EndometriosisENDO-VAG-rNCT03744143
Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina
A study testing longitudinal suture, transverse suture and Removal of vaginal endometriotic nodule in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- longitudinal suture, transverse suture and Removal of vaginal endometriotic nodule
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesItaly
- Study dates
- 3 Jan 2019to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, 40138
Policlinico Universitario Agostino Gemelli
Roma, 00168
About this study
Official title: Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study
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.
Read the 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
- Being tested
- longitudinal suture, transverse suture, Removal of vaginal endometriotic nodule
- Keywords
- Vaginal endometriosis, Deep infiltrating endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
longitudinal sutureProcedure or surgery
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 sutureProcedure or surgery
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 noduleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (vaginal technique) | Other | Patients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique Receives: Procedure: Removal of vaginal endometriotic nodule |
| Group B (laparoscopic technique) | Other | Patients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture. Receives: Procedure: longitudinal suture; Procedure: transverse suture; Procedure: Removal of vaginal endometriotic nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time
Measured: Intraoperative
Secondary outcomes (4)
Complication rate
Comparison of laparoscopic and vaginal approach concerning intraoperative complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.
Measured: Intraoperative
Evaluation of disease recurrence rate
Reappearance of vaginal nodule / rectum-vaginal septum in patients underwent different surgical techniques
Measured: 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
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
Measured: Up to 6 months after surgery
Complication rate
Comparison of laparoscopic and vaginal approach concerning complication rate in patients affected by vaginal endometriosis, using Clavien-Dindo Classification.
Measured: up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start3 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mabrouk, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744143
- Sponsor's protocol ID
- Endo-Vag
- Acronym
- ENDO-VAG-r
- Status last verified
- Apr 2019
- First submitted
- 14 Nov 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study
- ClinicalTrials.gov ID
- NCT03744143
- Acronym / sponsor ID
- ENDO-VAG-r / Endo-Vag
- Conditions
- Endometriosis
- Keywords
- Vaginal endometriosis, Deep infiltrating endometriosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (vaginal technique) | Other | Procedure: Removal of vaginal endometriotic nodulePatients undergoing surgical removal of vaginal endometriotic nodule through vaginal technique |
| Group B (laparoscopic technique) | Other | Procedure: longitudinal suture, Procedure: transverse suture, Procedure: Removal of vaginal endometriotic nodulePatients undergoing surgical removal of vaginal endometriotic nodule through laparoscopic technique. Closure of the vagina with a transverse suture or a longitudinal suture. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- History of previous or ongoing neoplastic pathology
- Patients committed to hysterectomy
- Previous vaginal surgery
- Not complete eradicating surgery
- Vaginism-vulvodynia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| longitudinal sutureSurgical 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 or surgery | Group B (laparoscopic technique) |
| transverse sutureSurgical 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 or surgery | Group B (laparoscopic technique) |
| Removal of vaginal endometriotic noduleSurgical 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. | Procedure or surgery | Group A (vaginal technique), Group B (laparoscopic technique) |
Primary outcome
Operative time
Time frame: Intraoperative
To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time
4 secondary outcomes
Complication rate
Time frame: Intraoperative
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
Evaluation of dyspareunia recurrence rate
Time frame: Up to 6 months after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing longitudinal suture, transverse suture and Removal of vaginal endometriotic nodule in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.