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Completed

NCT Number: NCT03744143

Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

longitudinal suture

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

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

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.

Primary outcomes

  1. Operative time

    Time frame: Intraoperative

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: ENDO-VAG-r

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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