Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Procedure: Removal of vaginal endometriotic nodule; Procedure: longitudinal suture; Procedure: transverse suture

• Registration Number: NCT03744143
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Study Start: 2019-01-03
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (vaginal technique)	Removal of vaginal endometriotic nodule	Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique
Group B (laparoscopic technique)	longitudinal suture	Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.
Group B (laparoscopic technique)	Removal of vaginal endometriotic nodule	Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.
Group B (laparoscopic technique)	transverse suture	Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.

Primary Outcome Measures

Name	Time	Method
Operative time	Intraoperative	To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time

Secondary Outcome Measures

Name	Time	Method
Complication rate	up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days	Comparison of laparoscopic and vaginal approach concerning complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.
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
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

Trial Locations

Locations (2)

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital; 🇮🇹 Bologna, BO, Italy