About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with a known concomitant inflammatory bowel syndrome (inflammatory bowel syndrome)
Patients undergoing emergency/emergency surgery
Trial population
Patients with deep endometriosis with suspected bowel involvement and intraoperative indication for segmental resection
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Detect any differences in the duration of the total operating time in the two different treatments
Total operating time measured in minutes
Duration of hospitalisation in the two different types of surgery
Measurement of hospitalisation time after surgery
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
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
Sponsors and contacts
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