Endometriosis
Conditions
Keywords
Vaginal endometriosis, Deep infiltrating endometriosis
Brief summary
Multicentric retrospective study about the comparison of two different techniques of vaginal breach suturing after eradication surgery for deep infiltrating endometriosis and the surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional outcomes.
Detailed description
Treatment of vaginal endometriosis can be successfully performed by vaginal or laparoscopic approach. The results of the surgical treatment confirm its validity with regard to the reduction of dyspareunia in the short to medium term but show less efficacy in the long follow-up. The long-term impact of surgery on sexual function may be influenced by multiple factors, such as recurrence of symptomatic or anatomical disease, preservation of autonomic nerve fibers responsible for the arousal and genital sensitivity and residual vaginal length. These factors are potentially dependent on the surgical approach performed to treat vaginal endometriosis. Particular importance as a surgical step assumes the closing phase of the vaginal defect that can be performed through a transverse or longitudinal suture. The longitudinal suture could guarantee, theoretically, a greater residual vaginal length and a better sexual function in the postoperative period than the vaginal closure by transversal suture, as demonstrated in previous studies about the suture techniques of vaginal cuff after hysterectomy. Up to date, there are no studies comparing surgical, clinical and functional outcomes of the vaginal suture neither the two surgical approaches (laparoscopic or vaginal) for vaginal endometriosis eradication.
Interventions
PROCEDURElongitudinal suture
Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a longitudinal suture
PROCEDUREtransverse suture
Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a transverse suture
PROCEDURERemoval of vaginal endometriotic nodule
Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, or vaginal technique, isolating the nodule through the vagina.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of vaginal endometriosis * Women undergoing surgical removal with complete endometriotic lesions involving the vagina * Informed consent for the processing of personal data for scientific purposes
Exclusion criteria
* History of previous or ongoing neoplastic pathology * Patients committed to hysterectomy * Previous vaginal surgery * Not complete eradicating surgery * Vaginism-vulvodynia * Psychiatric disorders * Genital prolapse * Surgical menopause or spontaneous or pharmacological menopause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Intraoperative | Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification. |
| Evaluation of disease recurrence rate | Up to 6 months after surgery; from date of surgery until the date of first clinical or trans-vaginal/abdominal ultrasound documented recurrence, assessed up to 6 months | Reappearance of vaginal nodule / rectum-vaginal septum in patients underwent different surgical techniques |
| Evaluation of dyspareunia recurrence rate | Up to 6 months after surgery | Reappearance of dyspareunia in patients underwent different surgical techniques, assessed using a visual analog score, equal to or greater than 5 |
Countries
Italy
Outcome results
None listed