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

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
longitudinal suture
transverse suture
Removal of vaginal endometriotic nodule
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Vaginal endometriosis, Deep infiltrating endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A (vaginal technique)

Group B (laparoscopic technique)

Arm Description

Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique

Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.

Outcomes

Primary Outcome Measures

Operative time
To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time

Secondary Outcome Measures

Complication rate
Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.
Evaluation of disease recurrence rate
Reappearance of vaginal nodule / rectum-vaginal septum in patients underwent different surgical techniques
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
Complication rate
Comparison of laparoscopic and vaginal approach concerning complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.

Full Information

First Posted
November 14, 2018
Last Updated
April 1, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03744143
Brief Title
Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina
Acronym
ENDO-VAG-r
Official Title
Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Vaginal endometriosis, Deep infiltrating endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (vaginal technique)
Arm Type
Other
Arm Description
Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique
Arm Title
Group B (laparoscopic technique)
Arm Type
Other
Arm Description
Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture.
Intervention Type
Procedure
Intervention Name(s)
longitudinal suture
Intervention Description
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
Intervention Name(s)
transverse suture
Intervention Description
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
Intervention Name(s)
Removal of vaginal endometriotic nodule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Operative time
Description
To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Complication rate
Description
Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.
Time Frame
Intraoperative
Title
Evaluation of disease recurrence rate
Description
Reappearance of vaginal nodule / rectum-vaginal septum in patients underwent different surgical techniques
Time Frame
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
Title
Evaluation of dyspareunia recurrence rate
Description
Reappearance of dyspareunia in patients underwent different surgical techniques, assessed using a visual analog score, equal to or greater than 5
Time Frame
Up to 6 months after surgery
Title
Complication rate
Description
Comparison of laparoscopic and vaginal approach concerning complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.
Time Frame
up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

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