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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 pneumoperitoneum | Experimental | Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg |
|
| Standard-pressure pneumoperitoneum | 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 |
|---|---|---|
| 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 | pre-op to 6 hours post 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 | pre op to 24 hours post -op |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | start to end of the study, 1 year |
| assessment of difference in operation time |
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Inclusion Criteria:
- Elective admission for laparoscopic cholecystectomy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | Jubaiha | 13046 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11304004 | Background | Reynolds W Jr. The first laparoscopic cholecystectomy. JSLS. 2001 Jan-Mar;5(1):89-94. | |
| 1386505 | Background | Soper NJ, Stockmann PT, Dunnegan DL, Ashley SW. Laparoscopic cholecystectomy. The new 'gold standard'? Arch Surg. 1992 Aug;127(8):917-21; discussion 921-3. doi: 10.1001/archsurg.1992.01420080051008. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2020 | Sep 3, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2020 | Aug 31, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| D010146 | Pain |
| 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 |
|
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 |
| start to end of the study, 1 year |
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| D013568 | Pathological Conditions, Signs and Symptoms |