Prolapse Pelvic
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREStandard cuff closure
Standard laparoscopic barbed suture of the vaginal cuff
PROCEDUREMcCall suture
Laparoscopic suture including the uterosacral ligaments and the peritoneum
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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. * Conversion from laparoscopy to laparotomy * Inability to understand the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm. | 5 years | Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years. Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function | 5 years | Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score |
Countries
Switzerland
Contacts
CONTACTDiana Höhn, MD
STUDY_DIRECTORMichel D Mueller, Prof.
Department of Gynaecology, University Hospital, Berne
Outcome results
None listed