Laparoscopic verus vaginal mesh surgery in the management of post-hysterectomy vaginal vault prolapse

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Purpose and Background of this research During your last appointment in Dr Maher’s clinic you have decided to undergo an operation to correct genital prolapse with or without stress incontinence. We currently conduct the above study to compare two different approaches of prolapse repairs, the laparoscopic = “key-hole surgery” and the vaginal route. Both routes have been shown to be safe and efficient with similar success rates but they have never been compared in a randomised controlled trial. Success, complications and risks of the operations are individually different depending on previous operations for example. These issues will be discussed with you prior to the operation. You are invited to participate in this research project because we think that your prolapse can be repaired by both routes the key-hole surgery or the vaginal repair. The results of this repair will help future patients and doctors to decide on the best management of prolapse. 3. Procedures If you decide to take part in this study, the computer will allocate you by chance to undergo key-hole or vaginal surgery. There will be no extra tests than those required for any of the surgery. We will ask you to complete three different questionnaires regarding your symptoms and effect on your quality of life before and six months after the surgery. After surgery, we will review the outcome at a routine six-weeks, six-months and one-year appointment or more often as required. 4. Possible benefits Participation in the study is voluntary. There are no direct benefits for you from participating. Future patients with similar problems might benefit from the study results when deciding on the most appropriate route of prolapse and stress incontinence repair. You will not be paid for your participation in this project. 5. Possible risks Your decision to take part or not does not in any way affect your future treatment. Participating in this study does not involve any additional risk than the surgery you had already decided to undergo for the treatment of your problems. The benefits, risks and complications of the different procedures are explained in specific surgical information sheets that will be provided to you before you decide to take part in this project. All procedures, risks and complications will be discussed with you prior to the surgery. 6. Alternative to participation The alternative to surgery is conservative management of your prolapse with or without stress incontinence which we will have offered to you before considering surgery. If you do not feel comfortable with one or another part of the surgery, you may withdraw from the study at any time before the surgery starts without any explanation. 7. Privacy and Confidentiality Your confidentiality is ensured by using your hospital number only. The results of this study will be published in a way that prevents any identification. The research data will be kept in a safe way for at least seven years. Only the above named researchers and a research nurse will have access to the collected data. Any information obtained in connection with this project and that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. In any publication, information will be provided in such a way that you cannot be identified.

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