Hernia Incisional clinical trials

Enhanced Recovery After Abdominal Wall Reconstruction

The use of laparoscopy and the ERAS (Enhanced Recovery After Surgery) perioperative pathways are well defined in surgery and widely used worldwide. Predicting the success or failure of ERAS has become a matter of interest, as there is evidence confirming that greater compliance with the items of ERAS improves clinical outcomes. However, the impact that every single item of ERAS programs may have on postoperative recovery remains unknown. Furthermore, the loss of conformity, or deviation from the pathway, is multifactorial and derives from different issues (organizational, cultural, etc.). While data are available on the compliance of surgeons to ERAS pathways, it is impossible to establish which item is related to the benefits induced by ERAS. Regarding abdominal wall reconstruction (AWR) surgery, there is no uniform adherence to the ERAS protocol, often creating confusion about the effectiveness of the protocol itself. The goal of this multicenter, prospective, international, observational study is to prospectively assess adherence to the ERAS protocol in AWR surgery and its effectiveness in patients undergoing elective surgery for ventral primary/incisional hernias. The participating centers will consecutively enroll all patient candidates for an elective ventral or incisional hernia repair (open/laparoscopic/robotic/converted technique). The present study will include all patients ≥18 years old, capable of expressing valid informed consent, with a ventral/incisional hernia diagnosis confirmed by CT/US scan, who will undergo elective surgery. For each patient, anthropometric and personal data (sex, age, BMI) and data relating to their health state (ASA Score, previous abdominal surgery, hernia site) will be collected. Intraoperative data will include the type of surgery and intraoperative complications. Data regarding the adherence/lack of adherence to each item of the ERAS protocol will be collected, and, in the case of non-adherence, the reason will be specified, choosing between "habit", "disagreement", and "lack of organizational pathway", "other". During the post-operative period, all data regarding functional recovery will be recorded, i.e. the day of removal of the drainage, mobilization, return to bowel function, post-operative pain at first and third post-operative day and discharge, and length of hospitalization. Moreover, for each patient, data regarding post-operative complications will be collected and stratified by severity according to the Clavien-Dindo classification. This research is observational; therefore, no interventional changes should be made to the daily clinical practice at each participating center. Patients <18 years old, patients unable to provide valid informed consent, and those who refuse to be included in the study will be excluded. The study's primary objective is to evaluate adherence to the different items of the ERAS protocol for AWR surgery. The study's secondary objective is to evaluate which item of the protocol can affect the post-operative recovery of patients undergoing AWR surgery. The study's primary outcome is the compliance rate for each ERAS item for AWR surgery. The secondary outcomes of the study are the evaluation of complications, length of hospital stay, and recovery time after AWR in relation to compliance with the ERAS items. In addition, the study will evaluate: the time to removal of the drainage tube, if placed (post-operative day, n.), post-operative mobilization (hours, n.), time to resumption of post-operative liquid diet after surgery (hours, n.), time to resumption of liquid diet after surgery (hours, n.), pain at I-II-III post-operative day (VAS Score), time to return to bowel function (gas) (hours, n.), time to return to bowel function (stools) (hours, n.), length of hospital stay (days, n), pain at discharge (VAS Score), post-operative complications (n, within 30 days), type of complication (if any). The complications will be classified according to Clavien-Dindo: Grade I complication according to Clavien-Dindo. Statistical analyses will be performed with the SPSS 27 system (SPSS Inc., Chicago, IL, USA). Continuous data will be expressed as mean ± SD; categorical variables will be expressed as percentages. To compare continuous variables, an independent sample t-test will be implemented. The Wilcoxon Paired-Samples Test will be used as a non-parametric test similar to the paired-samples t-test used for continuous variables. The Chi-square test (or Fisher's exact test where appropriate) will be used to analyze categorical data. The results will be presented as 2-tailed values with statistical significance if p< 0.05. To adjust all other variables and make predictions, multivariate analyses will be performed with operative time or post-operative time or the occurrence of post-operative complications as dependent variables and with significant clinical and demographic characteristics as independent variables.