Clinical Trials Directory

Trials / Completed

CompletedNCT03824054

Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis

Evaluation of Quality of Life and Gastrointestinal Well-being in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis. Retrospective Observational Cohort Study

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Catholic University of the Sacred Heart · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre operative status have been submitted retrospectively, while post operative questionnaires have been submitted prospectively during last follow up visit

Detailed description

All patients fit for the study will be asked to complete a visual analogue scales (VAS) for dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being questionnaires Bristol Stool Chart, GSCG (Gastrointestinal Symptom Rating Scale), STAY (1 and 2), the Psychological General Well-Being Index (PGWBI), Generalized Self-Efficacy, CD-RISC - Connor-Davidson scale about their pre operative and actual status. Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis Perioperative and post-operative complications will be collected using the Extended Clavien-Dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset).

Conditions

Interventions

TypeNameDescription
PROCEDUREcolorectal resectionSurgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis

Timeline

Start date
2005-10-01
Primary completion
2017-11-30
Completion
2018-11-30
First posted
2019-01-31
Last updated
2019-03-28

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03824054. Inclusion in this directory is not an endorsement.