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

Endometriosis Clinical Trial

— ENDO-RESECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824054
• Other study ID #: CICOG-31-10-18\100
• Status: Completed
• Start date: October 1, 2005
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2019
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• colorectal resection
Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)	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	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary	Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality	Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of anxiety, depression, positivity and well-being, self control, general health and vitality, through the administration of the PGWBI (Psychological General Well-Being Index) to patients. The PGWBI is a brief self-administered questionnaire which contains 20 items rated on a six-point scale, where a higher score indicates a better quality of life and measures six mood states (anxiety, depressed mood, positive well-being, self-control, general health, vitality). The six mood states are scored as follows: 25 for anxiety, 20 for positive well-being and vitality and 15 for remaining	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary	Pre-post colorectal resection-and-anastomosis evaluation of the coping ability of daily living	Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the coping ability of daily living, through the administration of the GSE (General Self-Efficacy Scale) to patients.; The GSE consists of 10 items, with a 4-point Likert scale ranging from 1 (I Completely Disagree) to 4 (I Completely Agree), aimed at identifying, as expressed in the introduction, self-efficacy beliefs in view of difficult situations	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary	Pre-post colorectal-resection-and-anastomosis evaluation of patients ability to "thrive in the face of adversity"	Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the ability to "thrive in the face of adversity", through the administration of the CD-RISC (Connor-Davidson Resilience Scale) to patients.; The CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary	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)	Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (work and family life, sexual life, fertility issues), through the administration of the EHP-30(Endometriosis Health Profile questionnaire).The EHP-30 consists of a 30-item core questionnaire, covers five subscales (11 items on pain, 6 on control and powerlessness, 6 on emotions, 4 on social support, 3 on self-image), and a second 23-item modular questionnaire contains six subscales (5 items on work life, 2 on relationship with children, 5 on sexual intercourse, 4 on medical profession, 3 on treatment and 4 on infertility). Response categories are rated on a five-point Likert scale (0-4), and items within each subscale are summed to create a raw-score.Each raw scale is translated into a score ranging from 0(best possible health status) to 100 by dividing the total raw scores in each subscale by the maximum possible raw-score within the subscale and multiplying it by 100	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary	Pre-post colorectal-resection-and-anastomosis evaluation of the menstrual pain	Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the menstrual pain, through the administration of the VAS (Visual Analogic Scale) to patients. The VAS using a 10-cm line represented the continuum of the patient's opinion of the degree of pain. One extremity of the line represented "unbearable pain," and the other extremity represented "no pain at all." The participants were asked to rate the degree of pain by making a mark on the line. The scores received from the scale were classified into mild dysmenorrhea if it was between 1 and 3 points moderate between 4 and 7 points, and severe between 8 and 10 points	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary	Prevalence of post-operative complications (rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding)	Perioperative and post-operative complications were 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). Major complications were defined as those requiring surgical, endoscopic, or radiological intervention (grade III or higher according to the Clavien-Dindo classification), and include rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding after surgery. Minor complications were defined as those that could be solved with a conservative approach (Clavien-Dindo grade I and II)	from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)