SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Questionnaire (SBS QoL)

NCT06771505 | Recruiting

• 2 other identifiers: 69HCL24_08892024-A02032-45
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). This tool may seem complex and tedious to use in everyday practice. However, it is important to regularly assess the quality of life of these patients. This is why the investigators are proposing to create a new tool for more rapid assessment of the quality of life of patients with short bowel syndrome.

Conditions

Short Bowel Syndrome

Keywords

Short Bowel syndrome; Quality of life

Outcome Measures

Primary Outcomes (1)

• Validation of a new quality of life tool, the SBS disk, in comparison with a quality of life assessment tool, the SBS QoL.

  Self-questionnaire in the form of a disk which covers 10 themes: Energy, stress level, anxiety, diet, abdominal pain, transit, appliances, social life, social and professional activity, sleep, as well as self-image and intimate life, according to the recommendations of the WHO quality of life assessment. These themes are the same as those generally covered by the SBS QoL reference questionnaire, with the exception of self-image and intimacy. The themes are evaluated according to the patient's feelings during the past week on a scale from 0 to 10.

  Day 1

Study Arms (1)

Questionnaire completion

The partient completes the two quality of life assessment questionnaires (Short Bowel Syndrome Quality of Life (SBS QoL) and SBS disk assessment tool), in paper format.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will focus on adult patients with short bowel syndrome followed up in the GHS Intensive Clinical Nutrition Department, during a consultation, a day hospital or a conventional hospital stay.

You may qualify if:

• Age 18 or over
• Patient able to read and speak French
• Patient suffering from short bowel syndrome

You may not qualify if:

• Known cognitive disorders

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Lyon Sud - CHLS

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte BERGOIN, Doctor

  Service d'hépato-gastro-entérologie et Assistance nutritionnelle - Hôpital Lyon Sud - CHLS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte BERGOIN, Doctor

CONTACT

+33 04.78.86.38.69; charlotte.bergoin@chu-lyon.fr

Stéphanie PECORA, Dietician

CONTACT

+33 04.78.86.8.69; stephanie.pecora@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (1)