IleusPRO-diGINCT05315765
Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
An observational study of Ileus and Small Bowel Obstruction, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus, Small Bowel Obstruction, Intestinal Failure
- How many people
- 560 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2021to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or gynaecological indications OR patients being treated for intestinal obstruction regardelss of aetiology.
Who may be able to join
- 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
Who cannot join
- Non conversationaI standard of English
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
Debby Hawkins, PhD, +44 0114 2434343, debby.hawkins@sth.nhs.uk
Matthew J Lee, MBChB PhD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Ileus, Small Bowel Obstruction, Intestinal Failure
- Keywords
- PROM, surgery
- Medical subject headings
- Ileus, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Qualitative interviews with patients to generate thematic framework and questionnaire | |
| Phase 2 | Face validity assessment of questionnaire | |
| Phase 3 | Completion of questionnaire to refine scale and item list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of interviews (stage one)
completions of interview by group 1
Measured: Within one month of treatment
Completion of questionnaire (stage three)
completion of questionnaire by group 3
Measured: 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
Measured: Within one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start28 Oct 2021
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Matthew Lee, PhD, Principal investigator, University of Sheffied and Sheffield Teaching Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315765
- Sponsor's protocol ID
- STH20670
- Other IDs
- NIHR 201492
- Acronym
- PRO-diGI
- Status last verified
- Mar 2022
- First submitted
- 7 Oct 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
- ClinicalTrials.gov ID
- NCT05315765
- Acronym / sponsor ID
- PRO-diGI / STH20670
- Conditions
- Ileus, Small Bowel Obstruction, Intestinal Failure
- Keywords
- PROM, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | –Qualitative interviews with patients to generate thematic framework and questionnaire |
| Phase 2 | – | –Face validity assessment of questionnaire |
| Phase 3 | – | –Completion of questionnaire to refine scale and item list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing major abdominal surgery for gastrointestinal, urological, or gynaecological indications OR patients being treated for intestinal obstruction regardelss of aetiology.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- Non conversationaI standard of English
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of interviews (stage one)
Time frame: Within one month of treatment
completions of interview by group 1
Completion of questionnaire (stage three)
Time frame: Within two weeks of treatment
completion of questionnaire by group 3
Completion of face validity assessment (stage two)
Time frame: Within one month of treatment
Assessment of face validity using the QQ-10 (Questionnaire quality-10 item) questionnaire by group 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Lee, PhD principal investigator
University of Sheffied and Sheffield Teaching Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileus and Small Bowel Obstruction, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debby Hawkins, PhD (01142434343, debby.hawkins@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of interviews (stage one) (time frame: Within one month of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.