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

NCT03824054 | Completed

• 1 other identifier: CICOG-31-10-18\100
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis

Keywords

deep infiltrating endometriosis; colorectal resection; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (1)

colorectal resection arm

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

Procedure: colorectal resection

Interventions

colorectal resection PROCEDURE

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

Also known as: ileostomy creation

colorectal resection arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 31758304 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Francesco Cosentino, MD

  francesco.cosentino@fgps.it

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: January 31, 2019
• Study Start: October 1, 2005
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

IT (1)