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

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: Removal of vaginal endometriotic nodule; Procedure: longitudinal suture; Procedure: transverse suture

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • BO
    • Bologna, BO, Italy, 40138
      • Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Group A (vaginal technique); Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique	Procedure: Removal 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.
OTHER: Group B (laparoscopic technique); Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.	Procedure: Removal 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.; Procedure: longitudinal 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; Procedure: transverse 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2019
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (ACTUAL): November 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Deep infiltrating endometriosis; Vaginal endometriosis
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: Endo-Vag

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No