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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Insufflation Group | Active Comparator | Patients will receive standard insufflation during surgery (15 mm Hg). |
|
| Low Insufflation Group | Experimental | Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insufflation during surgery | Procedure | This is the amount of insufflation using during the surgical procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 24-hour post-operative period. | 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. | 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. | 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. | 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. | Safety will be assessed at the two-week follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
This procedure only applies to women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Rustia, MD | Contact | 313-343-6708 | gabriella.rustia@ascension.org | |
| Muhammad F Aslam, MD | Contact | 313-343-3494 | muhammad.aslam@ascension.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension St. John Hospital | Recruiting | Detroit | Michigan | 48236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37348093 | Derived | Rustia GM, Baracy MG Jr, Khair E, Hagglund KH, Aslam MF. Pain With Differing Insufflation Pressures During Robotic Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011027 | Pneumoperitoneum |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010532 | Peritoneal Diseases |
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Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
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Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |