Patients Undergoing Total Intracorporeal or Extracorporeal Anastomosis After Segmental Resection for Deep Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Deep Endometriosis. Basic parameters: 18 years — 54 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Study Between Patients Undergoing Total Intracorporeal Anastomosis Or Extracorporeal Anastomosis After Segmental Resection For Deep Endometriosis
Overview
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
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Detect any differences in the duration of the total operating time in the two different treatments [Time frame: During surgery]
- Duration of hospitalisation in the two different types of surgery [Time frame: 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 [Time frame: 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 [Time frame: At 3 months after surgery]
- Incidence of post-operative complications in the two different surgical treatments [Time frame: Within 3 months of surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06826378 · ARISTOTLE23