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Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)
Hana Tabusa1, Jane M Blazeby1, Natalie Blencowe1
1University of Bristol, Bristol, UK.
Insights
Parastomal hernia (PSH) affects many patients after abdominal surgery. The CIPHER study investigates surgical techniques to prevent PSH, aiming to improve patient outcomes and reduce complications.
Area of Science:
- Surgical innovation
- Patient outcomes
- Hernia research
Background:
- Parastomal hernia (PSH) is a common complication after abdominal surgery requiring stoma creation.
- PSH affects up to 40% of patients within two years, leading to reduced quality of life and severe complications like bowel obstruction.
- Current management of PSH is challenging, with high recurrence rates after surgical repair, emphasizing the need for preventative strategies.
Purpose of the Study:
- To investigate the influence of various surgical techniques on the development of parastomal hernia (PSH).
- To identify modifiable surgical factors contributing to PSH incidence in patients undergoing stoma formation.
Main Methods:
- The CIPHER study is a UK cohort study recruiting 4000 patients undergoing stoma surgery (ileostomy or colostomy).
- Detailed surgical methods, including trephine formation, mesh reinforcement, and wound closure, are recorded for each patient.
- Primary outcome is incident PSH, assessed via symptoms and CT scans; secondary outcomes include surgical site infection, complications, quality of life, and resource use.
Main Results:
- Data collection and analysis are ongoing.
- Study results will be published in peer-reviewed journals under corporate authorship 'The CIPHER Study Investigators'.
Conclusions:
- The CIPHER study is the first to examine detailed stoma formation techniques in a large, diverse patient cohort.
- Findings are expected to inform best practices for stoma surgery to minimize PSH development.
- This research aims to significantly reduce the incidence and impact of PSH on patient well-being.
Aim:
Abdominal surgery sometimes necessitates the creation of a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia adjacent to and related to the stoma. PSH affects approximately 40% of patients within 2 years of stoma formation. Complications of PSH reduce a patient's quality of life and can be severe (e.g. bowel obstruction). PSHs are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The aim of the CIPHER study is to investigate the influence of different surgical techniques on the development of PSH.
Method:
The UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study) aims to recruit 4000 patients undergoing elective or expedited surgery with the intention of forming an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons will describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as a specimen extraction site and wound closure. The primary outcome will be incident PSH during follow-up, defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes will include surgical site infection, the Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources.
Results:
Results of the study will be submitted for publication in peer-reviewed journals. All publications relating to the results of CIPHER will use a corporate authorship, 'The CIPHER Study Investigators' with named writing committee members.
Conclusion:
The CIPHER study will be the first to investigate detailed surgical methods of stoma formation in a large, representative cohort of patients with a range of primary indications, both cancer and noncancer.
