Clinical trial NCT05315765: Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
Official title: Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ileus
Small Bowel Obstruction
Intestinal Failure
Keywords: PROM
surgery
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2022-04-07
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or gynaecological indications OR patients being treated for intestinal obstruction regardelss of aetiology.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of interviews (stage one)
timeFrame: Within one month of treatment
measure: Completion of questionnaire (stage three)
timeFrame: Within two weeks of treatment
measure: Completion of face validity assessment (stage two)
timeFrame: Within one month of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: University of Sheffied and Sheffield Teaching Hospitals
name: Matthew Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: