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NCT Number: NCT06826378

Patients Undergoing Total Intracorporeal 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

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Key information

Age range

18 year–54 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location contact

Diego Raimondo, MD

CONTACT

[email protected]

+393290636618

Diego Raimondo, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

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

    Evaluation by scoring the validated Low Anterior Resection Syndrome score questionnaire

Secondary outcomes

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

    Time frame: During surgery

    Total operating time measured in minutes

  2. Duration of hospitalisation in the two different types of surgery

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

    Measurement of hospitalisation time after surgery

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

    Time frame: At 3 months after 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

  4. 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

    Time frame: At 3 months after surgery

    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

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

    Time frame: Within 3 months of surgery

    Number of operations in which one (or more) of the post-operative complications described above occurred out of the total number of operations performed

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Raimondo, MD

CONTACT

[email protected]

+393290636618

Stefano Ferla, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

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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