EndometriosisNCT05812937
Intraoperative Intraabdominal Ultrasound for Endometriosis
An observational study of Endometriosis and Endometriosis; Bowel, run by University of Palermo at 1 site in Germany.
Trial summary
The diagnosis of bowel endometriosis lesions is in most cases a combination of anamnesis, clinical exam, transvaginal ultrasound (and/or MRI and/or endorectal sonography) and laparoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Endometriosis; Bowel, Ultrasound Therapy; Complications
- What is being tested?
- Intraabdominal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2022to 1 Dec 2023
- 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: Women affected by deep bowel endometriosis undergoing intraabdominal ultrasound.
Who may be able to join
- All the patients with suspicion of endometriosis who undergo surgery.
Who cannot join
- Patients under 18 years old;
- Patients who didn't sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Albertinen Hospital
Hamburg, 22457
Andrea Etrusco, M.D., +39 388 1614022, etruscoandrea@gmail.com
About this study
Official title: The Diagnostic Value of the Intraoperative Intraabdominal Ultrasound for Deep Bowel Endometriosis
The diagnosis of bowel endometriosis lesions is in most cases a combination of anamnesis, clinical exam, transvaginal ultrasound (and/or MRI and/or endorectal sonography) and laparoscopy.
Both the transvaginal ultrasound as well as the MRI have showed a great accuracy with very good sensititivity and specificity regarding the imaging diagnosis of bowel endometriosis.
Read more
The conventional laparoscopy contributes to the diagnosis of bowel endometriosis by visualizing the nodules and palpating the deep endometriosis nodule using the instruments, therefor offering the surgeon a haptic feedback by grasping, pushing and rolling the bowel wall and the nodules. Horace Roman and Dan Martin showed that 25% of patients undergoing a conventional laparoscopic segmental bowel resection with a minilaparotomy hat palpable non-visualized endometriosis nodules. These nodules could be directly palpated with the hands because the bowel was exteriorized through the minilaparotomy. The direct palpation of the bowel offers of course a superior haptic feedback compared to the haptic feedback offered by the laparoscopic palpation using the instruments. However this was a direct palpation of only the oral part of the bowel. The aboral part of the bowel caudal to the staple line could not be evaluated by direct palpation. New surgical techniques for the segmental bowel resection with transvaginal/transanal NOSE(natural orifice specimen extraction) have been described in the last years. The novel techniques avoid the minilaparotomy and assure a 100% minimal invasive approach offering better esthetic outcomes.
However in such cases a direct palpation of the bowel wall using the hands in order to identify non- visualizable nodules is not possible as the bowel remains the whole time of the procedure inside of the abdomen. On the other side the robotic-assisted laparoscopy doesn't offer the surgeon a haptic feedback at all. In these cases the surgeon has to rely on the visual aspects of the lesions and therefor "touch" the lesions with his eyes - the visual information should replace the haptic feedback. So in the case of a robotic assisted laparoscopic segemental bowel resection with a NOSE it is not possible to palpate the bowel at all - neither with instruments, not with the hands. Other surgical techniques used to excise smaller colorectal nodules are the rectal shaving and the full thickness excision (disc excision) using a circular stapler. In these situations the surgeon has to rely exclusively on the visual information as well on the haptic feedback given by the conventional laparoscopic instruments. In more than 30% of the cases of full thickness rectal resection the resection the margins are infiltrated by the endometriosis nodules. All the above mentioned situations raise the question of the radicallity in terms of healthy resection margins and of multifocal lesions that cannot be visualized and/or palpated. In this study we are evaluating the diagnostic value of the intraoperative intraabdominal ultrasound for deep infiltrating colorectal endometriosis.
- Being tested
- Intraabdominal ultrasound
- Keywords
- Endometriosis, Deep bowel endometriosis, Ultrasound, laparoscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraabdominal ultrasoundProcedure or surgery
Also called Laparoscopic visualization, Laparoscopic palpation, Direct palpation in case of a conventional segmental bowel resection with specimen extraction per minilaparotomy.
To assess the diagnostic value of the intraoperative intrabaabdominal ultrasound (IIUS) for endometriosis patients as well as the predictive potential of changing the therapeutic strategy during the surgery based on the ultrasound findings.
| Study group | Role | What they receive |
|---|---|---|
| Women with suspicion of deep bowel endometriosis | Women with suspicion of deep bowel endometriosis undergoing intraoperative ultrasound to assess its diagnostic value for endometriosis patients as well as the predictive potential of changing the therapeutic strategy during the surgery based on the ultrasound findings. Receives: Procedure: Intraabdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of IIUS compared to TVS regarding the colorectal endometriosis
Compare the dimmensions of preop. TVS-diagnosed nodules with the intraop. IUS dimensions.
Measured: At the moment of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Dec 2023 (estimated)
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.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
- Investigators
- Alin Constantin, M.D., Principal investigator, Albertinen Hospital HamburgAntonio Simone Laganà, M.D. Ph.D., Study director, University of PalermoAndrea Etrusco, M.D., Study chair, University of PalermoVito Chiantera, M.D. Ph.D., Study chair, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812937
- Sponsor's protocol ID
- INTA-US-ENDO
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of the Intraoperative Intraabdominal Ultrasound for Deep Bowel Endometriosis
- ClinicalTrials.gov ID
- NCT05812937
- Acronym / sponsor ID
- INTA-US-ENDO
- Keywords
- Endometriosis, Deep bowel endometriosis, Ultrasound, laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
The diagnosis of bowel endometriosis lesions is in most cases a combination of anamnesis, clinical exam, transvaginal ultrasound (and/or MRI and/or endorectal sonography) and laparoscopy.
Both the transvaginal ultrasound as well as the MRI have showed a great accuracy with very good sensititivity and specificity regarding the imaging diagnosis of bowel endometriosis.
The conventional laparoscopy contributes to the diagnosis of bowel endometriosis by visualizing the nodules and palpating the deep endometriosis nodule using the instruments, therefor offering the surgeon a haptic feedback by grasping, pushing and rolling the bowel wall and the nodules. Horace Roman and Dan Martin showed that 25% of patients undergoing a conventional laparoscopic segmental bowel resection with a minilaparotomy hat palpable non-visualized endometriosis nodules. These nodules could be directly palpated with the hands because the bowel was exteriorized through the minilaparotomy. The direct palpation of the bowel offers of course a superior haptic feedback compared to the haptic feedback offered by the laparoscopic palpation using the instruments. However this was a direct palpation of only the oral part of the bowel. The aboral part of the bowel caudal to the staple line could not be evaluated by direct palpation. New surgical techniques for the segmental bowel resection with transvaginal/transanal NOSE(natural orifice specimen extraction) have been described in the last years. The novel techniques avoid the minilaparotomy and assure a 100% minimal invasive approach offering better esthetic outcomes.
However in such cases a direct palpation of the bowel wall using the hands in order to identify non- visualizable nodules is not possible as the bowel remains the whole time of the procedure inside of the abdomen. On the other side the robotic-assisted laparoscopy doesn't offer the surgeon a haptic feedback at all. In these cases the surgeon has to rely on the visual aspects of the lesions and therefor "touch" the lesions with his eyes - the visual information should replace the haptic feedback. So in the case of a robotic assisted laparoscopic segemental bowel resection with a NOSE it is not possible to palpate the bowel at all - neither with instruments, not with the hands. Other surgical techniques used to excise smaller colorectal nodules are the rectal shaving and the full thickness excision (disc excision) using a circular stapler. In these situations the surgeon has to rely exclusively on the visual information as well on the haptic feedback given by the conventional laparoscopic instruments. In more than 30% of the cases of full thickness rectal resection the resection the margins are infiltrated by the endometriosis nodules. All the above mentioned situations raise the question of the radicallity in terms of healthy resection margins and of multifocal lesions that cannot be visualized and/or palpated. In this study we are evaluating the diagnostic value of the intraoperative intraabdominal ultrasound for deep infiltrating colorectal endometriosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with suspicion of deep bowel endometriosis | – | Procedure: Intraabdominal ultrasoundWomen with suspicion of deep bowel endometriosis undergoing intraoperative ultrasound to assess its diagnostic value for endometriosis patients as well as the predictive potential of changing the therapeutic strategy during the surgery based on the ultrasound findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women affected by deep bowel endometriosis undergoing intraabdominal ultrasound.
Key inclusion criteria (1 listed)
- All the patients with suspicion of endometriosis who undergo surgery.
Key exclusion criteria (2 listed)
- Patients under 18 years old;
- Patients who didn't sign the informed consent.
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 |
|---|---|---|
| Intraabdominal ultrasoundAlso: Laparoscopic visualization, Laparoscopic palpation, Direct palpation in case of a conventional segmental bowel resection with specimen extraction per minilaparotomy.To assess the diagnostic value of the intraoperative intrabaabdominal ultrasound (IIUS) for endometriosis patients as well as the predictive potential of changing the therapeutic strategy during the surgery based on the ultrasound findings. | Procedure or surgery | Women with suspicion of deep bowel endometriosis |
Primary outcome
Accuracy of IIUS compared to TVS regarding the colorectal endometriosis
Time frame: At the moment of the surgery
Compare the dimmensions of preop. TVS-diagnosed nodules with the intraop. IUS dimensions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Alin Constantin, M.D. principal investigator
Albertinen Hospital Hamburg
Antonio Simone Laganà, M.D. Ph.D. study director
University of Palermo
Andrea Etrusco, M.D. study chair
University of Palermo
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 and Endometriosis; Bowel, run by University of Palermo at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Etrusco, M.D. (+39 388 1614022, etruscoandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of IIUS compared to TVS regarding the colorectal endometriosis (time frame: At the moment of the surgery). 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 14 Apr 2023.