Dataset Information

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

ABSTRACT:

Background

Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman's quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III-IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness.

Methods

The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (β = 0.2 and one-sided α = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair.

Discussion

This multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III-IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective.

Trial registration

ClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.

SUBMITTER: Chen J

PROVIDER: S-EPMC7045611 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

Chen Juan J Yu Jiajie J Morse Abraham A Fünfgeld Christian C Huang Kuanhui K Gong Jian J Tao Guangshi G Wang Binan B Wang Yuling Y Jiang Xiangyang X Ababaikeli Gulina G Liu Peishu P Nisier Hatiguli H Zhang Xiaowei X Wang Ping P Sun Xin X Zhu Lan L

Trials 20200226 1

<h4>Background</h4>Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman's quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh p ...[more]

PMID: 32102687

Similar Datasets

Project description:ImportanceTransvaginal mesh (TVM) can increase the durability of vaginal surgical procedures for pelvic organ prolapse (POP) and may be indicated in certain situations despite concerns about mesh-related complications. In addition, the expense of commercial mesh kits has limited their use. The effectiveness, safety, and cost of a self-cut mesh procedure compared with a commercial mesh-kit procedure for the surgical treatment of women with POP is unclear.ObjectiveTo assess the 1-year effectiveness and safety of self-cut titanium-coated polypropylene mesh compared with a precut commercial mesh kit for the transvaginal surgical treatment of women with severe symptomatic POP.Design, setting, and participantsThis multicenter randomized noninferiority clinical trial was conducted at 11 hospitals in 8 provinces of China. A total of 336 women with symptomatic stage 3 to 4 POP were enrolled between January 22, 2018, and November 11, 2019, with follow-up through December 11, 2020.InterventionsParticipants were randomized to receive a TVM procedure using either self-cut mesh (self-cut mesh group) or a precut commercial mesh kit (mesh-kit group), both of which used the same titanium-coated polypropylene mesh.Main outcomes and measuresThe primary outcome measure was composite surgical success at 1 year, which was defined as the absence of vaginal bulge symptoms, no additional retreatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality-of-life measures as well as perioperative complications, including mesh-related complications and hospitalization costs. Complications were categorized using the Clavien-Dindo system (with grade 1 indicating any deviation from the normal postoperative course but not requiring grade 2-4 interventions; grade 2, need for pharmacological treatment, blood transfusion, and/or total parenteral nutrition; grade 3, the need for surgical, endoscopic, and/or interventional radiological procedures; and grade 4, life threatening).ResultsAmong 336 female participants (mean [SD] age, 63.3 [5.9] years; all of Chinese ethnicity), 169 patients were randomized to the self-cut mesh group, and 167 were randomized to the mesh-kit group. Three patients were unavailable for follow-up after 1 year. In the intention-to-treat analysis, 162 women (95.9%) in the self-cut mesh group had outcomes that met the definition of surgical success; this result was noninferior to the surgical success rate observed in the mesh-kit group (146 women [87.4%]; risk difference, 8.5%; 95% CI, 2.2%-14.3%; P = .006). The frequency of Clavien-Dindo grade 1 to 3 perioperative complications was not significant between groups (12 of 166 women [7.2%] in the self-cut mesh group vs 20 of 161 women [12.4%] in the mesh-kit group; P = .14). Vaginal mesh exposure rates in women examined at 1 year were similar (4 women [2.4%] in the self-cut mesh group vs 8 women [4.8%] in the mesh-kit group; P = .23). Median (IQR) total hospitalization costs were $3663.00 ($3258.90-$4495.10) in the self-cut mesh group vs $6144.00 ($5434.90-$7160.20) in the mesh-kit group (P < .01), representing savings of $2481.00 (40.4%) with the use of self-cut mesh.Conclusions and relevanceIn this clinical trial, the composite surgical success rate of a self-cut mesh procedure was noninferior to that of a commercial mesh-kit procedure using the same titanium-coated polypropylene mesh and reduced hospitalization expenses by 40.4%. These findings suggest that the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe POP, particularly those in countries with low and middle income.Trial registrationClinicalTrials.gov identifier: NCT03283124.

Project description:Polypropylene meshes used in pelvic organ prolapse (POP) repair are hampered by complications. Most POP meshes are highly unstable after tensioning ex vivo, as evidenced by marked deformations (pore collapse and wrinkling) that result in altered structural properties and material burden. By intentionally introducing collapsed pores and wrinkles into a mesh that normally has open pores and remains relatively flat after implantation, we reproduce mesh complications in vivo. To do this, meshes were implanted onto the vagina of rhesus macaques in nondeformed (flat) vs deformed (pore collapse +/- wrinkles) configurations and placed on tension. Twelve weeks later, animals with deformed meshes had two complications, (1) mesh exposure through the vaginal epithelium, and (2) myofibroblast proliferation with fibrosis - a mechanism of pain. The overarching response to deformed mesh was vaginal thinning associated with accelerated apoptosis, reduced collagen content, increased proteolysis, deterioration of mechanical integrity, and loss of contractile function consistent with stress shielding - a precursor to mesh exposure. Regional differences were observed, however, with some areas demonstrating myofibroblast proliferation and matrix deposition. Variable mechanical cues imposed by deformed meshes likely induce these two disparate responses. Utilizing meshes associated with uniform stresses on the vagina by remaining flat with open pores after tensioning is critical to improving outcomes. STATEMENT OF SIGNIFICANCE: Pain and exposure are the two most reported complications associated with the use of polypropylene mesh in urogynecologic procedures. Most meshes have unstable geometries as evidenced by pore collapse and wrinkling after tensioning ex vivo, recapitulating what is observed in meshes excised from women with complications in vivo. We demonstrate that collapsed pores and wrinkling result in two distinct responses (1) mesh exposure associated with tissue degradation and atrophy and (2) myofibroblast proliferation and matrix deposition consistent with fibrosis, a tissue response associated with pain. In conclusion, mesh deformation leads to areas of tissue degradation and myofibroblast proliferation, the likely mechanisms of mesh exposure and pain, respectively. These data corroborate that mesh implantation in a flat configuration with open pores is a critical factor for reducing complications in mesh-augmented surgeries.

Project description:BackgroundTrans Vaginal Mesh (TVM) surgeries have been used to treat stress urine incontinency (SUI) and/or pelvic organ prolapse (POP). Systematic reviews of clinical studies of outcomes suggest that the procedures have benefited a majority of women, while noting that a small minority of women have experienced harms. To provide a more complete picture of outcomes, we conducted a systematic review of the qualitative literature to provide a comprehensive analysis of women's own accounts of their experience.MethodWe conducted a systematic review and thematic synthesis of the evidence from the international qualitative literature on women's experiences of and perspectives on TVM surgery for SUI and/or POP between 1996 and 2020. We retrieved 6587 papers from PubMed, Cochrane, CINAHL, PsycINFO, Scopus, and Sociological Abstracts. After application of inclusion and exclusion criteria and full-text review of eligible articles, five articles were included in our systematic review.ResultsFindings from included articles were organised under three main themes: women's everyday lives were transformed by TVM surgery; women's expectations of and approach to their future lives; and women's critiques of TVM surgery. The transformation of women's everyday lives included a struggle to obtain recognition and support for their injuries before and after corrective surgery, ongoing limitations on their social, professional and personal lives, and compounding medical and psychological trauma as a result. Women's approaches to their future lives changed because of this transformation; we identified five main approaches, four were ways of accommodating change, a fifth involved being unable to accommodate life changes. Women's critiques included that TVM surgeries were overused, consent processes were poor, and surgeons' definitions of success were deficient. Women expressed concerns about the safety of TVM products and future risks of further complications and discussed multiple system failures in the health care they received.ConclusionThis review suggests that discounting women's experiences has caused compound trauma and skewed the clinical evidence base; while harms occurred in a minority of women, we suggest they should be recognised as an ethically significant potential outcome. Approaches to TVM injury should attend to historical epistemic injustice and recognise women's agency.

Dataset Information

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

Background

Methods

Discussion

Trial registration

Publications

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets