Prophylactic Laparoscopic Suspension After McCall
Prolapse Pelvic Clinical Trial
Official title: Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
Clinical Trial Summary
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor
and especially no long-term data exists for a standardized laparoscopic approach, but the few
studies could show good anatomic results.
The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual
vaginal cuff closure in a randomized controlled double-blinded trial.
Clinical Trial Description
182 patients will be enrolled in the study. We randomize the patient before surgery and
information about the procedure will be transmitted to the theatre in a sealed envelope. The
surgeon will open the envelope just before surgery. For randomization we apply a 1:1
allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall
sutures). The McCall suture is standardized: we apply a purse-string suture including both
USL and the peritoneum.
Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
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Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
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