| Objective: |
Research Summary – Objective: Our objectives are:
1. To follow patients with symptomatic pilonidal sinus referred to each collaborating site,
prospectively recording details of their pit / track anatomy, surgical management, medical
events, health-related quality of life until six months after their operation.
2. To describe the combination of interventions currently in use and quantify clinical and
patient-reported outcomes associated with each.
3. To identify patient-specific disease features that might predict poor outcome in each treatment group by risk-modelling methods.
4. To derive a case-mix adjusted estimate of the risks associated with common treatment
options, using causal inference methods to provisionally rank the optimal management
strategies among patients for whom more than one treatment is considered appropriate.
5. To provide an overview of patient views and experiences.
6. To collect the views of patients on which interventions they would rather avoid and which outcomes they most value.
7. To reach a surgeon-based consensus on which subtypes of pilonidal disease may benefit from which treatment options
8. To reach a surgeon and patient-based consensus on research priorities.
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| Aim: |
We aim to answer the following questions:
1. What are the different subtypes of pilonidal disease for which the various treatment options are indicated?
2. What combinations of excision and closure techniques are used?
3. Which outcomes do patients value and which interventions do they prefer?
4. What further research is needed?
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| Methods: |
Research Summary – Methods: (1) A prospective, observational cohort study at 15 centres, with statistical modelling of patients with pilonidal sinus. Patients will be recruited for 15 months and followed up for six months from the date of their operation. This component will establish optimal management strategies and what types of disease are better treated with which intervention, meeting Objectives 1-4.
(2) A nested mixed-methods case study involving brief semi-structured interviews with patients with different sinus anatomy and treatment choices, providing an overview of patient views and experiences, around the time of surgery and six months’ later. This component will meet Objective 5 and partially fulfill Objective 6.
(3) A discrete choice experiment which will elicit patients’ preferences and trade-offs for patient important outcomes (e.g. return to normal activities, recurrence etc.). This will tell us which outcomes are most valued by patients, and are there particular interventions that patients would rather avoid. This component will fulfill Objective 6.
(4) A modified Nominal Group Technique (NGT) exercise involving 40 surgeons, hosted by the ACPGBI in July 2021 to “review… results together in a consensus meeting, with the aim of identifying whether the pooled data allow surgeons to agree on a definitive trial which they can do”, in line with the IDEAL Framework. Patients will also be in attendance and will have the opportunity to comment on the acceptability of proposed comparators and confirm valued outcomes for any future randomised controlled trial, meeting Objective 7 and 8.
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| Reason for International Trial: |
Not international but collaboration with Australian researchers.
Seeking UK Centres Only |