Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: longitudinal suture
* Procedure: transverse suture
* Procedure: Removal of vaginal endometriotic nodule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A (vaginal technique)<br>Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique | Procedure: Removal of vaginal endometriotic nodule<br>* 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.<br>|
| Other: Group B (laparoscopic technique)<br>Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture. | Procedure: longitudinal suture<br>* 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<br>Procedure: transverse suture<br>* 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<br>Procedure: Removal of vaginal endometriotic nodule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification. | Intraoperative | 
| Evaluation of disease recurrence rate | Reappearance of vaginal nodule / rectum-vaginal septum in patients underwent different surgical techniques | 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 | 
| Evaluation of dyspareunia recurrence rate | Reappearance of dyspareunia in patients underwent different surgical techniques, assessed using a visual analog score, equal to or greater than 5 | Up to 6 months after surgery | 
| Complication rate | Comparison of laparoscopic and vaginal approach concerning complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification. | up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal endometriosis, Deep infiltrating endometriosis