Transanal drainage tube versus diverting stoma for reducing anastomotic leakage after rectal cancer surgery: a systematic review and meta-analysis

Introduction

While the introduction of total mesorectal excision and neoadjuvant therapy has led to improved oncological outcomes, parallel advancements in surgical techniques, particularly the standardization of stapling methods, have substantially increased sphincter preservation rates (1,2). However, this progress is tempered by the persistent challenge of anastomotic leakage (AL), which remains one of the most frequent and serious complications following low anterior resection. Reported incidence rates vary widely, from 3.4% to 20%, reflecting differences in patient risk factors, surgical expertise, and diagnostic criteria (3,4). The repercussions of AL are profound and multi-faceted. It represents a major clinical and economic burden, directly leading to a prolonged hospital stay, increased need for radiological or surgical re-interventions, and higher in-hospital mortality (5). Beyond the immediate perioperative period, AL has been consistently linked to detrimental long-term oncological outcomes (6), including an increased risk of local recurrence, impaired long-term survival, and a permanent reduction in patients’ quality of life and functional outcomes. Consequently, the effective prevention of AL is not merely a technical goal but a critical determinant of overall surgical success.

In response to this challenge, two principal prophylactic strategies have been widely adopted in clinical practice. The creation of a diverting stoma (DS), typically an ileostomy or colostomy, is considered the traditional and most definitive method (7). By completely diverting the fecal stream, it effectively protects the distal anastomosis or shortens leakage recovery once AL happened (8). As a less invasive stoma-sparing technique, transanal drainage tube (TDT) is designed to decompress the rectum and anastomosis, theoretically reducing intraluminal pressure and facilitating healing without the need for fecal diversion. While appealing in concept, the evidence regarding its efficacy and safety relative to DS has been inconsistent and inconclusive (9,10).

Therefore, a clear and definitive comparison between these two strategies is urgently needed to guide surgical decision-making. To address this pivotal clinical question, we conducted the present systematic review and meta-analysis. Our objective was to comprehensively evaluate and compare the effectiveness of TDT versus DS in reducing AL after rectal cancer surgery, with the aim of providing high-level evidence to inform individualized patient care and clinical practice guidelines. We present this article in accordance with the PRISMA reporting checklist (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2026-1-0053/rc) (11-13).

Methods

Study selection

This systematic review and meta-analysis was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD420251275205). A comprehensive search of PubMed, EMBASE, Web of Science, and the Cochrane Library was performed from inception to December 2025. To identify relevant studies, we employed MeSH terms and keywords including “rectal neoplasms”, “surgical stomas”, and “transanal tube”. The search was limited to English-language publications to maintain consistency in data interpretation and analysis.

Studies were included if they met all the following criteria: (I) enrolled patients who underwent anterior resection for rectal cancer; (II) directly compared the outcomes between patients receiving a TDT and those with a DS after colorectal anastomosis; and (III) reported on the incidence of AL as a primary or key secondary outcome. Studies were excluded for any of the following reasons: (I) involving emergency surgeries; (II) non-human research; (III) being conference abstracts, case reports, reviews, editorials, or letters; (IV) presenting insufficient, overlapping, or duplicate data; or (V) being published in languages other than English.

Data extraction and types of outcomes

The extracted demographic and clinical data included study design, sample size, patient sex and age, tumor or anastomosis distance from the anus, and anastomosis formation method. Given their established correlation with AL, the history of diabetes mellitus and neoadjuvant therapy was also collected. These variables were systematically recorded to comprehensively characterize the included study populations and facilitate cross-study comparison.

The primary outcome of this systematic review was the incidence of AL. When reported, the severity grade of AL was also assessed. Secondary outcomes included other postoperative complications and postoperative length of hospital stay (LOS). Quantitative synthesis was performed for those postoperative complications that were reported consistently across studies, specifically bowel obstruction, bleeding, urinary retention, and wound infection.

Quality assessment

A rigorous assessment of the methodological quality of the included studies was undertaken using validated tools specific to each study design. The original publications and any associated trial registry records were carefully reviewed. For systematic reviews, we employed the 11-item Assessment of Multiple Systematic Reviews (AMSTAR) instrument (14). As all primary studies in our analysis were non-randomized in design, the Newcastle-Ottawa Scale (NOS; range, 0–9 points) was applied for their methodological appraisal, with higher scores representing higher quality (15). Accordingly, studies achieving an NOS score ≥5 were considered to be of high quality and thus eligible for inclusion.

Quality assessment was carried out independently by two investigators (Z.L. and X.Z.). Inter-observer agreement was measured to ensure scoring consistency. All discrepancies were adjudicated by a third reviewer (Z.C.) through a consensus-based discussion. This rigorous methodology was implemented to reduce potential bias and enhance the overall validity of the quality appraisal.

Statistical analysis

Descriptive statistics were used to summarize the demographic and clinical characteristics from the included studies. For data analysis, categorical variables were compared using the Chi-squared test or Fisher’s exact test, as appropriate, while continuous variables were analyzed with standard comparative methods. Upon accumulating sufficient data, we proceeded with the systematic review and meta-analysis. All pooled analyses were conducted using Review Manager software (RevMan, version 5.4), applying a random-effects model to calculate summary effect estimates. For dichotomous data, results were expressed as odds ratios (ORs), while for continuous data, mean differences (MDs) were used. In both cases, the effect estimates were presented alongside their 95% confidence intervals (CIs). Statistical significance was defined as a two-sided P value <0.05 for all hypothesis tests. Between-study heterogeneity was quantitatively assessed using the Cochrane Q test and the I² statistic. In cases where significant heterogeneity was indicated (P for Q test <0.1 or I²>50%), we performed sensitivity or subgroup analyses to investigate potential sources of the variation. Additionally, the potential for publication bias was examined visually using funnel plots (Figure S1).

Results

Study selection and quality assessment

Our comprehensive search of four electronic databases yielded 162 potentially relevant records (Tables S1-S4). After removing duplicates, 99 unique studies proceeded to title and abstract screening. Subsequently, 19 full-text articles were assessed for eligibility, of which seven non-randomized controlled trials met all inclusion criteria and were included in the final systematic review and meta-analysis. The study selection process, detailed in the PRISMA flow diagram (Figure 1), documents reasons for exclusion at each stage. The methodological quality of these seven studies, independently assessed by two investigators using the NOS, is summarized in Table S5. Furthermore, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to evaluate the evidence for the purpose of making specific treatment recommendations (Table S6).

Figure 1 PRISMA selection flow diagram.

Study characteristics

Characteristics of the included seven studies (16-22) are summarized in Table 1, comprising two prospective and five retrospective designs. Collectively, they involved a total of 1,347 patients, with a mean or median age ranging from 60 to 70 years. All patients underwent anterior resection for rectal cancer, with 671 and 676 patients receiving a TDT and a DS, respectively. The reported incidence of AL varied across studies, ranging from 5% to 12%. Notably, there was heterogeneity in the use of neoadjuvant therapy: while none of the patients in the studies by Bülow et al. (16) and Kim et al. (17) received it, all patients in the studies by Pyo et al. (19) and Gordiichuk et al. (20) did.

Primary outcomes

Overall, no significant difference in the risk of AL could be observed between rectal cancer patients who underwent TDT and those who underwent DS across all included studies (OR =0.73, 95% CI: 0.42 to 1.29, P=0.28), encompassing both retrospective (P=0.54) and prospective designs (P=0.79) (Figure 2).

Figure 2 Primary outcome for overall studies. CI, confidence interval; DS, diverting stoma; M-H, Mantel-Haenszel; TDT, transanal drainage tube.

To investigate potential effect modifiers, we performed subgroup analyses based on two key variables, namely AL severity and neoadjuvant therapy status (Figure 3). None of these subgroup analyses revealed a statistically significant difference in AL rates between the TDT and DS groups, with a P value of 0.72 for severe AL (grade B/C), 0.44 for patients receiving neoadjuvant therapy, and 0.89 for those not receiving it.

Figure 3 Subgroup analyses of primary outcome for: (A) grade B/C AL, (B) patients with neoadjuvant therapy, and (C) patients without neoadjuvant therapy. AL, anastomotic leakage; CI, confidence interval; DS, diverting stoma; M-H, Mantel-Haenszel; TDT, transanal drainage tube.

Secondary outcomes

Other postoperative complications and postoperative LOS were also evaluated (Figure 4). Specifically, a significant reduction in the rate of bowel obstruction was observed in the TDT group (OR =0.16, 95% CI: 0.08 to 0.32, P<0.01). Other evaluated outcomes, including postoperative bleeding (P=0.51), urinary retention (P=0.80), wound infection (P=0.89), and LOS (P=0.38), showed no statistically significant difference between the TDT and DS groups.

Figure 4 Secondary outcomes. (A) Bleeding. (B) Bowel obstruction. (C) LOS. (D) Urinary retention. (E) Wound infection. CI, confidence interval; DS, diverting stoma; LOS, length of hospital stay; M-H, Mantel-Haenszel; TDT, transanal drainage tube.

Discussion

The creation of a DS remains one of the most common clinical strategies for preventing AL and reoperation, despite ongoing debate about its efficacy in actually reducing AL incidence (8,23-25). While it may mitigate the severity of AL-related morbidity, the stoma itself is a significant source of complications, leading to prolonged LOS, readmissions, and issues like dehydration (26,27). Stoma-related complications were also documented in three of the included studies in this meta-analysis (17,19,21). These included complications of the stoma itself, such as stenosis, prolapse, necrosis, parastomal hernia, parastomal ulcer, ileostomy leakage, fluid or electrolyte imbalance, and even acute kidney injury or hospital readmission. Furthermore, complications arising specifically from stoma reversal surgery were also reported, including anastomotic leak at the closure site, wound infection, wound dehiscence, ileus, and incisional hernia. Compounding this issue, stoma reversal fails in 6% to 40% of cases, resulting in unintended permanent stomas (28,29). All these significant drawbacks profoundly impact body image and quality of life. As a stoma-sparing alternative intended to avoid these burdens, the TDT has been increasingly adopted. Although prior studies have suggested its potential utility in preventing AL (30,31), a direct and comprehensive synthesis comparing TDT to the standard DS has been lacking. This evidence gap has contributed to clinical equipoise in surgical decision-making. Our study addresses this need by providing a systematic review and meta-analysis, demonstrating that TDT offers equivalent protection against AL while eliminating stoma-related morbidity and the need for reversal surgery. This evidence could directly inform and optimize surgical strategy. Notably, Wang et al. (22) further reported earlier exhaust time and lower total costs in the TDT group. However, these outcomes could not be included in the meta-analysis due to insufficient data or inconsistent reporting across other studies.

It is noteworthy that the protective effect against AL may vary with the type and indwelling duration of the TDT. Luo et al. (32) compared three TDT variants, differing in material and size, and found that while an Fr32 silicone tube led to significantly earlier first defecation compared to Fr24 silicone or latex tubes, there was no significant difference in the incidence of AL, abdominal distension, or time to first flatus among the three types. Separately, Xu et al. (33) systematically investigated indwelling time, reporting that TDT placement for more than five days was associated with significantly reduced rates of AL and overall reoperation compared to no TDT use; however, no such benefits were observed when the indwelling time was less than five days. These findings collectively suggest that a larger-bore tube and a longer indwelling period might yield better outcomes. Nevertheless, these potential benefits must be balanced against the possibility of increased patient discomfort, which could impair compliance (e.g., reluctance to mobilize or participate in other therapies), highlighting an area requiring further evaluation.

The protective effect of the TDT on the anastomosis, however, remains contentious. A randomized trial by Zhao et al. (9) found no benefit for AL prevention in laparoscopic low anterior resection for mid-low rectal cancer, a finding echoed in several retrospective series (34-36). Due to inherent limitations such as retrospective design, small sample sizes, and non-concurrent controls, the overall evidence grade for TDT efficacy is currently low. Furthermore, selective use in high-risk patients may confound outcomes and contribute to unreliable estimates of its effect. Therefore, despite the theoretical and practical advantages of TDT over a DS, robust, high-level evidence from well-designed trials is urgently needed to definitively establish its effectiveness.

Beyond its preventive role, the TDT also holds therapeutic value in managing AL, particularly in patients who already have a DS. Supporting this, Shalaby et al. (37) reported a series of rectal cancer patients with subclinical AL following ultralow anterior resection and DS creation, who were successfully treated with a combination of endoscopically placed TDT and intravenous antibiotics, achieving complete anastomotic healing without stenosis. This finding underscores that TDT provides a safe, cost-effective, and efficacious treatment option for AL. Crucially, this anastomosis-salvaging approach can potentially obviate the need for a permanent Hartmann’s colostomy, significantly altering the patient’s long-term outcome.

Beyond the comparative efficacy in prevention, the value of TDT may be further amplified when considering a comprehensive postoperative management strategy. This flexibility is particularly relevant in an era emphasizing enhanced recovery after surgery (ERAS) protocols. The potential for earlier recovery of bowel function and reduced hospitalization costs associated with TDT, as noted in some studies, aligns with ERAS goals of minimizing physiological stress and accelerating patient mobilization. Therefore, the decision-making calculus extends beyond a simple binary comparison of leak rates. Instead, it should integrate the potential of TDT to streamline postoperative care, reduce stoma-related burdens on quality of life, and offer a salvage option should a leak occur, thereby potentially reducing the escalation to more radical surgical interventions.

The translation of these synthesized findings into clinical practice necessitates careful consideration of patient selection and technical standardization. While our meta-analysis provides evidence for equipoise in AL prevention between TDT and DS, it concurrently identifies a clear advantage for TDT in reducing bowel obstruction. This suggests that for patients at lower risk for AL but potentially higher risk for postoperative ileus or those with a strong preference to avoid stoma, TDT presents a compelling alternative. Future research should pivot towards developing validated risk stratification models that can guide personalized selection of prophylactic measures. Furthermore, to harness the full potential of TDT, efforts must concentrate on standardizing its application, defining optimal tube characteristics, indwelling duration, and placement protocols, through rigorously designed, multicenter prospective studies or randomized trials that specifically address the current limitations of the evidence base.

An important consideration when interpreting our findings is the potential variability in the definition and diagnosis of AL across the included studies. Although the International Study Group of Rectal Cancer (ISGRC) grading system has been widely adopted, earlier studies such as Bülow et al. used less standardized definitions, and others differed in diagnostic timing or methods (e.g., routine contrast enema vs. imaging on clinical suspicion). Importantly, all studies consistently captured clinically relevant AL requiring therapeutic intervention (equivalent to ISGRC grades B/C), which was our primary outcome. Therefore, while definitional heterogeneity exists, the core endpoint remains comparable across studies. Future research should adopt standardized reporting to facilitate more precise comparisons.

Despite the rigorous methodology, our findings are subject to several key limitations stemming from the available evidence. First, although all included studies were assessed using the NOS and indicating moderate quality, it may not fully capture confounding by indication. In clinical practice, surgeons preferentially select DS for higher-risk patients, likely overestimating the protective effect of TDT. This bias was evident in studies where DS groups had lower tumor height, higher neoadjuvant therapy rates, longer operative time, or greater blood loss. Only Pyo et al. used propensity score matching to adjust for confounding. The RCT by Bülow et al. was terminated early, and 22% of TDT patients deviated from the intended intervention. For secondary outcomes, low event counts led to imprecise estimates. Based on the GRADE assessment, the certainty of evidence ranged from moderate to very low. Second, significant clinical heterogeneity was present, most notably in the inconsistent application of neoadjuvant therapy (0% to 100% across studies) and variable reporting of TDT specifications, which precluded subgroup analyses on these critical technical factors. Third, while the overall heterogeneity was low, certain subgroup analyses (e.g., prospective studies, I²=85%) were underpowered and produced imprecise estimates. Additionally, restricting the search to English-language publications may have introduced language bias, potentially excluding relevant studies published in other languages. Finally, the observational nature of all included studies precludes definitive causal conclusions regarding the equivalence of TDT and DS. Therefore, results of this study should be interpreted with caution, and future prospective trials with standardized protocols are essential to confirm these findings.

Conclusions

This systematic review and meta-analysis indicates that no significant difference was observed between TDT and DS in reducing AL after anterior resection for rectal cancer. Notably, TDT use was associated with a significantly lower incidence of postoperative bowel obstruction. Given these findings, TDT may be considered a viable option for carefully selected patients, particularly those seeking to avoid stoma-related complications and the need for a second reversal surgery. Clinical decision-making should remain individualized, weighing the absence of a significant difference in AL rates against the potential benefit of reduced obstruction risk.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2026-1-0053/rc

Peer Review File: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2026-1-0053/prf

Funding: This study was supported by the Foshan City Self-Funded Science and Technology Innovation Project (grant No. 2420001004208).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2026-1-0053/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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