Gynecologic Disorders, Pelvic Organ Prolapse, Surgery
Conditions
Keywords
pelvic organ prolapse, urogynecologic surgery, learning curve, bipolar vessels sealing
Brief summary
Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.
Detailed description
This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics. Patients will be randomized 1:1 in two groups: 1. Study group: bipolar coagulation technique 2. Comparison group: reabsorbable stitches The primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration. The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.
Interventions
PROCEDUREvaginal hysterectomy by bipolar vessels sealing
The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument
PROCEDUREvaginal hysterectomy by traditional technique
The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Patients will be randomized 1:1 in two groups: 1. Study group: bipolar coagulation technique 2. Comparison group: reabsorbable stitches
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women aged \>18 years * Genital prolapse \> II degree in accordance with the POP-Q System eligible for vaginal hysterectomy * Understanding and signing of informed consent for surgical procedure
Exclusion criteria
* Need for simultaneous bilateral adnexectomy * Previous cesarian section * Patients with abdominal laparoscopic or laparotomy history * Patients with malignant pathology and/or adnexal pathology * Confirmed or presumed pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Learning curve comparison | immediate post operative time | The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of the two different techniques of vaginal hysterectomy. | 3 days after the surgical procedure | Effectiveness will be assessed in terms of short-term outcomes such as: Intraoperative complications post-operative pain inpatient time Post-operative urinary infections vaginal infections, postoperative collected hematomas |
Countries
Italy
Contacts
Primary ContactArianna Casiraghi, MD
Backup ContactStefano Salvatore, MD
Outcome results
None listed