Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

Completed

• Conditions: Endometriosis, Rectum
• Interventions: Diagnostic Test: Transvaginal ultrasound; Behavioral: 5-point Likert scale

• Registration Number: NCT04411004
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2019-11-30
• Study Completion: 2020-01-01
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-06-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum

Exclusion Criteria

• patients underwent previous bowel surgery (except appendectomy);
• patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women who underwent shaving for rectal endometriosis	5-point Likert scale	-
Women who underwent shaving for rectal endometriosis	Transvaginal ultrasound	-

Primary Outcome Measures

Name	Time	Method
Number of patients with rectal recurrence of endometriosis	6 months after the surgical approach	Evaluated by ultrasound

Secondary Outcome Measures

Name	Time	Method
Satisfaction of patients to the previous surgical treatment	6 months after the surgical approach	Evaluated by five-point Likert scale
Volume of nodules in patients with rectal recurrence of endometriosis	6 months after the surgical approach	Evaluated by ultrasound

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy