Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina (ENDO-VAG-r)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Endometriosis

Treatments: Procedure: longitudinal suture; Procedure: Removal of vaginal endometriotic nodule; Procedure: transverse suture

Study type: Interventional

Funder types: Other

Identifiers

NCT03744143

Endo-Vag

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Group A (vaginal technique)

Other group

Description:

Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique

Treatment:

Procedure: Removal of vaginal endometriotic nodule

Group B (laparoscopic technique)

Other group

Description:

Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.

Treatment:

Procedure: Removal of vaginal endometriotic nodule

Procedure: longitudinal suture

Procedure: transverse suture