Recommendations for reporting outcome results in abdominal wall repair: results of a Consensus meeting in Palermo, Italy, 28-30 June 2012.

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. 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.

EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair.

BACKGROUND: Although the repair of ventral abdominal wall hernias is one of the most commonly performed operations, many aspects of their treatment are still under debate or poorly studied. In addition, there is a lack of good definitions and classifications that make the evaluation of studies and meta-analyses in this field of surgery difficult. MATERIALS AND METHODS: Under the auspices of the board of the European Hernia Society and following the previously published classifications on inguinal and on ventral hernias, a working group was formed to create an online platform for registration and outcome measurement of operations for ventral abdominal wall hernias. Development of such a registry involved reaching agreement about clear definitions and classifications on patient variables, surgical procedures and mesh materials used, as well as outcome parameters. The EuraHS working group (European registry for abdominal wall hernias) comprised of a multinational European expert panel with specific interest in abdominal wall hernias. Over five working group meetings, consensus was reached on definitions for the data to be recorded in the registry. RESULTS: A set of well-described definitions was made. The previously reported EHS classifications of hernias will be used. Risk factors for recurrences and co-morbidities of patients were listed. A new severity of comorbidity score was defined. Post-operative complications were classified according to existing classifications as described for other fields of surgery. A new 3-dimensional numerical quality-of-life score, EuraHS-QoL score, was defined. An online platform is created based on the definitions and classifications, which can be used by individual surgeons, surgical teams or for multicentre studies. A EuraHS website is constructed with easy access to all the definitions, classifications and results from the database. CONCLUSION: An online platform for registration and outcome measurement of abdominal wall hernia repairs with clear definitions and classifications is offered to the surgical community. It is hoped that this registry could lead to better evidence-based guidelines for treatment of abdominal wall hernias based on hernia variables, patient variables, available hernia repair materials and techniques.

Helium vs carbon dioxide gas insufflation with or without saline lavage during laparoscopy.

BACKGROUND: Helium is an inert gas that, if used for insufflation during laparoscopy, may be followed by less postoperative pain than carbon dioxide (CO2) insufflation, due to a more limited effect on intraabdominal pH and metabolism. Saline lavage has also recently been shown to reduce postoperative pain following laparoscopic surgery. To evaluate these possibilities and to better define the clinical safety of helium insufflation, we undertook a prospective randomized trial comparing CO2 and helium insufflation with or without saline lavage in patients undergoing elective laparoscopic upper abdominal surgery. METHODS: From January to November 2000, 173 patients undergoing elective laparoscopic cholecystectomy or fundoplication were randomized to undergo laparoscopy with either CO2 or helium insufflation. Within each group, patients were further randomized to undergo peritoneal lavage with 2 L of 0.9% saline at the end of the surgical procedure. This yielded the following four patient groups; CO2 (group 1, n = 47), CO2 + saline lavage (group 2, n = 43), helium (group 3, n = 43) and helium + saline lavage (group 4, n = 40). Patients were blinded to their randomization, and post-operative assessment was also performed by a blinded investigator, who applied a standardized scoring system to assess postoperative pain. RESULTS: The study groups were well matched for age, sex, weight, American Society of Anesthesiologists (ASA) status, duration of surgery, and volume of gas utilized, and 81% of patients were discharged within 48 h. There were no differences in the incidence of postoperative complications among the study groups, and postoperative pain scores were not significantly different when all four groups were compared. When helium (groups 3 and 4) was compared with CO2 (groups 1 and 2), no differences in pain score were seen. When no lavage (groups 1 and 3) was compared with lavage (groups 2 and 4), less pain was found in the group undergoing saline peritoneal lavage (mean 4-h pain score, 5.9 vs 5.2; 24-h pain score, 4.8 vs 4.1; p > 0.05). CONCLUSIONS: The use of helium insufflation for laparoscopic surgery, while not associated with any significant adverse sequelae, was not associated with less postoperative pain in this trial. The use of saline peritoneal lavage was associated with less pain in the early postoperative period.

Prospective analysis of a scoring system to predict choledocholithiasis.

BACKGROUND: The management of choledocholithiasis in the laparoscopic era remains debatable. A common policy is to perform preoperative endoscopic retrograde cholangiopancreatography (ERCP) on patients suspected of having common bile duct (CBD) stones, using standard risk criteria. The aim of this study was to evaluate prospectively a scoring system designed to improve the accuracy of CBD stone prediction before laparoscopic cholecystectomy. METHODS: Known clinical, biochemical and radiological risk factors for CBD stones were analysed retrospectively in 233 patients. The presence (n = 77) or absence (n = 156) of CBD stones was determined by preoperative ERCP and/or laparoscopic cholangiography. Using multivariate analysis, the significant risk factors for CBD stones were identified and a new preoperative scoring system was developed. A score of 3 or more was taken as the cut-off point to suggest CBD stones and the need for preoperative ERCP. This scoring system was then tested prospectively in 211 consecutive patients with symptomatic gallstones requiring surgery. Patients whose bile ducts could not be demonstrated by ERCP or operative cholangiography were excluded. RESULTS: Fifty-five patients scored 3 or more (predicted ERCP rate of 29 per cent), of whom 23 (42 per cent) had proven CBD stones. Intraoperative cholangiography was successful in 87 per cent. Five patients (4 per cent) who scored less than 3 had small stones (less than 5 mm) demonstrated at operative cholangiography. The overall sensitivity and specificity of this scoring were 82 and 80 per cent respectively. CONCLUSION: Formal risk assessment of the presence of CBD stones using this scoring system is simple and may be used for preoperative selection of patients for biliary tract imaging by magnetic resonance cholangiography or ERCP.