Evaluation of Quality of Life and Gastrointestinal Well-being in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis. Retrospective Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Catholic University of the Sacred Heart
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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).
Investigators
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart
Eligibility Criteria
Inclusion Criteria
- •Women aged between 18 and 45 years
- •Clinical diagnosis of deep endometriosis infiltrating the bowel
- •Women undergoing surgical removal with colorectal resection with or without loop ileostomy creation
Exclusion Criteria
- •History of previous or ongoing neoplastic pathology
- •Contraindications to surgical intervention
- •Not complete eradicating surgery
- •Psychiatric disorders
- •Surgical, spontaneous or pharmacological menopause - Intestinal surgery different from segmental bowel resection and colorectal anastomosis
Outcomes
Primary Outcomes
Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)
Time Frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching, through the administration of the GSRS (Gastrointestinal Symptom Rating Scale) to patients. The GSRS is a disease-specific instrument that includes 15 items combined into five-symptom clusters addressing different gastrointestinal symptoms. The five-symptom clusters depict reflux, abdominal pain, indigestion, diarrhoea and constipation. The GSRS has a seven-graded scale where 1 represents absence of bothersome symptoms and 7 represents very bothersome symptoms
Secondary Outcomes
- Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality(from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months))
- Pre-post colorectal resection-and-anastomosis evaluation of the coping ability of daily living(from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months))
- Pre-post colorectal-resection-and-anastomosis evaluation of patients ability to "thrive in the face of adversity"(from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months))
- Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (includes work and family life, sexual life, fertility issues)(from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months))
- Pre-post colorectal-resection-and-anastomosis evaluation of the menstrual pain(from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months))
- Prevalence of post-operative complications (rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding)(from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months))