Recommendations for reporting outcome results in abdominal wall repair

Abstract

Background The literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology. Materials and methods The EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction. Hernia (2013) 17:423-433 DOI 10.1007/s10029-013-1108 Results A list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of ''time-to-event analysis'' to report data on ''freedom-of-recurrence'' rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods. Conclusion A set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.

A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument

“…There is an increasing interest in assessing the quality of treatment by evaluating the QoL with PROMs. [1][2][3][4][5][9][10][11] Ideally, PROMs should also include questions about restriction of activities by pain or discomfort in the operated groin, esthetical discomfort, testicular pain, sexual dysfunction, patient anxiety, and patient satisfaction. On the other hand, a good QoL questionnaire should be short and precise, thus a selection of what is considered most relevant has to be made.…”

“…Although the recurrence rate is still an important outcome measure, many researchers now consider patient reported outcome measurement (PROM) of at least equal importance in evaluating the quality of an operation. [1][2][3] This is most relevant when we operate on oligo-or asymptomatic patients. By implantation of a permanent foreign body in the abdominal wall, we risk inducing chronic pain or restriction of the patient's activities and thus impairing the patient's quality of life (QoL).…”

Gentamicin for prevention of intraoperative mesh contamination: demonstration of high bactericide effect (in vitro) and low systemic bioavailability (in vivo)

“…Gramnegative) in vitro and in vivo, including models for infection of soft tissue in the presence of meshes. A prospective clinical study to investigate the effectiveness of topical gentamicin on meshes is scarcely feasible: the low incidence of mesh infections (1-3 %) would require an extremely large patient series, and it is very difficult to randomize such populations [26,34,35]. It is all the more important therefore that all mesh implants are prospectively documented in a hernia registry for surveillance over long-term course, as is being done for example by the EuraHS Registry of Ventral and incisional Hernias of the European Hernia Society [34,35].…”

Laparoscopic ventral hernia repair using a novel intraperitoneal lightweight mesh coated with hyaluronic acid: 1-year follow-up from a case–control study using the Hernia-Club registry

“…Perioperative and 1-year follow-up results were compared between the two groups of patients. This study aimed to follow STROBE recommendations for the reporting of observational studies [21,22].…”