Transrectal Evaluation After Discoid Resection for Endometriosis Intestinal

NCT06761157 | Completed

• 1 other identifier: RESDISCO2021
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery

Conditions

Deep Endometriosis

Keywords

endometriosis; discoid resection; deep endometriosis; intestinal

Outcome Measures

Primary Outcomes (1)

• Success rate of rectosigmoidoscopic procedure in patients with deep endometriosis with bowel involvement undergoing segmental or discoid resection surgery

  Ratio of the number of successfully completed interventions to the total number of interventions performed using rectosigmoidoscopy. The success of the intervention is determined following qualitative evaluation of the anastomosis

  3 months after surgery

Secondary Outcomes (3)

• Incidence of intraoperative complications: rectorrhagia, leakage, mucosal crash, intussusception, anastomosis stenosis, intraperitoneal hemorrhage, conversion to laparotomy surgery

  During surgery

• Incidence of postoperative complications within the first three months post-segmental or discoid resection surgery among patients undergoing rectosigmoidoscopy and patients undergoing the same surgery without rectosigmoidoscopy

  3 months after surgery

• Operating time duration in patients undergoing discoid or segmental resection with or without the use of intraoperative rectosigmoidoscopy

  3 months after surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with deep endometriosis with suspected bowel involvement who will undergo segmental or discoid resection for the period of one year following the date of study approval

You may qualify if:

• Women between the ages of 18 and 50 years
• Women with diagnosis made by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected bowel involvement
• Women undergoing segmental or discoid resection for bowel endometriosis
• Obtaining informed consent

You may not qualify if:

• Patients who are candidates for elective laparotomic surgery
• Patients with concomitant inflammatory bowel disease known in history (inflammatory bowel syndrome)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Paolo Casadio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 7, 2025
• Study Start: March 21, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 29, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

IT (1)