Clinical trial NCT02049996: Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
Official title: Is There a Difference in Pain and Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Compared to Robotic Colpopexy? A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Quality of life
Robotic surgery
Vaginal surgery
Prolapse repair
Vaginal hysterectomy
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been scheduled for a vaginal hysterectomy with either vaginal or robot-assisted prolapse repairs with Cincinnati Urogynecology Associates will be approached for participation in the study.

Eligible subjects are patients of Cincinnati Urogynecology Associates, aged 18-90, 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. All subjects will undergo general anesthesia. Eligible subjects must be able to speak and read English, and be able to understand the informed consent statement.

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.

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

Eligibility criteria: Inclusion Criteria:

* patients of Cincinnati Urogynecology Associates
* aged 18-90
* 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.
* undergoing general anesthesia
* able to speak and read English
* able to understand the informed consent statement

Exclusion Criteria:

* scheduled for repairs not involving a hysterectomy
* use of mesh in the vaginal prolapse repair
* obliterative procedures to the vagina
* concurrent removal of a suburethral sling
* anterior, posterior or apical vaginal mesh kit at the time of their surgery
* performance of vaginal 'relaxing incisions' at the time of vaginal surgery
* concurrent anal incontinence repair such as a sphincteroplasty
* presence of uterine, cervical or ovarian malignancy
* use of regional anesthesia for their surgery.

Primary outcomes:
measure: Subjective assessment of pain on the morning of post-operative day 1
timeFrame: One day (the day after surgery)
Secondary outcomes:
measure: Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit
timeFrame: 2 week postoperative visit
measure: Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit
timeFrame: 6 week postoperative visit
measure: Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit
timeFrame: 1 day (Baseline, day of surgery)
measure: Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
timeFrame: 2 week postoperative visit
measure: Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.
timeFrame: 6 week postoperative visit
measure: Intraoperative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Surgical complications
timeFrame: Intraoperative
measure: Voiding trial results
timeFrame: 1 day (day after surgery)
measure: Hospital length of stay
timeFrame: 1-2 days
measure: POP-Q preoperatively and postoperatively
timeFrame: several weeks
measure: Hemoglobin/hematocrit measurement
timeFrame: 1 day (postoperative day 1)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Good Samaritan Hospital
name: Lauren B. Westermann, DO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Westermann LB, Crisp CC, Mazloomdoost D, Kleeman SD, Pauls RN. Comparative Perioperative Pain and Recovery in Women Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):95-100. doi: 10.1097/SPV.0000000000000368.