IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
NCT Number: NCT06761157
Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery
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Notify Me18 year–50 year
Female
Observational
Bologna, 40138, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months after surgery
Ratio 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
Time frame: During surgery
Ratio of the number of procedures in which any of the intraoperative complications described above occurred to the total number of procedures using rectosigmoidoscopy
Time frame: 3 months after surgery
Ratio of the number of surgeries in which any of the above postoperative complications occurred to the total number of surgeries using rectosigmoidoscopy
Time frame: 3 months after surgery
Percentage 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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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