Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

NCT ID: NCT03744143

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2019-03-01

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.

Conditions

Endometriosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (vaginal technique)

Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique

Group Type: OTHER

Removal of vaginal endometriotic nodule

Intervention Type: PROCEDURE

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.

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.

Group Type: OTHER

longitudinal suture

Intervention Type: PROCEDURE

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

transverse suture

Intervention Type: PROCEDURE

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

Removal of vaginal endometriotic nodule

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mabrouk

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Bologna, BO, Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Countries

Italy

Other Identifiers

Endo-Vag

Identifier Type: -

Identifier Source: org_study_id