Clinical trial NCT03744143: Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina
Official title: Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Vaginal endometriosis
Deep infiltrating endometriosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: Intraoperative
Secondary outcomes:
measure: Complication rate
timeFrame: Intraoperative
measure: Evaluation of disease recurrence rate
timeFrame: 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
measure: Evaluation of dyspareunia recurrence rate
timeFrame: Up to 6 months after surgery
measure: Complication rate
timeFrame: up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
state: BO
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
Study officials:
References: