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
|
|
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
|
|
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 |