Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?
NCT ID: NCT02049996
Last Updated: 2016-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
78 participants
OBSERVATIONAL
2014-01-31
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.
NCT03421067
Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications
NCT01033786
Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy
NCT00485355
Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy
NCT02741830
Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
NCT02859272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robotic-assisted prolapse repair
Subjects already scheduled for robotic-assisted prolapse repair in conjunction with vaginal hysterectomy
No interventions assigned to this group
Vaginal prolapse repair
Subjects already scheduled for vaginal prolapse repair in conjunction with vaginal hysterectomy.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
90 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TriHealth Inc.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lauren B. Westermann, DO
Role: PRINCIPAL_INVESTIGATOR
TriHealth Good Samaritan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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. doi: 10.1016/j.jmig.2007.06.008.
Bump RC, Mattiasson A, Bo 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. doi: 10.1016/s0002-9378(96)70243-0.
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. doi: 10.1016/j.jamcollsurg.2005.03.034.
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. doi: 10.1016/s0895-4356(98)00109-7.
Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
Saceanu S, Cela V, Surlin V, Angelescu CM, Patrascu S, Georgescu I, Genazzani A. Hysterectomy for benign uterine pathology: comparison between robotic assisted laparoscopy, classic laparoscopy and laparotomy. Chirurgia (Bucur). 2013 May-Jun;108(3):346-50.
Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Perioperative outcomes of robotic versus laparoscopic hysterectomy for benign disease. JSLS. 2013 Jan-Mar;17(1):100-6. doi: 10.4293/108680812X13517013317914.
Robinson BL, Parnell BA, Sandbulte JT, Geller EJ, Connolly A, Matthews CA. Robotic versus vaginal urogynecologic surgery: a retrospective cohort study of perioperative complications in elderly women. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):230-7. doi: 10.1097/SPV.0b013e318299a66c.
Crisp CC, Bandi S, Kleeman SD, Oakley SH, Vaccaro CM, Estanol MV, Fellner AN, Pauls RN. Patient-controlled versus scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a randomized trial. Am J Obstet Gynecol. 2012 Nov;207(5):433.e1-6. doi: 10.1016/j.ajog.2012.06.040. Epub 2012 Jun 20.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13090-13-060
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.