Clinical trial NCT06761157: Transrectal Evaluation After Discoid Resection for Endometriosis Intestinal
Official title: Transrectal Evaluation After Discoid Resection For Endometriosis Intestinal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Endometriosis
Keywords: endometriosis
discoid resection
deep endometriosis
intestinal
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with deep endometriosis with suspected bowel involvement who will undergo segmental or discoid resection for the period of one year following the date of study approval

Brief summary: Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery

Detailed description: Endometriosis is an inflammatory, benign, oestrogen-dependent condition that affects 10-15% of women of reproductive age. It is characterised by the presence of endometrial tissue, glands and stroma, outside the uterine cavity. Endometriosis may present in the pelvis as superficial peritoneal, ovarian or deep infiltrating. The reported prevalence of bowel or recto-vaginal space involvement among women with endometriosis ranges from 5% to 25% (2). Surgery is the treatment of choice for deep endometriosis with bowel involvement when drug therapy alone is ineffective in treating symptoms. Surgical techniques for intestinal endometriosis can be divided into full-thickness techniques (discoid or segmental resection) and non-full-thickness techniques (shaving).

Focusing on women who underwent a discoid resection, 3.7% of 80 reported a recto-vaginal fistula and the same percentage showed early rectorrhagia requiring endoscopic treatment after surgery. In general surgery rectosigmoidoscopy has shown encouraging results as a feasible, safe and effective technique in reducing the risk of complications related to intestinal anastomosis. There are no studies in the literature evaluating the role of rectosigmoidoscopy as a routine practice in gynaecological surgery for endometriosis, so we rely on the experience of general surgeons. In particular, the lack of data does not allow us to evaluate the feasibility of rectosigmoidoscopy during deep endometriosis surgery in terms of the success of the procedure itself and the additional operative time taken. The latter aspect is also important from the point of view of health policy due to the increased cost of the operating theatre directly related to the time taken for the procedure.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 50 years
* Women with diagnosis made by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected bowel involvement
* Women undergoing segmental or discoid resection for bowel endometriosis
* Obtaining informed consent

Exclusion Criteria:

* Patients who are candidates for elective laparotomic surgery
* Patients with concomitant inflammatory bowel disease known in history (inflammatory bowel syndrome)

Primary outcomes:
measure: Success rate of rectosigmoidoscopic procedure in patients with deep endometriosis with bowel involvement undergoing segmental or discoid resection surgery
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Incidence of intraoperative complications: rectorrhagia, leakage, mucosal crash, intussusception, anastomosis stenosis, intraperitoneal hemorrhage, conversion to laparotomy surgery
timeFrame: During surgery
measure: Incidence of postoperative complications within the first three months post-segmental or discoid resection surgery among patients undergoing rectosigmoidoscopy and patients undergoing the same surgery without rectosigmoidoscopy
timeFrame: 3 months after surgery
measure: Operating time duration in patients undergoing discoid or segmental resection with or without the use of intraoperative rectosigmoidoscopy
timeFrame: 3 months after 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: Paolo Casadio, MD
role: PRINCIPAL_INVESTIGATOR
References: