Pelvic Organ Prolapse Clinical Trial
— LLS vs SCPOfficial title:
Laparoscopic Lateral Suspension Versus Laparoscopic Sacral Colpopexy for Anterior and Apical Prolapse: an International Multicentric Randomized Trial
The aim of the study will be to compare the SCP and LLS in the management of apical prolapse at 6 weeks, 6 months, 1 year and yearly up to 2 years with the null hypothesis being that no significant differences existed between the two surgical procedures.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2024 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal or vault prolapse) - Women with or without anterior compartment prolapse (point Ba -1 or more pelvic organ prolapse quantification POP-Q) - Women without significant posterior compartment prolapse (point Bp -1 or more pelvic organ prolapse quantification POP-Q) Exclusion Criteria: - Women not eligible for surgery for medical or anesthesiological reasons - Inability to comprehend questionnaires - Inability to give informed consent - Inability to return for review - Prior laparoscopic prolapse repair - Prior vaginal mesh prolapse procedure - Vaginal length less than 6 cm. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical University of Vienna |
Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. Review. — View Citation
Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. 2013 Nov;24(11):1783-90. doi: 10.1007/s00192-013-2169-9. Review. — View Citation
Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. Epub 2004 Oct 21. — View Citation
Digesu GA, Santamato S, Khullar V, Santillo V, Digesu A, Cormio G, Loverro G, Selvaggi L. Validation of an Italian version of the prolapse quality of life questionnaire. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):184-92. — View Citation
Dubuisson JB, Yaron M, Wenger JM, Jacob S. Treatment of genital prolapse by laparoscopic lateral suspension using mesh: a series of 73 patients. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):49-55. doi: 10.1016/j.jmig.2007.11.003. — View Citation
Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of menopausal women. Am J Obstet Gynecol. 2004 Jan;190(1):27-32. — View Citation
Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10:CD012376. Review. — View Citation
Morrill M, Lukacz ES, Lawrence JM, Nager CW, Contreras R, Luber KM. Seeking healthcare for pelvic floor disorders: a population-based study. Am J Obstet Gynecol. 2007 Jul;197(1):86.e1-6. — View Citation
Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311. — View Citation
Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729. — View Citation
Veit-Rubin N, Digesu A, Swift S, Khullar V, Kaelin Gambirasio I, Dällenbach P, Boulvain M. Validation of the French version of the P-QoL questionnaire. Eur J Obstet Gynecol Reprod Biol. 2015 Sep;192:10-6. doi: 10.1016/j.ejogrb.2015.05.028. Epub 2015 Jun 10. — View Citation
Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17. — View Citation
Vieillefosse S, Thubert T, Dache A, Hermieu JF, Deffieux X. Satisfaction, quality of life and lumbar pain following laparoscopic sacrocolpopexy: suture vs. tackers. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:51-6. doi: 10.1016/j.ejogrb.2015.02.014. Epub 2015 Feb 18. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective cure rate of prolapse | Provided by the patient's feeling of the "Absence of a bulge in the vagina" | at 12 months postoperatively | |
Primary | Objective success | Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total | at 12 months postoperatively | |
Secondary | Patient global satisfaction | This will be assessed using a Visual Analogue Scale for Global Satisfaction (10=very satisfies, 0=entirely dissatisfied) | 1, 6, 12, 24 and 60 months | |
Secondary | Prolapse-related Quality of life | This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range). This will also help us in the follow up visits. |
1, 6, 12, 24 and 60 months | |
Secondary | Perioperative complications | This will be assessed using the Clavien-Dindo Scale. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life. |
perioperatively | |
Secondary | Sexual function | This will be assessed using a validated questionnaire (Prolapse/Incontinence Sexual Questionnaire-IUGA revised PISQ-IR) The PISQ-IR is a validated evaluation tool which can be used clinically as well as in research for assessment of female sexual function (FSF), in women with female pelvic floor disorders. The resultant scale is composed of six sub-scales in sexually active (SA) women and four in women who are not sexually active (NSA). For women who are SA, it contains 21 items covering six domains: arousal/orgasm, partner related, condition specific, global quality rating, condition impact, and desire. For women who are not SA, it contains 12 items covering four domains: condition specific, partner related, global quality, and condition impact. Each domain receives a separate score |
1, 6, 12, 24 and 60 months | |
Secondary | Patient satisfaction related to improvement of condition | This will be assessed using the Patient Global Impression Scale of Improvement (PGI-I) (6=very much improved condition, 1=condition worsened) | 1, 6, 12, 24 and 60 months |
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