Actively Recruiting
Comparison of Low Pressure versus High Pressure Pneumoperitoneum in Post-operative Pain and Common Bile Duct Injuries During Laparoscopic Cholecystectomy
Led by Gulab Devi Hospital · Updated on 2024-12-04
82
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the rates of pain and common bile duct injuries in patients undergoing laparoscopic gallbladder removal surgery using either low pressure or high pressure pneumoperitoneum. Laparoscopic cholecystectomy is a common minimally invasive procedure to treat gallstones and related conditions, with millions performed annually. The study addresses how different pressure levels during surgery may affect post-operative pain, including shoulder pain, and the risk of bile duct injury, which is a serious complication with increased incidence in laparoscopic techniques. The study compares two groups: one receiving low-pressure pneumoperitoneum at pressures between 6 and 10 mmHg, and the other receiving high-pressure pneumoperitoneum at 12 to 15 mmHg or higher. Pneumoperitoneum is created by introducing carbon dioxide gas into the abdomen to allow better visualization and surgical access. While high pressure may improve surgical view and reduce operative time, it is linked to more post-operative pain and discomfort. Low pressure aims to reduce pain, though it may increase surgery duration due to reduced visibility. The study evaluates these pressure settings to determine their impact on pain and bile duct injury during laparoscopic cholecystectomy. Participants will undergo laparoscopic cholecystectomy with assigned pneumoperitoneum pressure. Researchers will monitor the incidence of post-operative pain and common bile duct injuries over six months. Assessments will include pain measurements and surgical outcomes related to bile duct safety. The study involves random assignment to either low or high pressure groups and single masking. Follow-up will track pain levels and bile duct complications to evaluate differences between the two pressure approaches. The overall goal is to improve patient comfort and safety during this common surgery.
CONDITIONS
Brief Title
Comparison Between Low Pressure Pneumoperitoneum with High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any gender
- Patients undergoing laparoscopic cholecystectomy for cholelithiasis (gallstones)
You will not qualify if you...
- Patients with cardiac abnormalities
- Patients with previous abdominal surgeries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay
Participants undergo laparoscopic cholecystectomy with either low-pressure or high-pressure pneumoperitoneum and receive immediate post-operative care.
1 surgical procedure visit and hospital stay
Duration - Up to 6 months
Participants are monitored for post-operative pain, shoulder tip pain, and common bile duct injuries after surgery.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Gulab Devi Hospital
Lahore, PUN, Pakistan, 54000
Actively Recruiting
Research Team
Z
Zain Himayoun, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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