Clinical trial NCT05682690: Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection (RSRES_NERVSP)
Official title: Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection: a Comparative Retrospective Analysis (RSRES_NERVSP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 3072
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectosigmoid endometriosis who underwent classic or nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022

Brief summary: This is a single-center, retrospective case-control study. All consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022 will be included. In the majority of cases classic segmental rectosigmoid resection was done between January 2005 and December 2010. Nerve-sparing segmental rectosigmoid resection has been increasingly employed since January 2011 until now. Preoperative (anamnestic, physical objective, and ultrasonographic data), surgical and postoperative data of the patients included in this study will be analyzed. In particular, postoperative data will be obtained by analyzing reports of follow-up visits, which are routinely done at our institution at 1, 6, 12 months and then every year following the surgical procedures.


Eligibility criteria: Inclusion Criteria:

* consecutive women who underwent classic and nerve-sparing segmental rectosigmoid resection between January 2005 and June 2022
* age more than 18 years.

Exclusion Criteria:

* diagnosis of other/concomitant preoperative and/or postoperative medical or surgical conditions altering pelvic organ function (i.e. multiple sclerosis, irritable bowel syndrome);
* age \<18 years.

Primary outcomes:
measure: Number of patients having intraoperative complications
timeFrame: During the surgical procedures
measure: Number of patients having short-term postoperative complications
timeFrame: 3 months after the surgical procedures
measure: Number of patients having middle-term postoperative complications
timeFrame: 6 months after the surgical procedures
measure: Number of patients having long-term postoperative complications
timeFrame: 12 months after the surgical procedures
Secondary outcomes:
measure: Intraoperative blood loss (ml)
timeFrame: During the surgical procedures
measure: Number of patients having an intraoperative laparotomic conversion
timeFrame: During the surgical procedures
measure: Operative time (min)
timeFrame: During the surgical procedures
measure: Number of patients undergoing a concomitant additional surgical procedure
timeFrame: During the surgical procedures
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria di Negrar
state: Verona
Study officials:
affiliation: IRCCS Sacro Cuore Don Calabria
name: Marcello Ceccaroni
role: PRINCIPAL_INVESTIGATOR
References: