Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery

NCT05315765 | Unknown

• 2 other identifiers: STH20670NIHR 201492
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus; Small Bowel Obstruction; Intestinal Failure

Keywords

PROM; surgery

Outcome Measures

Primary Outcomes (3)

• Completion of interviews (stage one)

  completions of interview by group 1

  Within one month of treatment

• Completion of questionnaire (stage three)

  completion of questionnaire by group 3

  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

  Within one month of treatment

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Non conversationaI standard of English
• Unable to provide informed consent

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ileus; Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Matthew Lee, PhD

  University of Sheffied and Sheffield Teaching Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debby Hawkins, PhD

CONTACT

01142434343; debby.hawkins@nhs.net

Study Design

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

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: April 7, 2022
• Study Start: October 28, 2021
• Primary Completion: January 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)