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

Observational Study Between Patients Undergoing Total Intracorporeal Anastomosis Or Extracorporeal Anastomosis After Segmental Resection For Deep Endometriosis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Endometriosis

Detailed Description

Surgery is the treatment of choice for deep endometriosis with bowel involvement and endometriosis nodules will be treated by segmental resection and subsequent anastomosis packing. Anastomosis packing with a totally intracorporeal approach may be a successful solution to reduce some of the complications after discoid or segmental resection with conventional laparotomic approach for extracorporeal anastomosis.

Setting up the colorectal anastomosis with a totally intracorporeal approach represents a surgical method that has been recently introduced but is already approved in terms of safety and reproducibility. However, experience with this technique is currently limited and there is no established consensus regarding patient suitability or data on longer-term outcomes. New studies are therefore needed to further validate the technique and to fully assess its long-term benefits resulting in increased quality of life for operated patients or to identify any associated complications.

The aim of the study is therefore to describe the impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis who underwent either a totally intracorporeal or extracorporeal procedure. In addition, the aim is to detect any differences in the duration of the operating time, compare the duration of the postoperative hospital stay and determine the success rate of the totally intracorporeal procedure

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com
• Study Contact Backup: Name: Stefano Ferla, MD; Email: stefano.ferla2@studio.unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com
    • Principal Investigator: Diego Raimondo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detect any differences in the duration of the total operating time in the two different treatments	Total operating time measured in minutes	During surgery
Duration of hospitalisation in the two different types of surgery	Measurement of hospitalisation time after 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	Number of successfully completed operations out of the total number of operations performed with a fully intracorporeal approach. The success of the intervention is established intraoperatively by performing hydropneumatic tests of the integrity of the anastomosis and during the operative course by assessing the possible occurrence of complications	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	Number of operations in which one (or more) of the intra-operative complications occurred out of the total number of operations performed with a totally intracorporeal approach	At 3 months after surgery
Incidence of post-operative complications in the two different surgical treatments	Number of operations in which one (or more) of the post-operative complications described above occurred out of the total number of operations performed	Within 3 months of surgery

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Diego Raimondo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Endometriosis; Anastomosis; Gynaecology; Segmental resection
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: ARISTOTLE23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No