Clinical trial NCT06826378: Patients Undergoing Total Intracorporeal or Extracorporeal Anastomosis After Segmental Resection for Deep Endometriosis
Official title: Observational Study Between Patients Undergoing Total Intracorporeal Anastomosis Or Extracorporeal Anastomosis After Segmental Resection For Deep Endometriosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Deep Endometriosis
Keywords: Endometriosis
Gynaecology
Surgery
Anastomosis
Segmental resection
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with deep endometriosis with suspected bowel involvement and intraoperative indication for segmental resection

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

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: During the preoperative evaluation and at 3 months after surgery as part of the postoperative follow-up visit
Secondary outcomes:
measure: Detect any differences in the duration of the total operating time in the two different treatments
timeFrame: During surgery
measure: Duration of hospitalisation in the two different types of surgery
timeFrame: From date of surgery until the discharge (0-30 days)
measure: Success rate of the totally intracorporeal procedure in patients with deep endometriosis with bowel involvement undergoing segmental resection surgery
timeFrame: At 3 months after surgery
measure: 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
timeFrame: At 3 months after surgery
measure: Incidence of post-operative complications in the two different surgical treatments
timeFrame: Within 3 months of surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Diego Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References: