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OpenTrials
Completed

NCT Number: NCT04411004

Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

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.

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Key information

Conditions

Endometriosis, Rectum Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transvaginal ultrasound

Diagnostic Test

Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis

5-point Likert scale

Behavioral

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

Primary outcomes

  1. Number of patients with rectal recurrence of endometriosis

    Time frame: 3 months after the surgical approach

    Evaluated by ultrasound

  2. Number of patients with rectal recurrence of endometriosis

    Time frame: 6 months after the surgical approach

    Evaluated by ultrasound

Secondary outcomes

  1. Satisfaction of patients to the previous surgical treatment

    Time frame: 3 months after the surgical approach

    Evaluated by five-point Likert scale

  2. Volume of nodules in patients with rectal recurrence of endometriosis

    Time frame: 3 months after the surgical approach

    Evaluated by ultrasound

  3. Satisfaction of patients to the previous surgical treatment

    Time frame: 6 months after the surgical approach

    Evaluated by five-point Likert scale

  4. Volume of nodules in patients with rectal recurrence of endometriosis

    Time frame: 6 months after the surgical approach

    Evaluated by ultrasound

Sponsors and collaborators

Lead sponsor

Ospedale Policlinico San Martino

Other

Registry information

Official study title

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

Acronym: ENDO-SHAVING

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 1, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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