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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04411004
Other study ID # ENDO-SHAVING
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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