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CTRI Number  CTRI/2023/11/059491 [Registered on: 03/11/2023] Trial Registered Prospectively
Last Modified On: 02/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Low Pressure Pneumoperitoneum with Standard Pressure Pneumoperitoneum to determine which one is better regarding pain experienced by patient in post operative period 
Scientific Title of Study   A Study comparing the effects and outcomes with Low Pressure Pneumoperitoneum Versus Standard Pressure Pneumoperitoneum in Laparoscopic Cholecystectomy 
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 Vishesh Gupta 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Dept. of General Surgery, PGIMER, SECTOR-12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9899633836  
Fax    
Email  vishesh.gupta65@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Cherring Tandup 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Dept. of General Surgery, PGIMER, SECTOR-12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8196991007  
Fax    
Email  ctandup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishesh Gupta 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Dept. of General Surgery, PGIMER, SECTOR-12, Chandigarh


CHANDIGARH
160012
India 
Phone  9899633836  
Fax    
Email  vishesh.gupta65@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh Adminitration 
Address  PGIMER, Sector-12, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Vishesh Gupta  Postgraduate Institute of Medical Education and Research, Chandigarh  Dept. of General Surgery, Block-B, 5th Floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 
9899633836

vishesh.gupta65@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural), PGIMER, Chandigarh  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low Pressure pneumoperitoneum  The total cohort of the study, after obtaining written informed consent, will be randomly assigned to either of the groups (LPP defined as those in whom pneumoperitoneum pressure is 8 to 10 mm Hg or SPP in whom pneumoperitoneum pressure is 13 to 15 mm Hg).  
Comparator Agent  Standard Pressure Pneumoperitoneum  • The total cohort of the study, after obtaining written informed consent, will be randomly assigned to either of the groups (LPP defined as those in whom pneumoperitoneum pressure is 8 to 10 mm Hg or SPP in whom pneumoperitoneum pressure is 13 to 15 mm Hg).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All patients with symptomatic GSD with chronic cholecystitis undergoing elective laparoscopic cholecystectomy
2. Age: 18years- 65 years
 
 
ExclusionCriteria 
Details  1. Patients not giving consent for undergoing study
2. Patients with other preoperative causes of shoulder pain like bursitis, rheumatoid arthritis, tendinitis and other musculoskeletal conditions
3. Patients with CAD, COPD, Asthma, previous malignancy, jaundice or any other co-morbidity
4. Patients who have underwent any abdominal surgery previously
5. BMI<18.5 or BMI>29.9
6. Patients on chronic analgesic use or patients with history of addiction to alcohol
7. Patients with significant portal hypertension, uncorrectable coagulopathies, cirrhosis and generalized peritonitis
8. Pregnant patients
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence & intensity of post-operative pain & analgesic requirement in LPP group & SPP group  6hrs 12hrs 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
duration of procedure   At end of surgery 
surgical field visualization  At end of surgery 
incidence of intra-operative complications  At end of surgery 
Effect of pneumoperitoneum on Intra-operative physiology  i. At insufflation of pneumoperitoneum
ii. 30 minutes after insufflation
iii. Just before reversal of general anaesthesia 
duration of hospital stay & time taken for return to work  Up to 30 days after surgery 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3/ Phase 4 
Date of First Enrollment (India)   11/11/2023 
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="0"
Months="4"
Days="17" 
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  

Laparoscopic cholecystectomy has replaced conventional cholecystectomy as there are limited surgical incisions, decreased post-operative stay, less post-operative pain and decreased need for post-operative analgesia4-6.

 

Traditionally, one of the first steps in laparoscopic cholecystectomy is the creation of pneumoperitoneum7 using carbon dioxide (CO2) through Veress needle8 or through a port (hole) in the abdominal wall. Traditionally, the pressure used is around 15mm Hg (12-16 mm Hg)9.

 

The commonly seen complications due to pneumoperitoneum are shoulder tip pain and cardiopulmonary changes. These changes seen are directly due to pressure effects on peritoneum and diaphragm and indirectly due to absorbed carbon dioxide and hypercarbia, leading to local peritoneal acidosis, increased intrathoracic pressure, decreased venous return, and decreased cardiac output. These complications may be well tolerated by healthy and young individuals but lead to significant complications in old and those who have underlying cardiopulmonary diseases.

 

The increase in intrathoracic pressure depends to some extent on the pressure maintained in pneumoperitoneum due to upward compressive effects of diaphragm. This led researchers to think in term of low-pressure pneumoperitoneum cholecystectomies.

 

International guidelines recommend that the use of “the lowest intra-abdominal pressure allowing adequate exposure of operative field rather than a routine pressure” should be used to minimize the impact of pneumoperitoneum on normal physiology and the positive impact on postoperative pain10. Low pressure pneumoperitoneum is defined as a pressure of 6-10mm Hg11. The main concern about low pressure pneumoperitoneum is its safety in terms of inadequate exposure resulting in longer than usual operating time, increased rate of intra-operative complications and also possibly increased frequency of conversion to open cholecystectomy12. Therefore, attempts are made to use low pressure pneumoperitoneum in range of 6-10mm Hg in an attempt to minimize alteration of normal physiology and simultaneously to provide an adequate working space.

 

 

In present study outcome of the use of low-pressure pneumoperitoneum (LPP defined as 8-10mm Hg in our study) in comparison to the use of standard pressure pneumoperitoneum (SPP defined as 13-15mm Hg in this study) in patients undergoing laparoscopic cholecystectomy are studied.

 

The aim of the current study is to evaluate and compare the effects and outcomes of LPP versus SPP in laparoscopic cholecystectomy.

                       

 
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