Patients Undergoing Total Intracorporeal or Extracorporeal Anastomosis After Segmental Resection for Deep Endometriosis

NCT06826378 | Not Yet Recruiting

• 1 other identifier: ARISTOTLE23
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis undergoing either a totally intracorporeal or extracorporeal procedure

Conditions

Deep Endometriosis

Keywords

Endometriosis; Gynaecology; Surgery; Anastomosis; Segmental resection

Outcome Measures

Primary Outcomes (1)

• Impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis undergoing either a totally intracorporeal or extracorporeal procedure

  Evaluation by scoring the validated Low Anterior Resection Syndrome score questionnaire

  During the preoperative evaluation and at 3 months after surgery as part of the postoperative follow-up visit

Secondary Outcomes (5)

• Detect any differences in the duration of the total operating time in the two different treatments

  During surgery

• Duration of hospitalisation in the two different types of surgery

  From date of surgery until the discharge (0-30 days)

• Success rate of the totally intracorporeal procedure in patients with deep endometriosis with bowel involvement undergoing segmental resection surgery

  At 3 months after surgery

• Incidence of intra-operative complications (rectorrhagia, anastomotic dehiscence, intussusception, stenosis of the anastomosis, intraperitoneal haemorrhage, conversion to laparotomic surgery) and evaluate any differences in these between the two groups

  At 3 months after surgery

• Incidence of post-operative complications in the two different surgical treatments

  Within 3 months of surgery

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with deep endometriosis with suspected bowel involvement and intraoperative indication for segmental resection

You may qualify if:

• Women between 18 and 54 years of age
• Diagnosis, by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected intestinal involvement
• Intraoperative indication for segmental resection for intestinal endometriosis
• Obtaining informed consent for study participation and data processing

You may not qualify if:

• Patients with a known concomitant inflammatory bowel syndrome (inflammatory bowel syndrome)
• Patients undergoing emergency/emergency surgery

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

• Diego Raimondo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Raimondo, MD

CONTACT

+393290636618; die.raimondo@gmail.com

Stefano Ferla, MD

CONTACT

stefano.ferla2@studio.unibo.it

Study Design

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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: February 14, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-10

Locations

IT (1)