Pelvic Organ Prolapse
Conditions
Keywords
Sacrocolpopexy, Pneumoperitoneum, Postoperative pain
Brief summary
This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.
Detailed description
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.
Interventions
PROCEDUREInsufflation during surgery
This is the amount of insufflation using during the surgical procedure.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.
Intervention model description
Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse. * Age 18-90 years * Can read and understand the consent form and consents to the procedure
Exclusion criteria
* Patients undergoing other procedures * Patients who do not consent to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain. | Pain will be assessed within 24 hours of the surgery. . | Pain will be assessed during the 24-hour post-operative period. |
| Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes. | Safety will be assessed during the procedure. | The safety of the lower insufflation pressure will be assessed during the procedure. |
Countries
United States
Outcome results
None listed