This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.
This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine \& Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
This is the amount of insufflation using during the surgical procedure.
Ascension St. John Hospital
Detroit, Michigan, United States
RECRUITINGPost-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Pain will be assessed during the 24-hour post-operative period.
Time frame: Pain will be assessed within 24 hours of the surgery. .
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Pain will be assessed during the two-week post-operative period.
Time frame: Pain will be assessed at the two-week post-operative follow-up visit.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
The safety of the lower insufflation pressure will be assessed during the procedure.
Time frame: Safety will be assessed during the procedure.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
The safety of the lower insufflation pressure will be assessed immediately post-operatively.
Time frame: Safety will be assessed immediately post-operatively.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.
Time frame: Safety will be assessed at the two-week follow-up visit.
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