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โ† Trials
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Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain

RecruitingNAAges 18 Years - anyFemaleMount Sinai Hospital, Canada
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In plain words

What the trial is, and whether it could suit you

This proposed study is a single-center, double blind, parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Patients will be randomized to the control group (standard pressure) or the intervention group (low pressure) and surgeons will be blinded to the study pressure. Data on post-operative recovery and pain scores will be recorded for each patient.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: The participant must meet all of the inclusion criteria to eligible for this clinical trial: 1. All ages \> or = to 18 years old; 2. Must be deemed to have capacity to provide informed consent; 3. Must sign and date the informed consent form; 4. Stated willingness to comply with all study procedures; 5. Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy; Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this clinical trial: 1. Previous midline laparotomy; 2. Gynecological cancer beyond stage 1 disease; 3. Chronic pain; 4. Known diagnosis of endometriosis or evidence of endometriosis intra-operatively; 5. Fibromyalgia; 6. BMI \>50; 7. Language barrier; 8. Inability to communicate or provide informed consent;
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What it tests

  • Low Pressure Penumoperitoneum
  • Standard Pressure Group (No intervention- active comparator)
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Where

1 site
Women's College Hospital
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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