None listed
Conditions
Brief summary
The aim is to create a more anatomical, safer and less invasive method for repairing uterine/apical prolapse. At present laparoscopic sacrocolpopexy is performed by attachment of the apex to the sacral promontory. This method is not anatomical and may cause difficulties with bladder and bowel evacuation post-operatively. The approach to the uterosacral likgamegts is by either side of the abdomen. Each USL is located. The USL is tensioned by pulling the uterus downwards.The USL is entered and a 5cm tunnel is made. Each anchor is inserted in turn and then tensioned via the TFS one-way system to elevate the prolapsed uterus or apex.
Interventions
The intervention is via standard laparoscopic equipment using two laterally sited canulas. There is one intervention, average duration one hour. The uterosacral ligaments (USL) are identified, held and penetrated with dissecting scissors to form a tunnel 5cm long inside the USL. The implant device consists of a purposely knitted polypropylene tape 7mm wide inserted into the base of an anchor 11mmx4,mm with 4 prongs. At the base of the anchor is a trapdoor-like arrangement through which the tap
The intervention is via standard laparoscopic equipment using two laterally sited canulas. There is one intervention, average duration one hour. The uterosacral ligaments (USL) are identified, held and penetrated with dissecting scissors to form a tunnel 5cm long inside the USL. The implant device consists of a purposely knitted polypropylene tape 7mm wide inserted into the base of an anchor 11mmx4,mm with 4 prongs. At the base of the anchor is a trapdoor-like arrangement through which the tape passes. This is a one-way system which allows the tape to be precisely tightened. This action also shortens the ligament. The tapes areinserted into each USL and the sling is tightened. The tape remains in situ permanently. A copy of all materials provided to the patients describing the lap intervention’’German language will be provided to ANZCTR in due course - - a surgeon from Feldkirk Austria will deliver the intervention. The surgeon has a 25 year surgical experience. - explanation of the intervention will be provided by the surgeon in a face to face pre-operative interview with each patient. - the intervention will be in the Feldkirk Hospital, Austria
Sponsors
Akademisches Lehrkrankenhaus Feldkirch
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All female patients with symptomatic prolapse
Exclusion criteria
Collateral illnesses sufficient to prevent safe surgery
Outcome results
None listed