Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP
- Conditions
- Pelvic Organ ProlapseRectal ProlapseIntestinal Obstruction
- Interventions
- Device: interdisciplinary mesh sacro colpopexy with resection rectopexy
- Registration Number
- NCT06245577
- Lead Sponsor
- Evangelisches Klinikum Köln Weyertal gGmbH
- Brief Summary
The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture. Subsequently, a multicentre, randomized intervention study is planned to confirm the results and evaluate the long-term outcomes.
- Detailed Description
Obstructive defecation syndrome (ODS) is a disordered defecation process due to a protrusion and telescope-like invagination of the lower rectum (rectocele, intussusception). This is often accompanied by a dolichocolon and chronic constipation. The feeling of an obstruction in the pelvic floor leads to forced pushing behavior in order to empty the rectum. Manual manipulation (transrectal or transvaginal) may also be necessary. Repeated and unsuccessful emptying attempts are often associated with the feeling of incomplete bowel evacuation. The patients affected are deeply frustrated and their thoughts revolve around the evacuation process. Their quality of life is considerably impaired. Around 10-25% of the population are affected The clinical picture predominantly affects women and is often associated with pelvic organ prolapse (POP). In these cases, the POP is the result of pathological pushing behavior for defecation. In addition, there may be other individual etiologies, such as post-vaginal delivery, connective tissue diseases, physiological lowering of the pelvic floor with age and surgical interventions in the pelvic area, which worsen the condition\]. Up to 60% of the female population suffers from POP, and a third of these suffer from bowel dysfunction in the form of constipation (33%) and/or ODS (26%).
Conservative treatment options such as dietary changes, adequate fluid intake, laxative medication, physical exercise, pelvic floor training, pelvic floor biofeedback therapy with or without electro stimulation and pessary treatment are limited and do not achieve the desired long-term effect Surgery is the alternative in these cases with the aim of restoring the anatomy More than 12% of all women have to undergo surgery in the course of their lives For some time now, an interdisciplinary surgical approach has been possible in which all affected compartments can be treated in a single procedure. The current results demonstrate the safety of this approach and represent a promising option for affected patients.
At the same time, the US Food and Drug Administration (FDA) issued a warning in 2008 against the use of mesh implants in reconstructive pelvic floor surgery, as serious long-term complications have sometimes been observed. With synthetic mesh, the mesh remains permanently in close proximity to the other pelvic organs and can lead to mesh infection, erosion and migration over time. These conditions can have serious consequences for individual patients and in some cases even lead to a permanent stoma. The use of synthetic mesh is restricted in the United States for both transvaginal and abdominal POP surgery due to long-term complications (erosion, migration and chronic infection of the mesh). In Germany, the use of synthetic meshes is also highly controversial and is restricted to use in POP with vaginal reconstruction for recurrent procedures.
The information about serious adverse events associated with the use of synthetic mesh in reconstructive pelvic floor surgery has unsettled many patients. Women of a younger age in particular have a long life expectancy and an increased risk of adverse events due to the synthetic mesh material. Some of them still want to become pregnant after the operation. At the same time, the disease - even if it is not life-threatening - has an enormous impact on the individual's quality of life, and most of those affected still need surgery.
For these patients, the use of a biological mesh appears to be a sensible alternative. The biological material carries a low risk of mesh infection, as the material allows cellular infiltration and is degraded within 12 to 18 months. There is no risk of arrosion or migration of the biological mesh due to the degradation of the material. However, the reconstruction may lose its stability after degradation of the mesh, which in some cases could lead to recurrence of the depression. This in turn could reduce the long-term success of the intervention. This is possibly the reason why the biological mesh is currently not recommended for SCP in the German guideline for pelvic floor surgery . However, there is little scientific evidence and the recommendation in the guideline is based on only two publications on this topic. At the same time, biological meshes have been used for ventral mesh rectopexy for some time with promising results. No mesh-related complications have yet been observed. As a result, the Biodesign rectopexy graft received FDA approval in the USA and CE marking in Germany in accordance with the Medical Device Directive.
The data on the use of biological mesh for ventral mesh rectopexy and the wishes of the patients concerned have encouraged us to re-evaluate the issue. We are convinced that the bionet leads to the formation of scar tissue during apical fixation of the internal genitalia by means of sacrocolpopexy and in combination with resection rectopexy, which fixes the pelvic organs in place even after resorption of the mesh and prevents recurrence of descensus.
In the study, the mesh is placed in the same space (between the rectum and vagina) as for the treatment of rectal prolapse/intussusception in mesh rectopexy. With this defined and standardized technique, Cook Biotech evaluates the mesh application in this pilot study as "intended use" of its approved product. Furthermore, the Ethics Committee of the University of Cologne confirms that the biological mesh is used for this pilot study within the scope of its intended purpose and in accordance with the safety and quality requirements of the European Medical Device Regulation (MDR). Thus, the study falls under §47 (3) of the MDR.
The planned pilot study is necessary in view of the currently still negative recommendation of the German guideline, the limited data on the use of biological mesh in laparoscopic SCP and the risks associated with the use of synthetic mesh, especially in younger women, in order to find an alternative to the synthetic mesh material.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- clinical diagnosis of obstructed defection syndrome
- clinical diagnosis of pelvic organ prolapse pelvic organ prolapse
- must be suitable for surgery
- allergy to the components of the mesh
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Synthetic mesh interdisciplinary mesh sacro colpopexy with resection rectopexy DynaMesh (TM) VASA Mesh used in the mesh sacropexy of the middle pelvic organ compartment (vagina, cervix, or uterus); the mesh fixes the middle pelvic organ compartment to the promontory Biomesh interdisciplinary mesh sacro colpopexy with resection rectopexy Biodesign (TM) Rectopexy Graft Mesh used in the mesh sacropexy of the middle pelvic organ compartment (vagina, cervix, or uterus); the mesh fixes the middle pelvic organ compartment to the promontory
- Primary Outcome Measures
Name Time Method safety of the experimental internvention as measured by surgical outcome 12 months Morbidity and mortality according to the Clavien-Dindo Classification (CDC) at 12 months after surgery (maximum value)
- Secondary Outcome Measures
Name Time Method Rectal Toxicity Score for bowel dysfunction 12 months Improvement in medical condition as measured rectal toxicity score for bowel dysfunction, min/max points 0-30 point, more points indicate more severe bowel dysfunction; a reduction after intervention indicates improvement/deterioration (-3 =better, - 6 = much better; +3=worse, +6=much worse)
Altomare Score for Obstruct4ed defecation syndrome (ODS) 12 months Improvement in medical condition as measured Altomare score for ODS, min/max points 0-30 point, more points indicate more severe ODS symptoms; a reduction after intervention indicatesmprovement/deterioration (-3 =better, - 6 = much better; +3=worse, +6=much worse)
Pelvic organ prolapse Quantification (POP Q) 12 months Measurement of clinical pelvic organ prolapse by the above score. min/max 0-4, more points are more symptoms. Improvement of the POP-Q is -1= good; -2 = very good; +1 =worse, +2=much worse.
Wexner Incontinence Score for fecal incontinence 12 months Improvement in medical condition as measured with Wexner Incontinence Score for fecal incontinence, min/max points 0-20 point, more points indicate more severe incontinence symptoms; a reduction after intervention indicates mprovement/deterioration (-3 =better, - 6 = much better; +3=worse, +6=much worse)
Trial Locations
- Locations (1)
Evangelisches Klinikum Koeln Weyertal
🇩🇪Cologne, Northrhine Westphalia, Germany