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

NCT ID: NCT03824054

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-01
• Study Completion Date: 2018-11-30

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).

Conditions

Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

colorectal resection arm

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

colorectal resection

Intervention Type: PROCEDURE

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

Interventions

colorectal resection

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

Intervention Type: PROCEDURE

Other Intervention Names

ileostomy creation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Prof. Giovanni Scambia

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Cosentino, MD

Role: PRINCIPAL_INVESTIGATOR

francesco.cosentino@fgps.it

Locations

Catholic University of Sacred Heart

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31758304 (View on PubMed)

Other Identifiers

CICOG-31-10-18\100

Identifier Type: -

Identifier Source: org_study_id