Health TrialsbyHealthPanel

Intraoperative Ultrasound in Bowel Deep Endometriosis

ConditionDeep Infiltrating Endometriosis With or Without Bowel Involvement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFundacion Dexeus

About this trial

This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preoperative sonographic and/or MRI findings suggestive of bowel DIE (uterosacral ligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginal septum, rectum, and/or sigmoid colon).

Scheduled for surgical treatment (laparoscopy or robot-assisted laparoscopy).

Planned postoperative follow-up for at least 12 months.

Written informed consent provided before surgery.

Disqualifiers

Planned surgery for diagnostic purposes only.

Pregnancy at the time of enrollment.

Poor understanding of Spanish or English.

Trial population

Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis

    Procedure/Surgery

    Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: posterior compartment deep infiltrating endometriosis1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of intraoperative ultrasound

o The proportion of patients in whom intraoperative ultrasound techniques can successfully identify rectal or rectosigmoid junction deep infiltrating endometriosis nodules during surgery.

Time frame
Day of surgery
2

Accuracy of intraoperative ultrasound

o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.

Time frame
Day of surgery

Secondary outcomes

1

Impact on Surgical Decision-Making

o Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings.

Time frame
Day of surgery
2

Postoperative Pain and Function

Improvement in pain symptoms and quality of life

Time frame
at 3-months, 6-months and 12-months follow-up
3

Complication Rates

o Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III).

Time frame
From day of surgery to 7 days later

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Dexeus

Lead sponsor

Source ClinicalTrials.gov
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