European Journal of Cardiovascular Medicine

The peritoneum is the largest serosal membrane in the human body and serves as a critical anatomical and functional barrier within the abdominal cavity. Structurally, it is divided into two distinct layers: the visceral peritoneum, which envelops the surfaces of the intra-abdominal organs, and the parietal peritoneum, which lines the internal surface of the abdominal wall, including the diaphragm and the pelvic cavity. These two layers together create the peritoneal cavity, a potential space that under normal conditions contains approximately 75 mL of sterile peritoneal fluid. This fluid acts as a lubricant, reducing friction between the abdominal organs and allowing smooth visceral movement. Notably, the peritoneum's surface area is nearly 2 square meters, which is remarkably comparable to the surface area of human skin, highlighting its extensive presence and physiological importance within the abdominal compartment [1].

Peritonitis refers to the inflammation of the peritoneum and represents a critical abdominal emergency that requires prompt diagnosis and intervention. It is a severe and potentially life-threatening condition that usually results from bacterial or fungal infections, most often due to the perforation of a hollow viscus, such as a section of the gastrointestinal tract or genitourinary system. In other instances, peritonitis may develop as a complication of abdominal surgical procedures or from hematogenous spread in immunocompromised individuals. Based on its etiology and clinical characteristics, peritonitis is broadly categorized into three types. The first is primary peritonitis, which occurs due to an external infectious source, commonly presenting as a monomicrobial infection and frequently seen in patients with cirrhosis and ascites. The second type, secondary peritonitis, results from an intra-abdominal pathological process, such as perforation of a hollow organ (e.g., appendix, stomach, intestines), traumatic injury, or postoperative leakage. The third type, tertiary peritonitis, emerges after the successful treatment of secondary peritonitis and is typically characterized by persistent or recurrent infection within the peritoneal cavity, often involving resistant or opportunistic organisms [2].

The management of peritonitis is often complex and demands a multifaceted clinical approach due to the high rates of associated morbidity and mortality. Patients with peritonitis frequently present in a state of systemic inflammatory response or sepsis, and if not managed promptly, the condition can progress to multi-organ dysfunction. The outcome of peritonitis is influenced by a wide range of interconnected factors, including patient-specific variables such as age, immune status, and comorbid conditions; disease-specific parameters such as the source and extent of contamination; and the quality and timeliness of diagnostic and therapeutic interventions [3]. Optimal treatment requires a systematic approach, beginning with hemodynamic stabilization and fluid resuscitation. Once the patient is stabilized, surgical intervention is typically warranted. This includes exploratory laparotomy to identify and control the source of infection, repair of the perforated viscus or organ, and the irrigation and drainage of the contaminated peritoneal cavity to reduce bacterial load and inflammatory debris [4-6].

Among the various intraoperative measures, peritoneal lavage plays a pivotal role in the treatment of peritonitis. It involves the irrigation of the peritoneal cavity using sterile solutions to physically remove infectious materials, necrotic tissue, inflammatory exudates, and microbial toxins. This technique not only helps in cleansing the peritoneal surfaces but also enhances antibiotic penetration and reduces postoperative septic complications. Over the years, several types of lavage fluids have been explored for their potential therapeutic efficacy. The most commonly used solution is normal saline, valued for its isotonic properties and ease of availability. However, other solutions, particularly those containing antimicrobial agents such as metronidazole, have also been employed with the aim of augmenting the antiseptic effects of lavage.

Metronidazole, a synthetic nitroimidazole derivative, is widely recognized for its antibacterial and antiprotozoal activity, particularly against anaerobic organisms. It exerts its antimicrobial effect by disrupting the DNA synthesis in microbial cells, thereby inhibiting the formation of nucleic acids and ultimately leading to cell death. Given that anaerobic bacteria are frequently implicated in intra-abdominal infections, metronidazole presents a logical choice for intraperitoneal lavage. Several clinical and experimental studies have investigated the use of antibiotic-infused lavage solutions, including those containing metronidazole, chloramphenicol, cephalosporins, and imipenem [7-13].

Research findings in this domain have produced varied results. Bhushan C et al. reported that the use of antibiotic lavage led to a significant reduction in postoperative sepsis and mortality in patients undergoing surgery for peritonitis [9]. Other studies have observed favorable trends in terms of reduced surgical site infections, postoperative intra-abdominal abscess formation, and systemic septic complications in patients who received antibiotic lavage compared to those who received plain saline; however, in many cases, these differences did not reach statistical significance [8, 10, 11, 13]. Interestingly, in a comparative study, the use of imipenem lavage demonstrated a statistically significant reduction in wound infection rates, intra-abdominal abscess formation, and sepsis when compared to saline lavage [12]. These findings suggest that the choice of lavage fluid could have meaningful implications for patient outcomes, particularly in severe intra-abdominal infections like peritonitis.

In light of the ongoing debate and the absence of a clear consensus regarding the most effective peritoneal lavage solution, the present study aims to perform a comparative evaluation of saline and metronidazole lavage in patients undergoing surgery for peritonitis. By closely analyzing and comparing the clinical outcomes associated with each lavage solution, including infection control, incidence of postoperative complications, duration of hospitalization, and overall mortality, this study aims to generate robust clinical data to inform evidence-based decision-making in the surgical management of peritonitis.

This study was designed as a prospective, randomized, comparative study and was conducted at the Indira Gandhi Institute of Medical Sciences (IGIMS), Patna, Bihar over a period of one year. A total of 100 patients diagnosed with perforation peritonitis and requiring surgical intervention were included over the study period. The patients were allocated into two groups of 50 each, based on the peritoneal lavage solution administered during surgery. To reduce selection bias and improve the internal validity of the study, patients were randomly assigned to the two groups using a computer-generated randomization sequence.

• Group A: Received intraoperative peritoneal lavage with 100 mL of metronidazole diluted in 2 liters of normal saline.
• Group B: Received 2 liters of normal saline alone for peritoneal lavage.

In both groups, after completion of the surgical procedure and lavage, abdominal drains were placed and kept clamped for one hour postoperatively to allow retention of the lavage solution, thereby enhancing its potential therapeutic effect.

Patients in both groups were monitored postoperatively using standardized clinical and laboratory parameters. The primary outcomes compared between the two groups included the incidence of wound dehiscence, intra-abdominal abscess formation, sepsis, and duration of hospital stay.

All data were collected systematically and analyzed to evaluate the comparative effectiveness of metronidazole versus saline peritoneal lavage in improving clinical outcomes in operated cases of perforation peritonitis. All participants included in the study provided informed written consent for participation and the use of their diagnostic and clinical data for research purposes. The study was conducted in full accordance with ethical standards and adhered to the principles outlined in the Declaration of Helsinki.

Sample Size Calculation:

The sample size for the present study was determined using a power analysis conducted with G*Power software, version 3.0.1 (Franz Faul, Universität Kiel, Germany). The calculation was performed with an alpha level of 5% (α = 0.05), a power of 80% (1-β = 0.80), and an anticipated effect size of 0.6, based on clinical outcomes reported in a previous study comparing peritoneal lavage methods [11]. This ensured sufficient statistical power to detect meaningful differences in postoperative outcomes, such as sepsis, surgical site infections, and hospital stay, between the metronidazole and saline lavage groups. The resulting sample size of 100 patients (50 in each group) was considered adequate to yield statistically reliable and clinically relevant conclusions.

Inclusion criteria:

The study included all patients diagnosed with perforation peritonitis who underwent laparotomy and were found to have pneumoperitoneum and free intraperitoneal fluid, as confirmed by ultrasound or contrast-enhanced computed tomography (USG/CECT) of the abdomen. Participation was limited to patients who voluntarily agreed to enroll in the study after providing written informed consent.

Exclusion criteria:

Patients were excluded from the study if they were managed non-surgically for peritonitis or had any contraindications to peritoneal lavage. Additional exclusion criteria included a known history of hypersensitivity or allergic reaction to either saline or metronidazole, as well as pregnant or breastfeeding women. Patients with severe coexisting medical conditions, such as end-stage renal disease, hepatic failure, or immunodeficiency, were also excluded. Furthermore, individuals currently participating in another clinical trial or research study were not considered for inclusion in this investigation.

In the majority of cases, the diagnosis of peritonitis was confirmed using an erect abdominal radiograph, particularly in patients who presented with classical clinical features such as abdominal pain, distension, and vomiting. In select cases where further diagnostic clarity was needed, abdominal ultrasonography (USG) was supplemented with a contrast-enhanced computed tomography (CT) scan. In addition, a set of routine hematological and biochemical investigations was performed to assess the patient’s baseline status and guide perioperative management. Patients received appropriate intravenous fluid resuscitation and broad-spectrum antibiotics as part of preoperative stabilization. Prior to surgical intervention, the nature of the illness, proposed treatment plan, and potential prognosis were thoroughly explained to the patient and their family members in their native language, ensuring informed understanding and cooperation.

Study Procedure:

The enrolled patients were divided into two groups based on the type of intraoperative peritoneal lavage administered: the metronidazole lavage group (Group A) and the plain saline lavage group (Group B). In the plain saline group, patients received intraperitoneal lavage with 2 liters of sterile normal saline. In the metronidazole group, the lavage consisted of 2 liters of normal saline combined with 100 mL (500 mg) of metronidazole. Lavage was initiated after surgical closure of the perforation and was carried out over a duration of 20 minutes in both groups.

To minimize bias, the lavage procedure in each case was conducted by a clinician other than the operating surgeon. Patients were closely monitored throughout their hospital stay for postoperative complications, which were documented until discharge or death. The length of postoperative hospitalization was also recorded for outcome assessment.

Postoperative care was provided in a standardized manner across both groups in an institutional setting. Patients underwent regular monitoring of vital signs and fluid input-output measurements. Comprehensive clinical assessments and relevant laboratory investigations were performed to guide recovery. All patients received appropriate analgesia and were encouraged to engage in early ambulation and limb exercises, both passive and active. In addition, chest and limb physiotherapy sessions were conducted three times daily to prevent respiratory and musculoskeletal complications. Patients also practiced incentive spirometry thrice daily to improve pulmonary function during the recovery period.

A uniform antibiotic protocol was administered postoperatively to all patients. This included metronidazole 500 mg IV every 8 hours for seven days, along with piperacillin/tazobactam 4.5 g IV every 8 hours, and amikacin 500 mg IV every 12 hours. All antibiotics were administered under close supervision and adjusted as per clinical and microbiological response.

Statistical Analysis:

All collected data were entered into Microsoft Excel and subsequently analyzed using Statistical Package for the Social Sciences (SPSS), version 25.0 (IBM Corp., Armonk, NY). Continuous variables were expressed as mean ± standard deviation and compared using the Student’s t-test or Mann-Whitney U test, as appropriate. Categorical variables were presented as frequencies and percentages and analyzed using the Chi-square test or Fisher’s exact test. A p-value < 0.05 was considered statistically significant.

The age distribution of patients in the two study groups was comparable. In the metronidazole group (Group A), 38% of patients were aged below 40 years, 40% were between 41-60 years, and 22% were above 60 years. In the normal saline group (Group B), 36% of patients were below 40 years, 46% were between 41-60 years, and 18% were above 60 years. The difference in age distribution between the groups was not statistically significant (p = 0.804). The mean age of patients in Group A was 48.65±8.35 years, while in Group B it was 46.89±7.64 years. This difference was also not statistically significant (p = 0.274), indicating that the two groups were comparable in terms of age [Table 1].

Table 1: Age-wise distribution of patients in the study groups

The gender distribution among patients in the two study groups was comparable. In the Metronidazole group (Group A), 76% of the patients were male (n=38) and 24% were female (n=12). In the Normal Saline group (Group B), 68% were male (n=34) and 32% were female (n=16). Statistical analysis using the Chi-square test yielded a Chi-square (X²) value of 0.446 with a corresponding p-value of 0.504, indicating that the difference in gender distribution between the two groups was not statistically significant (Table 2 and Figure 1).

Table 2: Gender-wise distribution of patients in the study groups

Figure 1: Gender composition of patients in the study groups

The causes of peritonitis among patients in both study groups were varied and showed a broadly similar distribution. Gastric perforation was the most common cause overall, accounting for 23% of cases, with 22% in the metronidazole group (n=11) and 24% in the normal saline group (n=12). Duodenal perforation was responsible for 13% of cases, with 12% in Group A (n=6) and 14% in Group B (n=7). Jejunal perforations contributed to 8% of the total, equally distributed across both groups (n=4 each). Ileal perforation was another major cause, seen in 31% of cases—30% in the metronidazole group (n=15) and 32% in the saline group (n=16). Appendicular perforation accounted for 12% of all cases, with a slightly higher proportion in the metronidazole group (14%, n=7) compared to the saline group (10%, n=5). Caecal perforation was identified in 7% of patients, with 6% in Group A (n=3) and 8% in Group B (n=4). Colonic perforation occurred in 5% of cases, with 6% in the metronidazole group (n=3) and 4% in the saline group (n=2). Rectal perforation was the least common cause, observed in only one patient (1%) in the metronidazole group and none in the saline group. Overall, the etiology of peritonitis showed no significant difference between the two groups, with gastric and ileal perforations being the most frequently observed causes across the study population [Table 3].

Table 3: Different causes of peritonitis in the study groups

Patients in group A had significantly shorter hospital stays than those in group B. A majority (72%) of group A were discharged within 10 days, compared to only 32% in group B (X² = 16.03, p < 0.001). Similarly, the mean hospital stay was markedly lower in group A (9.23 ± 1.24 days) versus group B (12.46 ± 1.95 days; p < 0.001) (Table 4 and Figure 2).

Table 4: Comparison of hospital stay in the study groups

Figure 2: Comparison of postoperative hospital stay between study groups

Group A demonstrated significantly lower rates of surgical site infection (20% vs. 32%, p = 0.037) and sepsis (16% vs. 44%, p = 0.001). Notably, 40% of group A patients had no complications, whereas all saline patients experienced at least one complication (p < 0.001). No statistically significant differences were observed for intra-abdominal abscess (p = 0.343) or wound dehiscence (p = 0.113) [Table 5].

Table 5: Comparison of outcomes in the study groups

[*statistically significant difference]

Mortality: No mortality was reported in either the metronidazole or saline lavage groups during the postoperative period. All patients survived to discharge.

Perforation peritonitis remains one of the most frequent surgical emergencies encountered in clinical practice. Despite considerable advancements in surgical techniques and perioperative care, patients continue to face a high incidence of postoperative complications, contributing significantly to morbidity and mortality. Among the critical steps in the operative management of peritonitis is peritoneal lavage, which plays a pivotal role in reducing the peritoneal bacterial load, inflammatory debris, and toxin levels. The choice of fluid used for lavage may influence the postoperative outcome, particularly in terms of infection control and recovery time. In the present study, the mean age of patients was 48.65 ± 8.35 years in Group A (metronidazole lavage) and 46.89 ± 7.64 years in Group B (saline lavage), with no statistically significant difference between the groups. The majority of patients were male, which is consistent with other studies on perforation peritonitis. The most frequent causes of peritonitis in this cohort were ileal perforation, gastric perforation, and appendicular perforation. All patients received intraoperative peritoneal lavage with either normal saline or metronidazole in saline. Although multiple parameters favored metronidazole lavage, statistically significant improvement was observed in two key areas: postoperative sepsis and duration of hospital stay. These findings suggest that metronidazole, due to its broad-spectrum antimicrobial activity, enhances the effectiveness of lavage and contributes to better clinical outcomes. Our findings are consistent with earlier research. Bhushan C et al. reported a significant decline in mortality and sepsis rates among patients who received antibiotic lavage, including metronidazole [9]. Similarly, Sulli D and Rao MS observed reductions in infection, sepsis, hospital stay, and mortality in the metronidazole group, although the differences were not statistically significant [10]. Choudhary V and Dhankar AA also reported lower incidences of wound infection, sepsis, and intra-abdominal abscess formation in the metronidazole group; however, these differences did not reach statistical significance [11]. In contrast, a study by Santosh CS et al. comparing imipenem lavage with saline demonstrated a statistically significant reduction in wound infections, intra-abdominal abscesses, sepsis, and mortality in the antibiotic lavage group [12]. The results of the current study add further evidence to the growing body of literature supporting the use of antibiotic solutions, particularly metronidazole, in peritoneal lavage during surgery for perforation peritonitis. The observed reduction in sepsis and hospital stay in the metronidazole group highlights the potential role of targeted antimicrobial lavage in enhancing postoperative recovery. Table No. 6 summarizes the findings of the present study alongside observations reported by various other researchers globally. This comparative overview reinforces the clinical relevance of the choice of lavage fluid in improving patient outcomes in perforation peritonitis.

Table 6: Showing a comparison of outcomes reported by different studies

Surgical site infection: In the present study, the incidence of surgical site infection (SSI) was found to be 12% lower in the metronidazole lavage group compared to the saline group, and this difference was statistically significant (p=0.037). This suggests that the addition of metronidazole to peritoneal lavage may contribute to better control of postoperative infection by reducing residual microbial contamination in the peritoneal cavity. A review of existing literature presents mixed findings regarding the effectiveness of various lavage solutions in preventing SSIs. Studies evaluating super-oxidized solution lavage have shown no significant advantage over normal saline, indicating limited clinical benefit. Interestingly, some trials have reported that povidone-iodine and saline lavage may be more effective than metronidazole lavage in reducing wound infections, though these findings vary in significance depending on the study design and population. Among the various agents studied, imipenem lavage has shown the most promising results, with one study reporting a 33% reduction in wound infection rates, which was also statistically significant [12]. The superior performance of imipenem may be attributed to its broad-spectrum antimicrobial coverage, including resistance against many gram-negative and anaerobic organisms commonly implicated in intra-abdominal sepsis. Although metronidazole may not be the most potent option compared to advanced agents like imipenem, its availability, cost-effectiveness, and anaerobic coverage make it a valuable and practical choice for intraoperative lavage, especially in resource-limited settings.

Intra-abdominal abscess: In the present study, the incidence of postoperative intra-abdominal abscess formation was found to be 6% lower in the metronidazole lavage group compared to the saline group; however, this difference did not reach statistical significance (p = 0.343). Although the trend suggests a possible clinical benefit of metronidazole lavage in reducing localized intra-abdominal infections, the results indicate that this reduction may not be substantial enough to establish metronidazole lavage as superior for this specific outcome. This finding aligns with observations from previous studies, where metronidazole, povidone-iodine, and superoxidized solution lavages also failed to show any significant advantage over normal saline in preventing intra-abdominal abscesses. These results suggest that while these agents may contribute to general infection control, their specific role in preventing abscess formation remains limited. In contrast, imipenem lavage has demonstrated a statistically significant reduction in intra-abdominal abscess formation, as reported by Santosh CS et al. [12]. The efficacy of imipenem is likely due to its broad antimicrobial spectrum, particularly its activity against resistant gram-negative and anaerobic organisms commonly associated with peritoneal contamination. Given the relatively low but consistent trend of reduced abscess formation with metronidazole, further large-scale randomized trials are needed to determine whether this benefit can be substantiated and whether it holds clinical significance when weighed against cost and accessibility in routine surgical settings.

Sepsis: In the present study, the incidence of postoperative sepsis was significantly lower in the metronidazole group, showing a 28% reduction compared to the saline group, with the difference being statistically significant (p=0.001). This finding reinforces the therapeutic advantage of using metronidazole lavage during surgery for peritonitis, as it effectively targets anaerobic bacteria commonly implicated in intra-abdominal infections and systemic inflammatory responses. Several other studies have reported similar trends. When metronidazole lavage was compared to normal saline, a reduction in postoperative sepsis was consistently observed, although the degree of reduction and statistical significance varied depending on the study design and patient population [14-16]. However, when metronidazole lavage was compared to povidone-iodine lavage, no appreciable difference in sepsis rates was found, suggesting that both agents may offer comparable antimicrobial efficacy in terms of systemic infection control. Among all the agents evaluated, imipenem lavage has shown the most remarkable benefit. In the study by Santosh CS et al., sepsis was reduced by 23.3%, and the difference was statistically significant [12]. This superior outcome is likely due to imipenem’s broad-spectrum activity, including efficacy against multidrug-resistant gram-negative organisms and anaerobes. While metronidazole may not match the efficacy of imipenem in every aspect, its targeted anaerobic coverage, lower cost, and wide availability make it a practical and effective option in reducing sepsis in patients undergoing surgery for perforation peritonitis, particularly in low- and middle-income settings.

Hospital stay: In the present study, patients in the metronidazole lavage group experienced a significantly shorter duration of hospital stay compared to those in the saline group, with the difference being statistically significant (p<0.001). This reduction in hospitalization time reflects not only the improved control of infection and inflammation in the metronidazole group but also the faster overall recovery and lower incidence of postoperative complications. Comparable findings have been reported in previous research. Schein M et al. observed that patients treated with chloramphenicol lavage had a mean hospital stay of 10 days, which was notably shorter than the 13-day stay reported in the saline lavage group [8]. This suggests that the use of antimicrobial lavage solutions, whether metronidazole or chloramphenicol, may contribute to faster convalescence by minimizing systemic infectious complications and promoting quicker return of normal physiological functions. The reduction in hospital stay associated with metronidazole lavage not only benefits patients by reducing exposure to hospital-related complications but also has positive economic implications, particularly in resource-limited healthcare settings. Shorter hospital stays translate into reduced bed occupancy, lower treatment costs, and better utilization of institutional resources. These findings support the growing clinical rationale for adopting antibiotic-enhanced lavage, specifically with metronidazole, as a cost-effective adjunct in the surgical management of peritonitis.

The absence of mortality in our study may be attributed to early surgical intervention, standardized postoperative care, and strict monitoring protocols. Although other studies have reported varied mortality rates, particularly in the saline group, our findings reflect favorable outcomes in a controlled tertiary care setting. However, a larger sample size may be necessary to adequately assess mortality differences.

Limitations of the study: This study was limited by its single-center design and relatively small sample size. Blinding was not possible, which may have introduced observer bias. Long-term outcomes were not assessed.

This study demonstrates that intraoperative peritoneal lavage with metronidazole significantly reduces postoperative sepsis, surgical site infections, and hospital stay compared to saline lavage in patients undergoing surgery for perforation peritonitis. Metronidazole lavage appears to be a safe and effective adjunct in the surgical management of peritonitis, contributing to fewer complications and faster recovery. While these findings are promising, larger multicentric randomized controlled trials are warranted to confirm these results and support broader clinical adoption.

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