Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMount Sinai Hospital, Canada
About this trial
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.
Eligibility criteria
Qualifiers
All ages > or = to 18 years old;
Must be deemed to have capacity to provide informed consent;
Must sign and date the informed consent form;
Stated willingness to comply with all study procedures;
Disqualifiers
Previous midline laparotomy;
Gynecological cancer beyond stage 1 disease;
Chronic pain;
Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
Trial design
Treatments tested in this trial
- Low Pressure Penumoperitoneum
- Standard Pressure Group (No intervention- active comparator)
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mount Sinai Hospital, Canada
Lead sponsor
Women's College Hospital
Collaborator
Source ClinicalTrials.gov