Clinical trial NCT03824054: Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis
Official title: Evaluation of Quality of Life and Gastrointestinal Well-being in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis. Retrospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: deep infiltrating endometriosis
colorectal resection
quality of life
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and candidate to colo-rectal resection

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).

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

Primary outcomes:
measure: Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Secondary outcomes:
measure: Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
measure: Pre-post colorectal resection-and-anastomosis evaluation of the coping ability of daily living
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
measure: Pre-post colorectal-resection-and-anastomosis evaluation of patients ability to "thrive in the face of adversity"
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
measure: 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)
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
measure: Pre-post colorectal-resection-and-anastomosis evaluation of the menstrual pain
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
measure: Prevalence of post-operative complications (rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding)
timeFrame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
affiliation: francesco.cosentino@fgps.it
name: Francesco Cosentino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turco LC, Scaldaferri F, Chiantera V, Cianci S, Ercoli A, Fagotti A, Fanfani F, Ferrandina G, Nicolotti N, Tamburrano A, Vargiu V, Scambia G, Cosentino F. Long-term evaluation of quality of life and gastrointestinal well-being after segmental colo-rectal resection for deep infiltrating endometriosis (ENDO-RESECT QoL). Arch Gynecol Obstet. 2020 Jan;301(1):217-228. doi: 10.1007/s00404-019-05382-8. Epub 2019 Nov 22.