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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-54
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Evaluation by scoring the validated Low Anterior Resection Syndrome score questionnaire

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

Secondary outcomes

1

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

Total operating time measured in minutes

Time frame
During surgery
2

Duration of hospitalisation in the two different types of surgery

Measurement of hospitalisation time after surgery

Time frame
From date of surgery until the discharge (0-30 days)
3

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

Time frame
At 3 months after surgery
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

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

Time frame
At 3 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: