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Transrectal Evaluation After Discoid Resection for Endometriosis Intestinal

Transrectal Evaluation After Discoid Resection For Endometriosis Intestinal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06761157
Enrollment
19
Registered
2025-01-07
Start date
2022-03-21
Completion date
2024-03-29
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Endometriosis

Keywords

endometriosis, discoid resection, deep endometriosis, intestinal

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Success rate of rectosigmoidoscopic procedure in patients with deep endometriosis with bowel involvement undergoing segmental or discoid resection surgery3 months after surgeryRatio of the number of successfully completed interventions to the total number of interventions performed using rectosigmoidoscopy. The success of the intervention is determined following qualitative evaluation of the anastomosis

Secondary

MeasureTime frameDescription
Incidence of intraoperative complications: rectorrhagia, leakage, mucosal crash, intussusception, anastomosis stenosis, intraperitoneal hemorrhage, conversion to laparotomy surgeryDuring surgeryRatio of the number of procedures in which any of the intraoperative complications described above occurred to the total number of procedures using rectosigmoidoscopy
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 rectosigmoidoscopy3 months after surgeryRatio of the number of surgeries in which any of the above postoperative complications occurred to the total number of surgeries using rectosigmoidoscopy
Operating time duration in patients undergoing discoid or segmental resection with or without the use of intraoperative rectosigmoidoscopy3 months after surgeryPercentage difference between average surgical durations in patients undergoing resection surgery with and without a rectosigmoidoscopy procedure. Lacking baseline data, an increase, compared with patients who did not undergo rectosigmoidoscopy, of up to 20% in average surgical time is considered reasonable

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026