Establishing core outcome sets for gastrointestinal recovery in studies of postoperative ileus and small bowel obstruction

Gastrointestinal recovery describes the restoration of normal bowel function in patients receiving treatment for bowel disease. This may be prolonged in two settings. The first is postoperative ileus, characterised by reduced or uncoordinated intestinal transit. This occurs in 10-20% of patients undergoing major gastrointestinal surgery, depending on the criteria used for assessment. The second is small bowel obstruction, characterised by intestinal blockage. This is responsible for half of all emergency laparotomies in the United Kingdom and over 300,000 hospital admissions per year in North America. Whilst both represent different aetiologies, the features of gastrointestinal recovery are similar.

Delayed gastrointestinal recovery is distressing for patients. It leads to painful abdominal distension, vomiting, delayed elimination, and prolonged hospital stay. It may also implicate the need for nasogastric decompression. The Association of Coloproctology in Great Britain & Ireland recently identified gastrointestinal recovery as a key research priority during a patient-clinician consensus process. Researchers are limited, however, by methodological challenges related to the definition of normal gastrointestinal function and the selection of clinical outcomes. Recently, two systematic reviews of previous literature identified 73 and 50 outcomes used to measure gastrointestinal recovery in settings of ileus and small bowel obstruction, respectively. This wide variation in reporting limits comparability between studies and is problematic for evaluating new treatments and translating these into practice.

As there is considerable overlap in the features of gastrointestinal recovery between both conditions, co-development of two outcome sets with the scope to combine or segment condition-specific domains will be pursued. This represents an efficient and pragmatic approach.

Contributors

Mr Stephen Chapman, University of Leeds, UK (Co-PI)
Mr Matthew Lee, University of Sheffield, UK (Co-PI)
Miss Sue Blackwell, Patient Representative, UK (Co-PI)
Prof Robert Arnott, Patient Representative, UK (Co-PI)
Dr Richard ten Broek, Radboud University Medical Centre, Netherlands (Co-I)
Prof Conor Delaney, Digestive Disease Institute, Cleveland Clinic, US (Co-I)
Dr Nagendra Dudi-Venkata, University of Adelaide, Australia (Co-I)
Dr Danny Hind, University of Sheffield, UK (Co-I)
Prof David Jayne, University of Leeds (Co-I)
Dr Katie Mellor, University of Sheffield (Co-I)
Assoc. Prof Anurag Mishra, Maulana Azad Medial College, India (Co-I)
Assoc. Prof Greg O'Grady, University of Auckland, New Zealand (Co-I)
Assoc. Prof Tarik Sammour, Royal Adelaide Hospital, Australia (Co-I)
Dr Gabrielle Thorpe, University of East Anglia, UK (Co-I)
Dr Cameron Wells, University of Auckland, New Zealand (Co-I)
Prof Albert Wolthuis, University Hospital Leuven, Belgium (Co-I)
Miss Nicola Fearnhead, Cambridge University Hospitals NHS Foundation Trust, UK (CI)

Further Study Information

Current Stage: Ongoing
Date: January 2020 - December 2021
Funding source(s): Tripartite 2020 Vision Initiative in Colorectal Surgery


Health Area

Disease Category: Gastroenterology

Disease Name: Postoperative ileus , Bowel obstruction

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Charities
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Nominal group technique (NGT)
- Systematic review

An international Steering Group consisting of patient and clinician representatives will be established. As overlap between clinical contexts (postoperative ileus and small bowel obstruction) is anticipated, both outcome sets will be co-developed and may be combined to form a common output with disease-specific domains. The development process will comprise three phases. These include: 1) identification of previous outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal-group stakeholder discussions; 2) online-facilitated Delphi surveys disseminated via international networks; and 3) a consensus meeting to ratify the final output.