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

Endometriosis Clinical Trial

— RSRES_NERVSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682690
• Other study ID #: 2022-ZF
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: January 2023
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3072
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria di Negrar	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients having intraoperative complications	Number of patients having intraoperative complications evaluated by surgical data stored in the hospital medical electronic register	During the surgical procedures
Primary	Number of patients having short-term postoperative complications	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 months after the surgical procedures
Primary	Number of patients having middle-term postoperative complications	Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits	6 months after the surgical procedures
Primary	Number of patients having long-term postoperative complications	Number of patients having short-term postoperative complications evaluated by clinical data stored in the hospital medical electronic register at the follow-up visits	12 months after the surgical procedures
Secondary	Intraoperative blood loss (ml)	Intraoperative blood loss (ml) evaluated by surgical data stored in the hospital medical electronic register	During the surgical procedures
Secondary	Number of patients having an intraoperative laparotomic conversion	Intraoperative blood loss (ml) evaluated by surgical data stored in the hospital medical electronic register	During the surgical procedures
Secondary	Operative time (min)	Operative time (min) evaluated by surgical data stored in the hospital medical electronic register	During the surgical procedures
Secondary	Number of patients undergoing a concomitant additional surgical procedure	Number of patients undergoing a concomitant additional surgical procedure evaluated by surgical data stored in the hospital medical electronic register	During the surgical procedures