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Intraoperative Ultrasound in Rectal Shaving for Deep Infiltrating Endometriosis: Evaluation of Residual Disease, Bowel Wall Thickness, and Clinical Outcomes
Sponsor study identifier
observational
57
0 countries
N/A
Study Start
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 7, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Deep infiltrating endometriosis (DIE) involving the bowel, particularly the rectosigmoid region, is associated with significant gastrointestinal symptoms and impaired quality of life. Rectal shaving is a conservative surgical technique aimed at removing endometriotic lesions while preserving bowel integrity; however, it may result in residual disease or excessive thinning of the bowel wall, potentially leading to recurrence or complications. Intraoperative ultrasound (IOUS) allows real-time assessment of residual nodule thickness and bowel wall thickness after shaving. This prospective observational study aims to evaluate the relationship between intraoperative ultrasound measurements and postoperative clinical outcomes, including gastrointestinal symptoms and quality of life. The study also seeks to identify ultrasound cut-off values that may guide intraoperative surgical decision-making and optimize the balance between radicality and safety.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 8, 2026
Actual (reported)April 7, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Gastrointestinal Symptoms and Quality of Life Scores
Change in gastrointestinal symptom severity and quality of life (PAC-SYM and PAC-QOL scores) from baseline to 12 months, stratified by depth of muscular infiltration (1-6 mm, 7-12 mm, 13-20 mm)
12 months
Association Between Residual Bowel Wall Thickness and Surgical Complications
12 months
Identification of Predictive Ultrasound Cut-off Values
12 months
The study population consists of women of reproductive age diagnosed with deep infiltrating endometriosis involving the rectum or sigmoid colon, with muscularis propria infiltration between 1 and 20 mm as assessed by expert preoperative transvaginal ultrasound. Eligible patients are those scheduled to undergo laparoscopic rectal shaving as part of standard clinical care at a tertiary referral center for endometriosis. All participants provide written informed consent prior to enrollment.
Giorgia Gaia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
April 1, 2026
First Posted
April 8, 2026
Study Start
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 7, 2027
EstimatedHistological Evaluation of Dual-wavelength Diode Laser Ablation of Ovarian Endometrioma
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 8, 2026
Record last verified: 2026-03
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