ENDO-SHAVING: Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis

• Sponsor: Ospedale Policlinico San Martino (Other)
• Overall Status: Completed
• CT.gov ID: NCT04411004
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 32
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis, Rectum	Diagnostic Test: Transvaginal ultrasound; Behavioral: 5-point Likert scale

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Women who underwent shaving for rectal endometriosis	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

Outcome Measures

Primary Outcome Measures

1. Number of patients with rectal recurrence of endometriosis [3 months after the surgical approach]

   Evaluated by ultrasound

2. Number of patients with rectal recurrence of endometriosis [6 months after the surgical approach]

   Evaluated by ultrasound

Secondary Outcome Measures

1. Satisfaction of patients to the previous surgical treatment [3 months after the surgical approach]

   Evaluated by five-point Likert scale

2. Volume of nodules in patients with rectal recurrence of endometriosis [3 months after the surgical approach]

   Evaluated by ultrasound

3. Satisfaction of patients to the previous surgical treatment [6 months after the surgical approach]

   Evaluated by five-point Likert scale

4. Volume of nodules in patients with rectal recurrence of endometriosis [6 months after the surgical approach]

   Evaluated by ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale Policlinico San Martino	Genoa		Italy	16132

Sponsors and Collaborators

• Ospedale Policlinico San Martino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Fabio Barra, Principal Investigator, Ospedale Policlinico San Martino
• ClinicalTrials.gov Identifier: NCT04411004
• Other Study ID Numbers: ENDO-SHAVING
• First Posted: Jun 1, 2020
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Nov 18, 2020