Page 203 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

Table 1. Summary of recommendations for reporting outcome results in abdominal wall surgery as formulated by the panel of a consensus meeting held by the EuraHS working group in Palermo, Italy, June 2012.
Recommendations IH research
Topic Study type
Reporting guidelines
Prospective vs retrospective
Primary endpoint or variable
Blinded assessment
Sample size
Inclusion criteria, exclusion criteria and eligibility
Dropouts
Classi cations Hernia size
Surgical technique
Meshes and devices
Mesh size and xation
Time-to-event analysis
Recurrence rate
Mean follow-up
Method of follow- up
Ethical considerations
Financial disclosures
Negative trial results
Recommendation
The title and/or the abstract of the manuscript should have a clear description
of the study type.
Use standardised reporting guidelines (CONSORT, TREND, STROBE, STARLITE,
PRISMA, MOOSE) to prepare a study protocol or manuscript.
The abstract should report whether the study is prospective or retrospective, i.e. whether the data for the primary endpoint is assessed prospectively.
Clearly de ne the primary endpoint or variable of the study, including the population analysed (ITT or PP) and a detailed description of how, when and by whom this primary endpoint was assessed.
State wether the evaluation of the primary endpoint was performed by a person blinded to the treatment group of the patient.
Describe the method used for calculating the sample size and the software used for it.
Give a clear description of the study population by listing the inclusion criteria and exclusion criteria. Report the number of eligible patients not included in the study and the reasons for non-inclusion.
The percentage of patients not available for evaluation of the primary endpoint
should be given, including the reasons for “lost to follow-up”.
The use of a ow diagram of the patients in the study is recommended. 9
We recommend using the EHS classi cation for inguinal and ventral hernias.
The width and the length of the hernia from an intraoperative measurement are most appropriate.
When the hernia defect size is reported the method of calculating this size should be given.
The surgical techniques used in the study should be described in enough detail that the reader could perform the technique him or herself.
When referring to speci c equipment items, we recommend the inclusion of the generic name (e.g. polypropylene), the product name and the manufacturer.
Report on the size of the implanted mesh, the overlap of the hernia defect and the xation method in detail.
Time to event analysis using Kaplan-Meier estimates of “freedom of recurrence” is the preferred method for analysis of recurrences in hernia repair patients.
A recurrence rate should be given on the ITT population and reported with 95% con dence intervals. The duration of follow-up at which the recurrence rate was measured should be given.
If a mean follow-up time is given, the range should be given as well.
We recommend to consider only clinically evaluated patients as adequate follow- up to evaluate recurrence.
In large patient registries clinical follow up in all patients is not achievable. Alternatively, follow-up with questionnaires and selective clinical follow-up is proposed.
Every study should mention the approval of the institutional ethical committee and informed consent of the patients.
Financial support of the study or the investigators should be mentioned by name of the organisation or company. Distinguish “Investigator Initiated Studies” from studies initiated by a commercial sponsor of the study.
Negative ndings or outcome of a study should not be a reason not to submit a manuscript. If methodologically correct, negative results can be informative.
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