A Phase 2/3 interventional study of reduced mesh implants in Post Operative Pain and Complication of Surgical Procedure, sponsored by Western Galilee Hospital-Nahariya. Completed at 2 sites in Israel. Open to female participants aged 35 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-18.
Sponsored by Western Galilee Hospital-Nahariya · Phase 2/3, Interventional, and Treatment
Pelvic organ prolapse is an herniation process, needing a mesh reconstruction for long lasting therapeutic effect. Yet, mesh implants were reported to be related to severe adverse effects. This study looks at the potential benefit of mesh size reduction regarding avoiding operative complications.
Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma.
It is evident that pelvic organ prolapse (POP) occurs when the supporting pelvic floor becomes weakened or stretched, usually caused by childbirth, leading to descent of the pelvic organs to the vagina and beyond. This contributes to the impairment of pelvic organ function and a deterioration of patient quality of life. POP is estimated to severely affect approximately 11% of the female population.
Symptomatic POP patients might benefit from conservative management, such as the use of physiotherapy or vaginal pessaries. However, advanced POP necessitates surgical reconstruction. This might be achieved by the abdominal approach by an open operation or by laparoscopy, or by the vaginal approach. Synthetic permanent or absorbable meshes or biological grafts, or any synthesis of these might be used for reinforcement of the weakened pelvic floor structures that led to POP.
The need for reinforcement of the weakened fascia for achieving a long lasting cure of herniation processes is un-questionable. Given that the underlying pathology leading to POP is actually just a hernia of the pelvic floor, one must admit that the very same surgical principles used for any hernia repair are applicable for POP.
Most of the adverse effects are related to excessive implanted mesh mass. Thus, our goal with this study is to look at the issue of reducing the mesh size, surface area and the total mesh mass, assuming that the less quantity of left over implant the less mesh related complication will occur. The narrative for that is the notion that the natural pelvic floor connective tissue architecture is ligamentary and not "sheath like", while available pre-cut meshes are much too wide spread. This study concept is that reducing the mesh surface will lead to reduction with the mesh related complication. Given that the mesh implant size will be reduced, so will also be the wide of the extent of preliminary dissection, necessary for proper mesh placement. Thus, the dissection related adverse effects are expected to reduce as well.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
-Patients with advanced pelvic organ prolapse
Exclusion Criteria:
Patients treated with reduced mesh implants for POP reconstruction
Other: reduced mesh implants
mesh for pelvic floor reinforcement
Intra-operative and post operative adverse effects
Vaginal and pelvic pain upon VAS, vaginal mesh exposure, infections.
Time frame: One year post operative
Efficacy
Pelvic organ prolapse reconstruction upon the International Continence Society Pelvic Organ Prolapse Quantification System measurements
Time frame: One year
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Western Galilee Hospital-Nahariya