Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis (ENDO-RESECT)

Catholic University of the Sacred Heart

Status: Completed

Conditions: Endometriosis

Treatments: Procedure: colorectal resection

Study type: Observational

Funder types: Other

Identifiers

NCT03824054

CICOG-31-10-18\100

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

colorectal resection arm

Description:

Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and submitted to colo-rectal resection

Treatment:

Procedure: colorectal resection