Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
Study Details
Study Description
Brief Summary
The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair.
We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Since the introduction of the DaVinci robotic system (Intuitive Surgical, Sunnyvale, CA), there has been considerable debate regarding its use, cost-effectiveness, and subsequent impact on patient care. While some studies have examined surgical outcomes and analyzed costs of this technique compared to open, laparoscopic, and vaginal approaches, it remains unclear whether one route is superior.
Indeed, data evaluating robotic-assisted and laparoscopic approaches to hysterectomy have shown similar patient results, but some reports note higher costs and longer operating times with robotics. Others suggest contrary information, with comparable surgical time, reduced blood loss, shorter hospital stay, and lower rate of conversion to laparotomy using robotic-assisted hysterectomy compared to laparoscopic or abdominal. Research contrasting robot-assisted laparoscopic myomectomy with abdominal myomectomy posit greater cost associated with the robotic procedure, but enhanced benefit of decreased blood loss, complication rates, and length of stay.
However, these issues have not been explored in urogynecologic patients. A single study comparing robotic versus vaginal urogynecologic procedures in elderly women showed robotic surgery to be associated with fewer postoperative complications than the vaginal route. Nevertheless the procedures were not always performed in conjunction with hysterectomy, and the analysis was retrospective.
In our practice, vaginal hysterectomy is the preferred method when correcting uterovaginal prolapse. We then address the reconstruction either vaginally or robotically. Vaginal repairs are comprised of the following: a vaginal vault suspension using the uterosacral ligaments, enterocele repair, anterior repair, and posterior/rectocele repair. The robotic procedure performed is a robotic sacral colpopexy using lightweight, polypropylene mesh, as well as a posterior/rectocele repair transvaginally. Both of these techniques are well-researched, effective approaches to addressing prolapse in a durable way. However, it is not clear whether one is superior in patient-related quality of life outcomes. We seek to compare patient quality of life by assessing differences in subjective impressions of pain following these procedures
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Robotic-assisted prolapse repair Subjects already scheduled for robotic-assisted prolapse repair in conjunction with vaginal hysterectomy |
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| Vaginal prolapse repair Subjects already scheduled for vaginal prolapse repair in conjunction with vaginal hysterectomy. |
Outcome Measures
Primary Outcome Measures
- Subjective assessment of pain on the morning of post-operative day 1 [One day (the day after surgery)]
Subjective assessment of pain on the morning of post-operative day 1, prior to discharge, on a 150 mm visual analog scale (Surgical Pain Scale) The average pain that day at rest and the WORST pain that day will be the primary outcomes of pain.
Secondary Outcome Measures
- Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit [2 week postoperative visit]
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit on a 150 mm visual analog scale (Surgical Pain Scale).
- Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit [6 week postoperative visit]
Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit on a 150 mm visual analog scale (Surgical Pain Scale).
- Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit [1 day (Baseline, day of surgery)]
General Health Survey- Short Form 12 looking at quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
- Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit. [2 week postoperative visit]
General Health Survey- Short Form 12 looking at quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
- Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit. [6 week postoperative visit]
General Health Survey- Short Form 12 looking at quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
- Intraoperative time [Intraoperative]
Length of surgery
- Estimated blood loss [Intraoperative]
Estimated blood loss during surgery.
- Surgical complications [Intraoperative]
Complications that occur during surgery.
- Voiding trial results [1 day (day after surgery)]
Results of voiding trial which assesses postoperative bladder function.
- Hospital length of stay [1-2 days]
Length of stay in the hospital for surgery and postoperative care.
- POP-Q preoperatively and postoperatively [several weeks]
Comparison measurement of prolapse using pelvic organ prolapse quantification scale (POP-Q) preoperatively and postoperatively.
- Hemoglobin/hematocrit measurement [1 day (postoperative day 1)]
Measurement of blood count (hemoglobin/hematocrit levels) on postoperative day 1.
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients of Cincinnati Urogynecology Associates
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aged 18-90
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planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal.
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undergoing general anesthesia
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able to speak and read English
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able to understand the informed consent statement
Exclusion Criteria:
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scheduled for repairs not involving a hysterectomy
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use of mesh in the vaginal prolapse repair
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obliterative procedures to the vagina
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concurrent removal of a suburethral sling
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anterior, posterior or apical vaginal mesh kit at the time of their surgery
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performance of vaginal 'relaxing incisions' at the time of vaginal surgery
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concurrent anal incontinence repair such as a sphincteroplasty
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presence of uterine, cervical or ovarian malignancy
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use of regional anesthesia for their surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TriHealth Good Samaritan Hospital | Cincinnati | Ohio | United States | 45220 |
Sponsors and Collaborators
- TriHealth Inc.
Investigators
- Principal Investigator: Lauren B. Westermann, DO, TriHealth Good Samaritan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Advincula AP, Xu X, Goudeau S 4th, Ransom SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):698-705.
- Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7.
- Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8.
- McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. Erratum in: J Am Coll Surg. 2005 Nov;201(5):826.
- Orady M, Hrynewych A, Nawfal AK, Wegienka G. Comparison of robotic-assisted hysterectomy to other minimally invasive approaches. JSLS. 2012 Oct-Dec;16(4):542-8. doi: 10.4293/108680812X13462882736899.
- Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. Epub 2008 Mar 6.
- Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.
- 13090-13-060