Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

Endometriosis Clinical Trial

— ENDO-VAG-r  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744143
• Other study ID #: Endo-Vag
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
Italy	Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital	Bologna	BO
Italy	Policlinico Universitario Agostino Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time	Intraoperative
Secondary	Complication rate	Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.	Intraoperative
Secondary	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
Secondary	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
Secondary	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