An observational study in Ileus, Small Bowel Obstruction and Intestinal Failure, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational
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.
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
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 560 is above the median of 159 across 26 observational studies indexed under Ileus.
Browse Ileus studies →Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 214 studies on the registry; 27 are open to participants now.
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Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or gynaecological indications OR patients being treated for intestinal obstruction regardelss of aetiology.
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Adult patients (aged 18+) admitted to hospital for one of the following reasons will be eligible to participate:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Qualitative interviews with patients to generate thematic framework and questionnaire
Face validity assessment of questionnaire
Completion of questionnaire to refine scale and item list
Completion of interviews (stage one)
completions of interview by group 1
Time frame: Within one month of treatment
Completion of questionnaire (stage three)
completion of questionnaire by group 3
Time frame: Within two weeks of treatment
Completion of face validity assessment (stage two)
Assessment of face validity using the QQ-10 (Questionnaire quality-10 item) questionnaire by group 2
Time frame: Within one month of treatment
Plan to share: No — Anonymised transcriptions of phase one interviews will be made available on our institution open access data repository. Other data relates to refinement of the PROM and is not relevant outside of this study.
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Jan 2023, 15 months after the start.
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Sheffield Teaching Hospitals NHS Foundation Trust →