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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744143
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Mabrouk, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Endometriosis Procedure: longitudinal suture Procedure: transverse suture Procedure: Removal of vaginal endometriotic nodule Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
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.

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: 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

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.




Primary Outcome Measures :
  1. Operative time [ Time Frame: Intraoperative ]
    To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: Intraoperative ]
    Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.

  2. Evaluation of disease recurrence rate [ 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 ]
    Reappearance of vaginal nodule / rectum-vaginal septum in patients underwent different surgical techniques

  3. Evaluation of dyspareunia recurrence rate [ Time Frame: Up to 6 months after surgery ]
    Reappearance of dyspareunia in patients underwent different surgical techniques, assessed using a visual analog score, equal to or greater than 5

  4. Complication rate [ Time Frame: up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days ]
    Comparison of laparoscopic and vaginal approach concerning complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744143


Locations
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Italy
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, Italy, 40138
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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Responsible Party: Mohamed Mabrouk, Principal investigator, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03744143    
Other Study ID Numbers: Endo-Vag
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Mabrouk, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Vaginal endometriosis
Deep infiltrating endometriosis
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female