Overview
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.
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.
Eligibility
Inclusion criteria
- LSC simple hysterectomy,
- Neg. SS test if premenopausal
- >18j,
- Consent to participate in the study
- Understanding of the German language
Exclusion criteria
- Prolapse as indication for surgery
- Known or suspected non-compliance
- Additional incontinence procedures
- Patients with deep infiltrating endometriosis
- Irradiation pre- or postoperative
- Pregnancy and lactation.
- Transgender population
- Conversion from laparoscopy to laparotomy
- Inability to understand the study protocol