Discussion
seroma, hernia
MINOR, SURGICAL SITE INFECTION, RECRUITMENT, COMPLICATION, SECONDARY, SURGICAL COMPLICATIONS, SEROMA, COMPLICATIONS
This prospective randomized study assessed the role of intraoperatively placed drains to avoid postoperative fluid collection after open incisional hernia repair. Postoperative fluid collections were observed in both groups in up to 65% of patients, and drain placement could not decrease the incidence of that particular complication at POD 30. This rate of collection seems important; however, only a small amount was clinically relevant. Although the trial was negative on the primary endpoint, the secondary endpoints highlighted significant results in terms of morbidity. There were significantly fewer overall complications on POD 30 in the drain group and a lower rate of surgical complications. These findings will be discussed in more detail below.There is no clear evidence in the current literature regarding the prophylactic use of drains. In a prospective study including 42 patients in 2015, Westphalen et al. reported a similar rate of seroma in patients with drains (52.4%) versus quilting sutures (42.9%) on POD 30. A retrospective study of Krpata et al. in 2017 analyzed complications after drainage in incisional hernia repair with a retromuscular mesh [The high complication rate in our study (29% in the drainage group; 50.7% in the control group) is explained by a compulsory and institutionally-organized system of complication recording, including minor complications graded I and II according to Clavien-Dindo classification. The higher rate of surgical complications in the group without drainage might suggest that drainage could prevent complications other than fluid collection, and therefore positively influence postoperative outcomes. Although drainage was predictive of a lower CCI, it did not reflect on hospital stay or readmission rate. In addition, the severity of complications graded by Clavien-Dindo classification was similar in both groups.We investigated which subtype of complication was most present in each group. The surgical site infection rate was comparable in both groups (5.9% vs. 9.3%, The strength of the present study relies on its high-standard prospective, randomized design and also on the recording of objective and quantifiable endpoints. External validity is high since inclusion criteria did not select the type of initial surgery or patient comorbidities. The sample represents a standard population making it easily reproducible for further investigation. The 10-year recruitment period is a drawback since laparoscopic surgeries have become widely popular. These minimally-invasive procedures competed with our study and limited recruitment. After careful evaluation of this situation with our ethical committee, the study had to be terminated prematurely and the number of participants estimated by the initial power calculation has not been reached. In our opinion, the value of the present study remains strong, as these novel approaches are still not widely accepted or implemented, and open surgery remains the gold standard for the majority of surgeons. In addition, the 144 included patients represent a large population when compared to other series. Since this study was terminated prematurely due to the expansion of minimally invasive techniques, it would be interesting to repeat this research with other techniques, such as minimal invasive approaches or onlay mesh placement. Finally, according to our primary endpoint, the study was negative. However, a clinically relevant conclusion is in our view appropriate.