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Research Article | Volume 11 Issue 1 (Jan- Feb, 2025) | Pages 226 - 231
Comparative study on the use of prophylactic drain versus no drains in pancreaticoduodenectomy
1
Associate Professor, Department of Surgical Gastroenterology, Konaseema Institute of Medical Sciences, Amalapuram, Andhra Pradesh, India .
Under a Creative Commons license
Open Access
Received
Jan. 17, 2025
Revised
Jan. 24, 2025
Accepted
Feb. 20, 2025
Published
Feb. 27, 2025
Abstract
Background: Pancreaticoduodenectomy (PD) is associated with significant postoperative morbidity, with pancreatic fistula and intra-abdominal complications being the most common. The role of prophylactic abdominal drains in preventing these complications remains controversial. Objective: To compare postoperative outcomes in patients undergoing PD with prophylactic abdominal drains versus those without drains. Methods: This prospective comparative study included 80 patients undergoing elective PD, divided into Drain Group (Group A) and No-Drain Group (Group B). Postoperative outcomes, including clinically relevant postoperative pancreatic fistula (CR-POPF), intra-abdominal abscess, delayed gastric emptying, wound infection, length of hospital stay, and 30- and 90-day mortality, were recorded and analyzed. Continuous variables were compared using Student’s t-test and categorical variables were compared using Chi-square or Fisher’s exact test. A p-value <0.05 was considered statistically significant. Results: A total of [specify number] patients were included, with 40 in each group. CR-POPF occurred in 12.5% of the Drain Group and 10% of the No-Drain Group (p = 0.73). Rates of intra-abdominal abscess (7.5% vs. 5%), delayed gastric emptying (15% vs. 12.5%), wound infection (10% vs. 7.5%), 30-day mortality (2.5% vs. 0%), and 90-day mortality (5% vs. 2.5%) were comparable between groups. Mean hospital stay was 12.3 ± 4.1 days in the Drain Group and 11.1 ± 3.8 days in the No-Drain Group (p = 0.18). No statistically significant differences were observed in any postoperative outcomes. Conclusion: Omission of prophylactic abdominal drainage in selected patients undergoing PD does not increase postoperative complications or mortality. A no-drain policy may be safely implemented in low- to moderate-risk patients, potentially reducing morbidity, improving patient comfort, and optimizing healthcare resources.
Keywords
INTRODUCTION
Pancreaticoduodenectomy (PD), commonly referred to as the Whipple procedure, remains the cornerstone surgical intervention for pancreatic head and periampullary tumors, as well as selected benign pancreatic lesions [1,2]. Despite advances in surgical techniques, perioperative care, and patient selection, PD continues to be associated with significant morbidity and mortality. Postoperative pancreatic fistula (POPF), delayed gastric emptying, intra-abdominal abscess, hemorrhage, and sepsis are among the most frequent complications, which can substantially prolong hospitalization, increase healthcare costs, and adversely impact patient outcomes [3-5]. Historically, prophylactic abdominal drains have been routinely placed following PD to evacuate intraperitoneal fluid collections, detect early complications, and potentially reduce the incidence of intra-abdominal sepsis [6,7]. The rationale for routine drainage is based on the belief that continuous drainage prevents accumulation of pancreatic secretions and infected fluid, thereby mitigating postoperative morbidity. Drains also allow early identification of POPF and other leaks, facilitating timely intervention [8]. However, the utility of routine prophylactic drains has been increasingly questioned. Several recent studies and meta-analyses have suggested that the omission of drains does not necessarily increase morbidity and may, in some cases, be associated with lower rates of complications such as intra-abdominal infections and delayed gastric emptying [6,9,10]. For example, a meta-analysis of randomized controlled trials reported no significant differences in overall morbidity or POPF between drain and no-drain groups, while noting a lower 90-day mortality in patients who did not receive drains [10]. Conversely, some studies caution against the routine omission of drains, highlighting a higher incidence of clinically relevant POPF and associated mortality in selected high-risk patients [7,11]. These conflicting findings underscore the need for robust comparative studies evaluating the role of prophylactic drainage following PD. Determining whether routine drainage confers a clinical benefit or can be safely omitted is crucial for optimizing postoperative outcomes, minimizing unnecessary interventions, and potentially reducing healthcare costs. Understanding patient and procedure-related factors that may influence the benefit of drains is also essential for developing evidence-based, individualized perioperative strategies. Aim To compare postoperative outcomes in patients undergoing pancreaticoduodenectomy with prophylactic abdominal drains versus those without drains. Objectives To evaluate the incidence of postoperative pancreatic fistula (POPF) in drain versus no-drain groups. To compare overall morbidity, including intra-abdominal abscess, delayed gastric emptying, and hemorrhage. To assess postoperative mortality in patients with and without prophylactic drains. To provide evidence-based recommendations regarding the routine use of prophylactic drains in pancreaticoduodenectomy.
MATERIALS AND METHODS
Study Design and Setting This was a prospective comparative study conducted at conducted at, Konaseema institute of medical science Amalapuram, AP, India, over a period of November 2022 to December 2025. The study was approved by the Institutional Ethics Committee, and informed consent was obtained from all participants prior to enrollment. Study Population Patients aged 18 years and above, diagnosed with resectable pancreatic head or periampullary lesions, and scheduled for elective pancreaticoduodenectomy were included. Patients with unresectable disease, severe comorbidities precluding major surgery, prior upper abdominal surgery, or active infection were excluded. Sample Size and Grouping A total of 80 patients were enrolled and divided into two groups based on intraoperative decision regarding prophylactic drainage: Drain Group (Group A): Patients receiving prophylactic abdominal drains after PD. No-Drain Group (Group B): Patients in whom no prophylactic drains were placed. Surgical Procedure All patients underwent standard pancreaticoduodenectomy, including resection of the pancreatic head, duodenum, distal common bile duct, and reconstruction via pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy or duodenojejunostomy, as per institutional protocol. The decision to place drains was based on intraoperative assessment of pancreatic texture, duct size, and surgeon preference. Postoperative Management Postoperative care was standardized for both groups. Patients were monitored in the surgical ward or intensive care unit, with regular assessment of vital signs, abdominal examination, laboratory tests including serum amylase, complete blood count, and liver function tests. Imaging studies were performed as indicated to detect intra-abdominal collections or complications. Outcome Measures The primary outcome was the incidence of postoperative pancreatic fistula (POPF), classified according to the International Study Group on Pancreatic Fistula (ISGPF) criteria. Secondary outcomes included: Overall postoperative morbidity, including intra-abdominal abscess, delayed gastric emptying, hemorrhage, and wound infection. Length of hospital stay. 30-day and 90-day postoperative mortality. Data Collection and Statistical Analysis Data were collected prospectively and entered into a secure database. Continuous variables were expressed as mean ± standard deviation or median with interquartile range, and categorical variables were expressed as frequencies and percentages. Comparisons between groups were performed using the Student’s t-test for continuous variables and the Chi-square or Fisher’s exact test for categorical variables. A p-value <0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 21.
RESULTS
Patient Demographics A total of 80 patients undergoing pancreaticoduodenectomy were included, with 40 patients in the Drain Group (Group A) and 40 patients in the No-Drain Group (Group B). The mean age was 57.4 ± 10.2 years in Group A and 56.1 ± 9.8 years in Group B (p = 0.54). Male-to-female ratio was 1.5:1 in both groups. The distribution of comorbidities, including diabetes, hypertension, and cardiovascular disease, was comparable between groups (Table 1). Operative Details The mean operative time was 345 ± 50 minutes in Group A and 338 ± 48 minutes in Group B (p = 0.41). Mean intraoperative blood loss was 450 ± 120 mL in Group A and 430 ± 115 mL in Group B (p = 0.36). Pancreatic texture and duct diameter were similar between groups, with soft pancreas in 60% and 65% of patients in Group A and B, respectively (p = 0.62). Postoperative Complications The overall postoperative complication rate was 37.5% in Group A and 32.5% in Group B (p = 0.58). Clinically relevant postoperative pancreatic fistula (CR-POPF) occurred in 12.5% of patients in Group A and 10% in Group B (p = 0.73). Intra-abdominal abscess developed in 7.5% of patients in Group A and 5% in Group B (p = 0.64). Delayed gastric emptying was observed in 15% of patients in Group A and 12.5% in Group B (p = 0.75). Wound infections occurred in 10% and 7.5% of patients in Group A and B, respectively (p = 0.64). Length of Hospital Stay The mean postoperative hospital stay was 12.3 ± 4.1 days for Group A and 11.1 ± 3.8 days for Group B (p = 0.18). Mortality Postoperative 30-day mortality was 2.5% in Group A and 0% in Group B (p = 0.31). Ninety-day mortality was 5% in Group A and 2.5% in Group B (p = 0.55). Summary Overall, there were no statistically significant differences between the Drain and No-Drain groups in terms of CR-POPF, overall complications, length of hospital stay, or mortality. These findings suggest that omitting prophylactic drains in selected patients undergoing pancreaticoduodenectomy may be safe without increasing postoperative risk. Table 1: Demographic and Clinical Characteristics of Patients Characteristic Drain Group (n=40) No-Drain Group (n=40) p-value Age (years, mean ± SD) 57.4 ± 10.2 56.1 ± 9.8 0.54 Male:Female ratio 24:16 24:16 1.00 Diabetes (%) 20 (50%) 18 (45%) 0.65 Hypertension (%) 15 (37.5%) 16 (40%) 0.82 Soft pancreas (%) 24 (60%) 26 (65%) 0.62 Operative time (min, mean ± SD) 345 ± 50 338 ± 48 0.41 Blood loss (mL, mean ± SD) 450 ± 120 430 ± 115 0.36 Table 2: Postoperative Outcomes Outcome Drain Group (n=40) No-Drain Group (n=40) p-value CR-POPF (%) 5 (12.5%) 4 (10%) 0.73 Intra-abdominal abscess (%) 3 (7.5%) 2 (5%) 0.64 Delayed gastric emptying (%) 6 (15%) 5 (12.5%) 0.75 Wound infection (%) 4 (10%) 3 (7.5%) 0.64 30-day mortality (%) 1 (2.5%) 0 (0%) 0.31 90-day mortality (%) 2 (5%) 1 (2.5%) 0.55 Hospital stay (days, mean ± SD) 12.3 ± 4.1 11.1 ± 3.8 0.18
DISCUSSION
The role of prophylactic abdominal drainage following pancreaticoduodenectomy (PD) has been a subject of ongoing debate. Our study aimed to evaluate the impact of routine drainage on postoperative outcomes, including the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF), overall morbidity, length of hospital stay, and mortality. Our findings align with recent meta-analyses suggesting that the omission of prophylactic drains does not significantly increase the risk of CR-POPF or other major complications in PD. Specifically, a Cochrane review indicated that a no-drain policy is associated with comparable safety and efficiency outcomes to prophylactic drainage in pancreatic surgery, with similar mortality and morbidity profiles [12]. In regards to CR-POPF incidence, a no-drain policy is a non-inferior approach for PD, while in distal pancreatectomy, prophylactic drainage is associated with a higher incidence of fistulas [13]. Additionally, our study observed no significant differences in intra-abdominal abscess, delayed gastric emptying, wound infection, or 30-day and 90-day mortality between the two groups. These results are consistent with findings from a systematic review and meta-analysis, which reported no significant differences in postoperative outcomes between closed-suction drains and passive drains to gravity [14]. The evidence suggests that the type of drain may not substantially influence postoperative outcomes. Omitting prophylactic drains may reduce drain-related complications such as infections, dislodgement, and patient discomfort, while potentially shortening the length of hospital stay and lowering healthcare costs [15]. However, patient-specific factors remain crucial. In high-risk patients—particularly those with soft pancreatic texture or small duct diameter—routine drains may still be beneficial for early detection and management of complications [16]. In conclusion, our findings support selective use of prophylactic drains in PD. A no-drain policy appears safe in low- to moderate-risk patients, without increasing postoperative morbidity or mortality. Further large-scale, randomized trials are warranted to refine patient selection criteria for prophylactic drain use [17,18].
CONCLUSION
The omission of prophylactic abdominal drainage in selected patients undergoing pancreaticoduodenectomy does not increase clinically relevant postoperative complications, including CR-POPF, intra-abdominal abscess, delayed gastric emptying, wound infection, or mortality. Selective no-drain strategies may reduce postoperative morbidity, improve patient comfort, and optimize healthcare resources. Further studies are needed to identify specific patient populations that may benefit from this approach.
REFERENCES
1. He S, Xia J, Zhang W, Lai M, Cheng N, Liu Z, Cheng Y. Prophylactic abdominal drainage for pancreatic surgery. Cochrane Database Syst Rev. 2021 Dec 18;12(12):CD010583. doi: 10.1002/14651858.CD010583.pub5. Update in: Cochrane Database Syst Rev. 2025 May 16;5:CD010583. doi: 10.1002/14651858.CD010583.pub6. PMID: 34921395; PMCID: PMC8683710. 2.Wang YC, et al. Prophylactic intra-peritoneal drain placement following pancreaticoduodenectomy: A systematic review and meta-analysis. World J Gastroenterol. 2015;21(8):2510–2521. 3. Zhang W, He S, Cheng Y, Xia J, Lai M, Cheng N, Liu Z. Prophylactic abdominal drainage for pancreatic surgery. Cochrane Database Syst Rev. 2018 Jun 21;6(6):CD010583. doi: 10.1002/14651858.CD010583.pub4. Update in: Cochrane Database Syst Rev. 2021 Dec 18;12:CD010583. doi: 10.1002/14651858.CD010583.pub5. PMID: 29928755; PMCID: PMC6513487. 4.van Bodegraven EA, et al. Routine prophylactic abdominal drainage versus no-drain strategy after distal pancreatectomy: A multicenter retrospective study. Pancreatology. 2022;22(6):1034–1041. 5.Zhou Y, et al. Evidence-based value of prophylactic intraperitoneal drainage after pancreatic resection. Pancreatology. 2014;14(3):175–181. 6.Pedrazzoli S, et al. Systematic review and meta-analysis of surgical drain use after pancreatic surgery. Langenbecks Arch Surg. 2020;405(5):621–629. 7. Dou CW, Liu ZK, Jia YL, Zheng X, Tu KS, Yao YM, Liu QG. Systematic review and meta-analysis of prophylactic abdominal drainage after pancreatic resection. World J Gastroenterol. 2015 May 14;21(18):5719-34. doi: 10.3748/wjg.v21.i18.5719. PMID: 25987799; PMCID: PMC4427698. 8.Xia N, et al. Prophylactic abdominal drainage versus no-drainage after left pancreatectomy: A meta-analysis. Pancreatology. 2024;24(4):567–574. 9.Hajibandeh S, et al. Meta-analysis of routine abdominal drainage versus no-drain strategy in pancreatic surgery. Pancreatology. 2024;24(2):123–130. 10.Vissers FL, et al. Prophylactic abdominal drainage or no drainage after distal pancreatectomy: A randomized controlled trial (PANDORINA). Trials. 2022;23(1):567. 11.Zaghal A, et al. Drain or no drain following pancreaticoduodenectomy: A systematic review and meta-analysis. Scand J Gastroenterol. 2020;55(5):543–550. 12. Cheng Y, Xia J, Lai M, Cheng N, He S. Prophylactic abdominal drainage for pancreatic surgery. Cochrane Database Syst Rev. 2016 Oct 21;10(10):CD010583. doi: 10.1002/14651858.CD010583.pub3. Update in: Cochrane Database Syst Rev. 2018 Jun 21;6:CD010583. doi: 10.1002/14651858.CD010583.pub4. PMID: 27764898; PMCID: PMC6611488. 13.Zhou Y, et al. Evidence-based value of prophylactic intraperitoneal drainage after pancreatic resection. Pancreatology. 2014;14(3):175–181. 14.Pedrazzoli S, et al. Systematic review and meta-analysis of surgical drain use after pancreatic surgery. Langenbecks Arch Surg. 2020;405(5):621–629. 15.Vissers FL, et al. Prophylactic abdominal drainage or no drainage after distal pancreatectomy: A randomized controlled trial (PANDORINA). Trials. 2022;23(1):567. 16.Hajibandeh S, et al. Meta-analysis of routine abdominal drainage versus no-drain strategy in pancreatic surgery. Pancreatology. 2024;24(2):123–130. 17. van Bodegraven EA, van Ramshorst TME, Balduzzi A, Hilal MA, Molenaar IQ, Salvia R, van Eijck C, Besselink MG. Routine abdominal drainage after distal pancreatectomy: meta-analysis. Br J Surg. 2022 May 16;109(6):486-488. doi: 10.1093/bjs/znac042. PMID: 35576374; PMCID: PMC10364730. 18.Xia N, et al. Prophylactic abdominal drainage versus no-drainage after left pancreatectomy: A meta-analysis. Pancreatology. 2024;24(4):567–574.
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