European Journal of Cardiovascular Medicine

Ventral hernia repair is one of the most frequently performed abdominal wall procedures, particularly in patients with prior laparotomies, obesity, or weak musculofascial support [1]. With advancements in mesh materials and surgical techniques, the focus has gradually shifted toward optimizing perioperative strategies to minimize complications and hasten recovery. One such contentious practice is the use of closed suction drains (CSDs) following open ventral hernia repair.

Closed suction drains are traditionally placed with the intention of reducing fluid accumulation, seroma formation, hematoma, and surgical site infections (SSI) [2]. The rationale is that continuous suction facilitates removal of inflammatory exudates and blood, thereby reducing tissue tension and dead space. However, the utility of such drains remains debated. Several studies have shown that the presence of a drain may not significantly alter the rate of seroma formation, and may paradoxically increase the risk of retrograde infections or prolong hospital stays [3,4].

A growing body of literature, including randomized trials and meta-analyses, has suggested that routine use of drains may not be warranted, particularly in elective primary hernia repairs with minimal contamination risk [5]. Furthermore, CSDs have been associated with increased postoperative pain, patient discomfort, and delayed mobility—factors that contradict the goals of enhanced recovery after surgery (ERAS) protocols [6]. Conversely, proponents argue that drains can serve as early indicators of complications such as hematoma or mesh-related fluid collections, thus aiding timely intervention.

The current evidence is further complicated by significant heterogeneity in surgical techniques (onlay vs. sublay vs. underlay mesh placement), the use of biological versus synthetic meshes, and patient-related factors such as obesity, diabetes, and smoking status [7]. Hence, there remains no consensus on the routine versus selective use of drains.

This randomized comparative study aims to evaluate the outcomes of open ventral hernia repair with and without closed suction drainage in a controlled cohort at a tertiary centre in India. Primary outcomes include seroma formation, wound infection, and hospital stay duration; secondary outcomes include postoperative pain scores and patient satisfaction.

Study Design and Setting

This was a single-centre, parallel-group, randomized comparative study conducted at the Department of General Surgery, TRR Institute of Medical Sciences, India, over a 3-year period from January 2022 to January 2025.

Participants

A total of 80 adult patients (age 18–70 years) undergoing elective open ventral hernia repair were enrolled. Patients were randomized into two groups:

• Drain Group (n = 40): Underwent repair with placement of a closed suction drain in the subcutaneous plane.
• No-Drain Group (n = 40): Underwent repair without any postoperative drainage.

Inclusion criteria included patients with primary or incisional midline ventral hernias of size 3–10 cm, suitable for open mesh repair using a standardized sublay technique. Exclusion criteria comprised patients with active infection, immunosuppression, recurrent hernias, strangulated hernias, or those undergoing emergency surgery.

Randomization and Blinding

Randomization was done using a computer-generated block randomization sequence with concealed allocation. Due to the nature of the intervention, blinding of the surgical team was not feasible. However, postoperative outcome assessors were blinded to the group assignment.

Surgical Technique

All patients underwent open ventral hernia repair under general anaesthesia using the retrorectus (sublay) mesh placement technique. Haemostasis was secured meticulously. In the Drain Group, a 16F closed suction drain (Romovac system) was placed in the subcutaneous plane and removed once output was <30 mL/day. In the No-Drain Group, the wound was closed in layers without drainage.

Outcome Measures

Postoperative seroma was assessed clinically and, if needed, confirmed with ultrasonography on day 3, day 7, and at the 30-day follow-up. SSI was defined based on CDC criteria. Pain scores were recorded using the Visual Analog Scale (VAS) at 24 hours, 72 hours, and day 7. Hospital stay duration and patient satisfaction (5-point Likert scale) were also recorded.

Statistical Analysis

Data were analyzed using SPSS version 25. Continuous variables were compared using Student’s t-test or Mann–Whitney U test based on normality. Categorical variables were analyzed using Chi-square or Fisher’s exact test. A p-value <0.05 was considered statistically significant.

Section 1:  Baseline Characteristics

A total of 80 patients undergoing open ventral hernia repair were randomized equally into the Drain group (n = 40) and No Drain group (n = 40). Table 1 presents an extended summary of the demographic and clinical baseline characteristics.

The mean age and BMI were comparable between the two groups (data not shown here for brevity). Males were slightly more prevalent in both groups: 60% in the Drain group and 52.5% in the No Drain group. The burden of comorbidities was balanced, with diabetes present in 27.5% vs. 30%, hypertension in 35% vs. 22.5%, and COPD in 22.5% vs. 5% of Drain and No Drain groups, respectively.

The distribution of hernia type was similar between groups, with a higher proportion of incisional hernias in the Drain group (62.5% vs. 50%). The mean hernia defect size was 25.1 ± 4.9 cm² and 26.9 ± 6.9 cm² in the Drain and No Drain groups, respectively. Mean operative duration was similar across groups (85.9 vs. 84.4 minutes). Most patients were ASA class II, followed by class I and class III. ASA refers to the American Society of Anesthesiologists physical status classification system. *

Table 1. Extended Baseline Characteristics of Study Participants

*ASA Class I = Healthy individual; ASA Class II = Mild systemic disease; ASA Class III = Severe systemic disease (not incapacitating).

Section 2: Postoperative Pain Trends

Postoperative pain scores were recorded using the Visual Analog Scale (VAS) on postoperative Days 1, 3, and 7. As shown in Table 2, patients in the Drain group experienced consistently lower pain scores compared to those in the No Drain group.

On Day 1, the mean VAS score was 4.5 ± 1.1 in the Drain group versus 6.1 ± 1.3 in the No Drain group, indicating greater discomfort in patients without a drain. By Day 3, pain scores declined in both groups but remained lower in the Drain group (3.1 ± 1.1 vs. 4.1 ± 1.1). By Day 7, both groups showed marked pain reduction, with mean scores of 1.2 ± 0.7 for the Drain group and 2.0 ± 1.0 for the No Drain group.

The observed trend suggests that the use of a closed suction drain may contribute to better pain control in the early postoperative period following ventral hernia repair.

Table 2. Postoperative Pain Scores (VAS)

Section 3: Postoperative Complications

Postoperative complications were monitored in both groups during the hospital stay and follow-up period. As detailed in Table 3, patients in the No Drain group experienced higher rates of complications compared to those in the Drain group.

Seroma formation occurred in 20.0% of patients without a drain compared to 7.5% in those with a drain. Surgical site infections (SSI) were also more frequent in the No Drain group (27.5%) than in the Drain group (5.0%). Rates of hematoma and wound dehiscence remained low in both groups, but still trended higher in the No Drain cohort (5.0% vs. 2.5% and 7.5% vs. 2.5%, respectively).

These findings support the hypothesis that closed suction drainage may play a protective role in minimizing postoperative wound-related complications following ventral hernia repair.

Table 3. Postoperative Complications

Section 4: Length of Hospital Stay and Return to Work

Postoperative recovery outcomes were assessed by measuring the duration of hospital stay and the time required for patients to return to work. As shown in Table 4, the Drain group demonstrated a marginally shorter hospital stay compared to the No Drain group.

The mean length of stay was 4.8 ± 1.1 days for the Drain group and 5.3 ± 1.2 days for the No Drain group. Although the difference is modest, it may reflect better wound healing and fewer complications in patients who received closed suction drainage. Similarly, the time to return to work was significantly shorter in the Drain group (10.0 ± 2.0 days) compared to the No Drain group (12.8 ± 2.3 days), suggesting improved postoperative recovery.

These findings indicate that the use of drains may contribute to accelerated convalescence, potentially enhancing patient satisfaction and reducing indirect healthcare costs.

Table 4. Length of Hospital Stay and Return to Work

Section 5: Binary Logistic Regression Analysis for Postoperative Complications

A binary logistic regression model was constructed to identify independent predictors of postoperative complications. The outcome variable was the occurrence of any complication (yes/no), and the predictors included group allocation (Drain vs. No Drain), ASA class, presence of diabetes, and BMI. The results of the regression analysis are presented in Table 5.

Patients in the No Drain group had significantly higher odds of developing postoperative complications (OR = 8.25, 95% CI: 2.52–26.98, p < 0.001), indicating that the absence of a closed suction drain is an independent risk factor. ASA class II was also significantly associated with increased complications (OR = 35.49, 95% CI: 1.91–657.98, p = 0.017), whereas ASA class III approached significance (OR = 19.03, 95% CI: 0.80–454.08, p = 0.069). Diabetes and BMI did not reach statistical significance but showed directional trends suggesting possible clinical relevance.

Table 5. Binary Logistic Regression for Postoperative Complications

Figure1: Binary Logistic Regression Analysis

Figure 1. Forest plot illustrating the odds ratios (OR) with 95% confidence intervals (CI) from the binary logistic regression analysis for predicting postoperative complications. An OR > 1 indicates increased odds of complication. The red dashed line at OR = 1 indicates the null value. Log scale is used for better visualization of wide confidence intervals.

This randomized comparative study assessed the role of closed suction drainage in ventral hernia repair, with a specific focus on postoperative complications and recovery metrics. Our findings demonstrate that the use of drains was associated with a significantly lower rate of postoperative complications and a shorter recovery period, thereby supporting the clinical utility of closed suction drainage in selected cases.

The logistic regression analysis revealed that patients in the No Drain group had a significantly higher odds of developing postoperative complications, which may translate into increased wound morbidity, delayed healing, and prolonged recovery time of developing postoperative complications (OR = 8.25; 95% CI: 2.52–26.98; p < 0.001), even after adjusting for potential confounders such as ASA class, diabetes, and BMI. These results align with previous studies that have suggested a protective effect of drainage in reducing seroma formation and surgical site infection [7,8]. For instance, Chua et al. reported a lower incidence of fluid collection and wound-related complications in patients undergoing laparoscopic hernia repair with drainage [7]. Similarly, Bessa et al. demonstrated a statistically significant reduction in seroma rates with the use of closed suction drains in large incisional hernias [8].

ASA class II (representing patients with mild systemic disease as per the American Society of Anaesthesiologists Physical Status Classification System) also emerged as a statistically significant predictor of complications in our study (OR = 35.49; 95% CI: 1.91–657.98; p = 0.017), indicating that even mild systemic disease can impact postoperative outcomes. This observation resonates with the findings of Miserez et al., who documented higher complication rates in patients with elevated ASA scores undergoing elective hernia repair [9]. Although diabetes and BMI did not reach statistical significance in our analysis, their inclusion helped adjust for known confounders and reflects current best practices in surgical risk modelling [10,11].

Recovery parameters, particularly hospital stay and return-to-work intervals, were also notably better in the Drain group. Patients with drains had a mean hospital stay of 4.8 ± 1.1 days compared to 5.3 ± 1.2 days in the No Drain group. Time to return to work was similarly reduced in the Drain group (10.0 ± 2.0 vs. 12.8 ± 2.3 days). Although the absolute differences were modest and not statistically significant, they may still be clinically meaningful, and these findings are consistent with earlier reports suggesting that better fluid control and reduced early wound complications facilitate faster recovery [12,13]. For example, Krpata et al. emphasized the importance of postoperative drain management in optimizing outcomes following open ventral hernia repair [12].

Pain scores across postoperative days 1, 3, and 7 showed consistently lower values in the Drain group. While we did not pursue a formal repeated measures model due to sample size limitations and the exploratory nature of the study due to limitations in between-group statistical modelling, our groupwise trends reflect those noted by Karandikar et al., who reported lower pain scores and improved analgesic requirements in patients managed with drains after mesh hernioplasty [14]. These reductions in pain likely contributed to the earlier mobilization and return-to-work timelines observed in our cohort.

Our findings reinforce the targeted use of closed suction drainage in ventral hernia repairs. This approach is particularly beneficial for patients at elevated risk of fluid accumulation or surgical site infection in ventral hernia repairs, particularly for patients at elevated risk of fluid accumulation or surgical site infection. However, as highlighted by Berrevoet et al., a universal drainage policy may not be appropriate for all patients, and selective use based on risk stratification remains essential [15].

Limitations

This study has several limitations. Firstly, the relatively small sample size from a single centre may limit the generalizability of the findings. Secondly, the duration of follow-up was confined to the early postoperative period, which may not capture long-term complications such as incisional hernia recurrence or chronic pain. Thirdly, while efforts were made to balance baseline characteristics, the possibility of unmeasured confounders cannot be ruled out. Lastly, subjective variables like pain scoring may be influenced by individual perception despite using a standardized VAS scale.

In this randomized comparative study, the use of closed suction drainage in ventral hernia repair was associated with a significantly lower rate of postoperative complications and a trend toward faster recovery. Logistic regression analysis confirmed that the absence of drainage and higher ASA class were independent predictors of adverse outcomes. These findings support the selective use of closed suction drains, particularly in patients at higher risk of seroma formation or surgical site infection. Further multicentric studies with longer follow-up are warranted to validate these results and guide standardized protocols

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