose reported incidence is 30 to 50% in patients following laparoscopic cholecystectomy.6 It is now well documented that physiologic changes in cardiovascular system, respiratory system, and blood chemistry occur during creation of pneumoperitoneum. These changes usually are associated with either increased intra-abdominal pressure or with use of CO2.7

The adverse events reported with pneumoperitoneum include decreased pulmonary compliance, altered blood gas parameters, impaired functioning of the circulatory system, raised liver enzymes and renal dysfunction and increased intra-abdominal venous pressures. The duration of convalescence after uncomplicated laparoscopic cholecystectomy depend on several factors of which shoulder tip pain is more important. Other are nausea, vomiting, ileus, postoperative fatigue, postoperative hospital stays, recovery time.8 The current trend is to employ low pressure laparoscopic cholecystectomy (LPLC). While standard pressure pneumoperitoneum, employs a pressure range of 12-14 mm Hg, the low pressure pneumoperitoneum ranges from 7-10 mm Hg. Low pressure technique was attempted to

lower the impact of pneumoperitoneum like CO2 embolism, vaso-vagal reflex, cardiac arrhythmia, hypercarbic acidosis and minimizes haemodynamic effect of insufflation.

 

However, most important drawback of applying low pressure is the inadequate exposure of the operating space that can result in longer than usual operating time, higher rate of intraoperative complications and also possibly higher frequency of conversion to standard pressure laparoscopic cholecystectomy (SPLC) or open cholecystectomy.1

Several studies have compared the effects of reduced pressure (7-9 mm Hg) with standard pressure (12-15 mm Hg) during LC. These studies illustrate the feasibility of low pressure PP, along with some advantages in terms of postoperative pain.9

Thus, the present study was designed to study the level of abdominal pain and shoulder tip

pain post surgery in two groups of patients undergoing LPLC and SPLC

 
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