An interventional study of low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in Pneumoperitoneum, Pain and Inflammatory Response, sponsored by University of Jordan. Completed at 1 site in Jordan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by University of Jordan · Not applicable, Interventional, and Treatment
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.
153 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 98 interventional studies indexed under Pneumoperitoneum.
Browse Pneumoperitoneum studies →University of Jordan is the lead sponsor of 130 studies on the registry; 20 are open to participants now.
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- Elective admission for laparoscopic cholecystectomy
Exclusion Criteria:
Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg
Procedure: low-pressure pneumoperitoneum
Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg
Procedure: standard-pressure pneumoperitoneum
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
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
Time frame: 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
Time frame: pre op to 24 hours post -op
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
Time frame: start to end of the study, 1 year
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
Time frame: start to end of the study, 1 year
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Ran from Jan 2020 to primary completion in Jan 2021, 12 months.
Of 44 non-industry interventional studies with no phase under Pneumoperitoneum, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's 12 months is above that.
Counting every sponsor, half of 45 studies reached it within 8 months; a quarter within 4 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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