Endometriosis, RectumENDO-SHAVINGNCT04411004
Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis
An observational study of Endometriosis, Rectum, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Rectum
- What is being tested?
- Transvaginal ultrasound and 5-point Likert scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2017to 1 Jan 2020
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent shaving of rectal endometriosis
Who may be able to join
- patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum
Who cannot join
- patients underwent previous bowel surgery (except appendectomy);
- patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum
When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Theoretically, compared with segmental bowel resection, the shaving technique may expose the patients to a higher risk of persistence of intestinal endometriosis. The objective of this ultrasonographic study was to assess the risk of rectal endometriosis persistence following laparoscopic shaving of rectovaginal nodules.
- Conditions
- Endometriosis, Rectum
- Being tested
- Transvaginal ultrasound, 5-point Likert scale
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDiagnostic test
Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis
5-point Likert scaleBehavioural
Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Women who underwent shaving for rectal endometriosis | Not described Receives: Diagnostic Test: Transvaginal ultrasound; Behavioral: 5-point Likert scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with rectal recurrence of endometriosis
Evaluated by ultrasound
Measured: 3 months after the surgical approach
Number of patients with rectal recurrence of endometriosis
Evaluated by ultrasound
Measured: 6 months after the surgical approach
Secondary outcomes (4)
Satisfaction of patients to the previous surgical treatment
Evaluated by five-point Likert scale
Measured: 3 months after the surgical approach
Volume of nodules in patients with rectal recurrence of endometriosis
Evaluated by ultrasound
Measured: 3 months after the surgical approach
Satisfaction of patients to the previous surgical treatment
Evaluated by five-point Likert scale
Measured: 6 months after the surgical approach
Volume of nodules in patients with rectal recurrence of endometriosis
Evaluated by ultrasound
Measured: 6 months after the surgical approach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 May 2017
- Primary completion30 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometriosis, RectumStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Barra, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411004
- Sponsor's protocol ID
- ENDO-SHAVING
- Acronym
- ENDO-SHAVING
- Status last verified
- Nov 2020
- First submitted
- 19 May 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.
PubMed 31919838
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum
- ClinicalTrials.gov ID
- NCT04411004
- Acronym / sponsor ID
- ENDO-SHAVING / ENDO-SHAVING
- Conditions
- Endometriosis, Rectum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 1 Jun 2020 (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.
When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Theoretically, compared with segmental bowel resection, the shaving technique may expose the patients to a higher risk of persistence of intestinal endometriosis. The objective of this ultrasonographic study was to assess the risk of rectal endometriosis persistence following laparoscopic shaving of rectovaginal nodules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who underwent shaving for rectal endometriosis | – | Diagnostic Test: Transvaginal ultrasound, Behavioral: 5-point Likert scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent shaving of rectal endometriosis
Key inclusion criteria (1 listed)
- patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum
Key exclusion criteria (2 listed)
- patients underwent previous bowel surgery (except appendectomy);
- patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)
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 |
|---|---|---|
| Transvaginal ultrasoundTransvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis | Diagnostic test | Women who underwent shaving for rectal endometriosis |
| 5-point Likert scaleSubjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis | Behavioural | Women who underwent shaving for rectal endometriosis |
Primary outcome
Number of patients with rectal recurrence of endometriosis
Time frame: 3 months after the surgical approach
Evaluated by ultrasound
Number of patients with rectal recurrence of endometriosis
Time frame: 6 months after the surgical approach
Evaluated by ultrasound
4 secondary outcomes
Satisfaction of patients to the previous surgical treatment
Time frame: 3 months after the surgical approach
Volume of nodules in patients with rectal recurrence of endometriosis
Time frame: 3 months after the surgical approach
Satisfaction of patients to the previous surgical treatment
Time frame: 6 months after the surgical approach
Volume of nodules in patients with rectal recurrence of endometriosis
Time frame: 6 months after the surgical approach
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 18 Nov 2020.
- Background: PubMed 31919838Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, Rectum, run by Ospedale Policlinico San Martino at 1 site 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 1 inclusion and 2 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patients with rectal recurrence of endometriosis (time frame: 3 months after the surgical approach). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411004, which also lists 1 linked publication.
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 18 Nov 2020.