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Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

NCT ID: NCT04411004

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-01-01

Brief Summary

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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

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Conditions

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Endometriosis, Rectum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women who underwent shaving for rectal endometriosis

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis

5-point Likert scale

Intervention Type BEHAVIORAL

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

Interventions

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Transvaginal ultrasound

Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis

Intervention Type DIAGNOSTIC_TEST

5-point Likert scale

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Policlinico San Martino

OTHER

Sponsor Role lead

Responsible Party

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Fabio Barra

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale Policlinico San Martino

Genoa, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 31919838 (View on PubMed)

Other Identifiers

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ENDO-SHAVING

Identifier Type: -

Identifier Source: org_study_id