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
|
|
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
|
|
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 pressureâ€
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.
|