Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy
NCT ID: NCT05530564
Last Updated: 2022-09-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-01-01
Study Completion Date
2021-01-30
Brief Summary
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The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.
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Detailed Description
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After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.
Conditions
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Pneumoperitoneum
Pain
Inflammatory Response
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
participants were divided into two masked groups, labelled red and green; those operated at low-pressure pneumoperitoneum (green-label) and those operated at standard-pressure pneumoperitoneum (red-label).
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
none of the participants knew at which pressure they will be operated on, nor the physicians who followed participants at floor or those analyzing blood samples, not the assigned physician to collect data, nor the personnel doing the analysis.
only the operating surgeon and circulating nurse were aware of the meaning of the participant assigned label at time of operation. The masking was revealed post completion of analysis.
only the operating surgeon and circulating nurse were aware of the meaning of the participant assigned label at time of operation. The masking was revealed post completion of analysis.
Study Groups
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Low-pressure pneumoperitoneum
Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg
Group Type
EXPERIMENTAL
low-pressure pneumoperitoneum
Intervention Type
PROCEDURE
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
Standard-pressure pneumoperitoneum
Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg
Group Type
ACTIVE_COMPARATOR
standard-pressure pneumoperitoneum
Intervention Type
PROCEDURE
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
Interventions
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low-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
Intervention Type
PROCEDURE
standard-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
\- Elective admission for laparoscopic cholecystectomy
Exclusion Criteria
* Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
* previous GI surgeries, except bariatric and anti-reflux surgeries
* Currently on immunosuppressant agents
* Pregnancy
* Breastfeeding
* Currently diagnosed with drug addiction
* American Society of Anesthesiologists (ASA) score 3 and more
* previous GI surgeries, except bariatric and anti-reflux surgeries
* Currently on immunosuppressant agents
* Pregnancy
* Breastfeeding
* Currently diagnosed with drug addiction
* American Society of Anesthesiologists (ASA) score 3 and more
Minimum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Jordan
OTHER
Sponsor Role
lead
Responsible Party
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Hanan Ibrahim Mansour
Dr. Hanan Mansour, M.D.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Jordan University Hospital
Amman, Jubaiha, Jordan
Site Status
Countries
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Jordan
References
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Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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10/2019/1115
Identifier Type: -
Identifier Source: org_study_id
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