Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery

Ileus Clinical Trial

— PRO-diGI  

Official title:

Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315765
• Other study ID #: STH20670
• Secondary ID: NIHR 201492
• Status: Recruiting
• Start date: October 28, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2022
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: Debby Hawkins, PhD
• Phone: 01142434343
• Email: debby.hawkins[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

People who undergo surgery, or develop intestinal obstruction will spend a period of time without normal bowel function. This might extend beyond the normal measures of passage of flatus or tolerance of diet. This study will take a three stage approach to develop a patient reported outcome measure for gastrointestinal recovery.

Stage 1: Qualitative interviews with 20-40 patients who have undergone major abdominal surgery, or conservatively managed intestinal obstruction. These interviews will identify key themes and ideas to develop the questionnaire.

Stage 2: Face validity testing of questionnaire with 20 patients, using the QQ-10 questionnaire to aid assessment. The questionnaire may be edited after this.

Stage 3: 250-500 patients will be asked to complete the questionnaire following surgery or treatment for intestinal obstruction. Basic demographics will also be collated. Item reduction and scale refinement will be undertaken using this dataset. This will provide a PROM of gastrointestinal recovery which is ready for validation.

Description:

Gastrointestinal dysfunction is commonly seen after surgery, and also manifests itself in intestinal obstruction. During this time, the patient may experience a range of symptoms of acute intestinal failure, including loss of motility and absorption. These may resolve at different rates during the period of gastrointestinal recovery. Trials in the area have conflicting results, partly due to the selection of clinician reported unidimensional outcomes. There is a clear need for a patient reported outcome measure (PROM) to record gastrointestinal recovery.

Aims and Objectives

• To develop a PROM for gastrointestinal recovery.

• To identify a candidate long-list of items for inclusion in a PROM through semi-structured patient interviews, and test face validity with patients and an expert panel

• To develop a PROM using the approved long list

Methods This study will be conducted in three stages with reference to FDA (Food and Drug Administration) and ISOQoL (International Society for Quality of Life Research) guidelines.

Stage 1: Five centres will undertake purposive sampling to identify patients who have undergone major intraabdominal surgery (including gastrointestinal, urological, and gynaecological) and patients treated for intestinal obstruction. It is expected that 40-60 participants will undergo a semi-structured interview to identify important items related to recovery of gastrointestinal function in order to reach thematic saturation. Interviews will be transcribed and coded using a framework methodology. This will generate allow us to construct a prototype questionnaire with an initial pool of items.

Stage 2: The prototype questionnaire will be shown to a group of international experts in gastrointestinal recovery for assessment of face validity, using the QQ-10 (Questionnaire quality-10 item) questionnaire. This will then be tested with 20 patients treated for eligible conditions at five participating centres using the QQ-10.

Stage 3: Upto 500 participants (depending on number of items on the questionnaire) will be recruited from 10 centres which offer gastrointestinal, urological, and gynaecological surgery. Participants will rate items on a Likert scale. Items will undergo factor analysis to reduce the number of items. This will present a shorter questionnaire with finalised scales.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: March 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients (aged 18+) admitted to hospital for one of the following reasons will be eligible to participate:

• Undergoing major elective gastrointestinal surgery (e.g. colorectal resection, gastric resection, liver or pancreatic resection)

• Emergency laparotomy for non-trauma indication

• Patients undergoing intra-abdominal surgery for non-gastrointestinal indications e.g.cystoprostatectomy, prostatectomy, nephrectomy, hysterectomy, or oophorectomy.

• With a diagnosis of intestinal obstruction (small or large bowel).

• Participants are permitted to participate in another study or trial in addition to PRO-DIGI

Exclusion Criteria:

• Non conversationaI standard of English

• Unable to provide informed consent

Related Conditions & MeSH terms

• Ileus
• Intestinal Failure
• Intestinal Obstruction
• Small Bowel Obstruction

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of interviews (stage one)	completions of interview by group 1	Within one month of treatment
Primary	Completion of questionnaire (stage three)	completion of questionnaire by group 3	Within two weeks of treatment
Primary	Completion of face validity assessment (stage two)	Assessment of face validity using the QQ-10 (Questionnaire quality-10 item) questionnaire by group 2	Within one month of treatment