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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-pressure | Experimental | Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg |
|
| Standard-pressure | Active Comparator | Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-pressure pneumoperitoneum | Procedure | insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op | the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 12-hr post-op) - (baseline pain score assessed at 6-hr post-op) | baseline and 12 hours post-op |
| change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op | the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 24-hr post-op) - (baseline pain score assessed at 6-hr post-op) | baseline and 24 hours post-op |
| change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op | the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at post-op day 7) - (baseline pain score assessed at 6-hr post-op) | baseline and 7 days post-op |
| change from baseline in WBC count at 24hr post op | calculate the rise in white blood cycles count as inflammatory marker post-op in 1000 cells per cubic millimeter of blood. change = (post-op WBC count) - (baseline WBC count) | baseline and 24 hours post-op |
| change from baseline in Plt count at 24hr post op | calculate the rise in platelets count as inflammatory marker post-op in × 10^9/L of blood change = (post-op Plt count) - (baseline Plt count) | baseline and 24 hours post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in surgery difficulty level among two groups | assessing level of surgery difficulty between low and standard pressure pneumoperitoneum groups. Difficulty was self reported by operating surgeon as easy (score=1), moderate (score=2), or difficult (score=3). Difference assessed by calculating average between groups | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salam Daradkeh, Prof. | University of Jordan | Study Chair |
| Mohammad Rashdan, Prof. | University of Jordan | Principal Investigator |
| Raed Al-Taher, Prof. | University of Jordan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | Jubaiha | 13046 | Jordan |
we are willing to share all study data for interested researchers to conduct secondary studies of their own.
the data will be available from April,2021 up to the end of 2021 year
Data will be shared for medical investigators interested in the topic of pneumoperitoneum, to request please contact (hanan.ju@gmail.com)
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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).
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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.
| standard-pressure pneumoperitoneum | Procedure | insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg |
|
| change from baseline in ESR value at 24hr post op |
calculate the rise in erythrocyte sedimentation rate value as inflammatory marker post-op in millimeters per hour. change = (post-op ESR) - (baseline ESR) |
| baseline and 24 hours post-op |
| change from baseline in CRP level at 24hr post op | calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP) | baseline and 24 hours post-op |
| change from baseline in Alb level at 24hr post op | calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb) | baseline and 24 hours post-op |
| change from baseline in cortisol level at 4hr post op | calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol ) | baseline and 4 hours post-op |
| change from baseline in IL-6 level at 24hr post op | calculate the rise in interleukin 6 level as inflammatory marker post-op in pg/mL change = (post-op IL-6) - (baseline IL-6) | baseline and 24 hours post-op |
| change from baseline in IL-17 level at 24hr post op | calculate the rise in interleukin 17 level as inflammatory marker post-op in pg/mL change = (post-op IL-17) - (baseline IL-17) | baseline and 24 hours post-op |
| change from baseline in IL-1 level at 24hr post op | calculate the rise in interleukin 1 level as inflammatory marker post-op in pg/mL change = (post-op IL-1) - (baseline IL-1) | baseline and 24 hours post-op |
| change from baseline in TNF level at 24hr post op | calculate the rise in tumor necrosis factor alpha level as inflammatory marker post-op in pg/mL change = (post-op TNF) - (baseline TNF) | baseline and 24 hours post-op |
| Difference in surgery time among two groups | assessing difference in insufflation time calculated in minutes between low and standard pressure pneumoperitoneum groups. insufflation time was calculated from time of creation of pneumoperitoneum to deflation of the abdomen. Difference assessed by calculating average between groups | through study completion, an average of 1 year |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |