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Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

Primary Purpose

Pneumoperitoneum, Pain, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
low-pressure pneumoperitoneum
standard-pressure pneumoperitoneum
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumoperitoneum focused on measuring Clinical trial, low pressure insufflation, pneumoperitoneum, laparoscopic cholecystectomy, pain, inflammatory marker

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-pressure pneumoperitoneum

Standard-pressure pneumoperitoneum

Arm Description

Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg

Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg

Outcomes

Primary Outcome Measures

assessment of pain with SPS-11 at 6hr post-op
measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op
change in IL-6
measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery

Secondary Outcome Measures

assessment of difficulty of surgery
to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult. analysis done using Chi-square cross table on SPSS V 1.0.0.1406
assessment of difference in operation time
to look for difference in operation time between the two groups, calculated in minutes. analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406

Full Information

First Posted
August 27, 2022
Last Updated
September 3, 2022
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT05530564
Brief Title
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy
Official Title
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum, Pain, Inflammatory Response
Keywords
Clinical trial, low pressure insufflation, pneumoperitoneum, laparoscopic cholecystectomy, pain, inflammatory marker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-pressure pneumoperitoneum
Arm Type
Experimental
Arm Description
Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg
Arm Title
Standard-pressure pneumoperitoneum
Arm Type
Active Comparator
Arm Description
Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg
Intervention Type
Procedure
Intervention Name(s)
low-pressure pneumoperitoneum
Intervention Description
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
Intervention Type
Procedure
Intervention Name(s)
standard-pressure pneumoperitoneum
Intervention Description
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
Primary Outcome Measure Information:
Title
assessment of pain with SPS-11 at 6hr post-op
Description
measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op
Time Frame
pre-op to 6 hours post op
Title
change in IL-6
Description
measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery
Time Frame
pre op to 24 hours post -op
Secondary Outcome Measure Information:
Title
assessment of difficulty of surgery
Description
to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult. analysis done using Chi-square cross table on SPSS V 1.0.0.1406
Time Frame
start to end of the study, 1 year
Title
assessment of difference in operation time
Description
to look for difference in operation time between the two groups, calculated in minutes. analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406
Time Frame
start to end of the study, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
State/Province
Jubaiha
ZIP/Postal Code
13046
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

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