Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

Endometriosis, Rectum Clinical Trial

— ENDO-SHAVING  

Official title:

Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411004
• Other study ID #: ENDO-SHAVING
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2020
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis, Rectum

Intervention

Diagnostic Test:
• Transvaginal ultrasound
Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis

Behavioral:
• 5-point Likert scale
Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with rectal recurrence of endometriosis	Evaluated by ultrasound	3 months after the surgical approach
Primary	Number of patients with rectal recurrence of endometriosis	Evaluated by ultrasound	6 months after the surgical approach
Secondary	Satisfaction of patients to the previous surgical treatment	Evaluated by five-point Likert scale	3 months after the surgical approach
Secondary	Volume of nodules in patients with rectal recurrence of endometriosis	Evaluated by ultrasound	3 months after the surgical approach
Secondary	Satisfaction of patients to the previous surgical treatment	Evaluated by five-point Likert scale	6 months after the surgical approach
Secondary	Volume of nodules in patients with rectal recurrence of endometriosis	Evaluated by ultrasound	6 months after the surgical approach