Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

NCT04411004 | Completed

• 1 other identifier: ENDO-SHAVING
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis, Rectum

Outcome Measures

Primary Outcomes (2)

• Number of patients with rectal recurrence of endometriosis

  Evaluated by ultrasound

  3 months after the surgical approach

• Number of patients with rectal recurrence of endometriosis

  Evaluated by ultrasound

  6 months after the surgical approach

Secondary Outcomes (4)

• Satisfaction of patients to the previous surgical treatment

  3 months after the surgical approach

• Volume of nodules in patients with rectal recurrence of endometriosis

  3 months after the surgical approach

• Satisfaction of patients to the previous surgical treatment

  6 months after the surgical approach

• Volume of nodules in patients with rectal recurrence of endometriosis

  6 months after the surgical approach

Study Arms (1)

Women who underwent shaving for rectal endometriosis

Diagnostic Test: Transvaginal ultrasound; Behavioral: 5-point Likert scale

Interventions

Transvaginal ultrasound DIAGNOSTIC_TEST

Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis

Women who underwent shaving for rectal endometriosis

5-point Likert scale BEHAVIORAL

Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis

Women who underwent shaving for rectal endometriosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent shaving of rectal endometriosis

You may qualify if:

• patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Location

Related Publications (1)

• Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.

  PMID: 31919838 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 1, 2020
• Study Start: May 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: January 1, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

IT (1)