Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection (RSRES_NERVSP)

Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar (Other)
Overall Status
Completed
CT.gov ID
NCT05682690
Collaborator
(none)
3,072
1
9
10389.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3072 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection: a Comparative Retrospective Analysis (RSRES_NERVSP)
    Actual Study Start Date :
    Oct 1, 2022
    Actual Primary Completion Date :
    Oct 10, 2022
    Actual Study Completion Date :
    Oct 10, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients having intraoperative complications [During the surgical procedures]

      Number of patients having intraoperative complications evaluated by surgical data stored in the hospital medical electronic register

    2. Number of patients having short-term postoperative complications [3 months after the surgical procedures]

      Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits

    3. Number of patients having middle-term postoperative complications [6 months after the surgical procedures]

      Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits

    4. Number of patients having long-term postoperative complications [12 months after the surgical procedures]

      Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits

    Secondary Outcome Measures

    1. Intraoperative blood loss (ml) [During the surgical procedures]

      Intraoperative blood loss (ml) evaluated by surgical data stored in the hospital medical electronic register

    2. Number of patients having an intraoperative laparotomic conversion [During the surgical procedures]

      Intraoperative blood loss (ml) evaluated by surgical data stored in the hospital medical electronic register

    3. Operative time (min) [During the surgical procedures]

      Operative time (min) evaluated by surgical data stored in the hospital medical electronic register

    4. Number of patients undergoing a concomitant additional surgical procedure [During the surgical procedures]

      Number of patients undergoing a concomitant additional surgical procedure evaluated by surgical data stored in the hospital medical electronic register

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Sacro Cuore Don Calabria di Negrar Negrar Verona Italy

    Sponsors and Collaborators

    • IRCCS Sacro Cuore Don Calabria di Negrar

    Investigators

    • Principal Investigator: Marcello Ceccaroni, IRCCS Sacro Cuore Don Calabria

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IRCCS Sacro Cuore Don Calabria di Negrar
    ClinicalTrials.gov Identifier:
    NCT05682690
    Other Study ID Numbers:
    • 2022-ZF
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 17, 2023