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NCT Number: NCT05682690

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients having intraoperative complications

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Intraoperative blood loss (ml)

    Time frame: 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

    Time frame: During the surgical procedures

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

  3. Operative time (min)

    Time frame: 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

    Time frame: During the surgical procedures

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

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

Laparoscopic Eradication of Deep Endometriosis With Nerve-sparing Rectosigmoid Segmental Resection: a Comparative Retrospective Analysis (RSRES_NERVSP)

Acronym: RSRES_NERVSP

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2023
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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