Intraoperative Intraabdominal Ultrasound for Endometriosis

NCT05812937 | Unknown

• 1 other identifier: INTA-US-ENDO
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis; Endometriosis; Bowel; Ultrasound Therapy; Complications

Keywords

Endometriosis; Deep bowel endometriosis; Ultrasound; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Accuracy of IIUS compared to TVS regarding the colorectal endometriosis

  Compare the dimmensions of preop. TVS-diagnosed nodules with the intraop. IUS dimensions.

  At the moment of the surgery

Study Arms (1)

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.

Procedure: Intraabdominal ultrasound

Interventions

Intraabdominal ultrasound PROCEDURE

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.

Also known as: Laparoscopic visualization, Laparoscopic palpation, Direct palpation in case of a conventional segmental bowel resection with specimen extraction per minilaparotomy.

Women with suspicion of deep bowel endometriosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women affected by deep bowel endometriosis.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women affected by deep bowel endometriosis undergoing intraabdominal ultrasound.

You may qualify if:

• All the patients with suspicion of endometriosis who undergo surgery.

You may not qualify if:

• Patients under 18 years old;
• Patients who didn't sign the informed consent.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Albertinen Hospital

Hamburg, 22457, Germany

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Alin Constantin, M.D.

  Albertinen Hospital Hamburg

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D. Ph.D.

  University of Palermo

  STUDY DIRECTOR

• Andrea Etrusco, M.D.

  University of Palermo

  STUDY CHAIR

• Vito Chiantera, M.D. Ph.D.

  University of Palermo

  STUDY CHAIR

Central Study Contacts

Andrea Etrusco, M.D.

CONTACT

+39 388 1614022; etruscoandrea@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)