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Does an Ileostomy Rod Prevent Stoma Retraction? A Meta-analysis of Randomized Controlled Trials

Empirical Studies

Does an Ileostomy Rod Prevent Stoma Retraction? A Meta-analysis of Randomized Controlled Trials

Index: Wound Management & Prevention 2020;66(1):24–29 doi: 10.25270/wmp.2020.1.2429

Abstract

A rod passed through the mesenteric window is commonly used during maturation of ileostomies, but evidence for the effectiveness of this procedure is limited.

PURPOSE. The aim of this meta-analysis was to determine whether ileostomy rods decrease stoma retraction rates in patients undergoing loop ileostomy (LI). METHODS: The PubMed, EMBASE, Cochrane Library, MEDLINE via Ovid, Cumulative Index of Nursing and Allied Health Literature, and Web of Science databases were systematically searched for randomized controlled trials (RCT) published in English from 1990 to the present date using the MeSH terms ostomy, rod, and bridge to compare ileostomies with a rod to those without a rod. Study information, patient demographics, characteristics, and stoma retraction rates were abstracted. The primary endpoint, stoma retraction, was defined as the disappearance of normal stomal protrusion to at, or below, skin level. The Mantel-Haenszel method of meta-analysis with odds ratio and 95% confidence interval (OR [95% CI]) was used. Among-study statistical heterogeneity was assessed using Cochrane chi-squared and I2 tests. Tau2 analysis to assess between-study variance was employed when I2 was greater than 50%. The number needed to treat/harm (NNT) was calculated to assess clinical relevance of any statistical difference. Visual assessment of funnel plots and Egger’s test were used to assess for publication bias. RESULTS: Of the 228 publications identified, 3 RCTs totaling 392 patients (194 LI with rod and 198 LI without rod) met the inclusion criteria for analysis. Overall bias risk was low. The stoma retraction rate was 3.1% (6/194) in patients with a rod versus 4.5% (9/198) in patients with LI without a rod at a mean follow-up of 3 months. This difference was not statistically or clinically significant (OR [95% CI] = 0.60 (0.21-1.72); P = .34; NNT = 69), with low statistical heterogeneity noted among the studies (I2 = 0%). CONCLUSION: This meta-analysis found that ileostomy rods do not decrease stoma retraction rates at 3-month follow-up. Studies examining the rate of all potential complications in patients who do and do not receive rod placement following IL are needed to help surgeons make evidence-based decisions.

Introduction

Widespread use of ileostomy creation came as a result of the work of John Y. Brown in 1911.1 Before the 1940s, undergoing the creation of an ileostomy was a traumatic event; because there were no appliances, the ileum was brought out several inches with a decompression tube.2 In 1941, clinicians suggested ileostomies should have a split-thickness skin graft placed on the externalized bowel to prevent peristomal dermatitis.3 The concept of the everted ileostomy, suturing the mucosa to the skin, was established in 1952.4 Moreover, ileostomies are commonly matured over a rod passed through the same mesenteric window utilized to exteriorize the ileum and secured with tape. The rod can be removed as soon as enough edema has developed to maintain the exteriorized intestine. Nonetheless, it has been common practice to leave the rod in situ for an arbitrary number of days or even weeks, although a number of observational studies5 have expressed concern about the difficulty of managing an appliance with a rod in place and that the rod itself can constitute an element of obstruction that interferes with recovery. A prospective cohort study6 demonstrated that an ostomy rod may be associated with increased time for ostomy care as well as a higher number of stoma appliance changes, thereby increasing costs. 

A potential advantage of using an ileostomy rod to prevent stoma retraction (which complicates up to 22% of loop ileostomies [LIs]) is counterbalanced by a potentially increased risk of local stoma complications such as peristomal dermatitis and stoma necrosis.5 The decision to conduct this study was prompted by the mixed nature of existing evidence and the need for a critical appraisal of the role of ileostomy rods in decreasing the risk of stoma retraction. The aim of this systematic review and meta-analysis was to determine whether ileostomy rods lead to decreased stoma retraction rates.

Materials and Methods

This systematic review and meta-analysis was performed according to the Cochrane Handbook for Systematic Reviews of Interventions7 and follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)8 and Assessing the Methodological Quality of Systematic Reviews (AMSTAR 2) guidelines.9 The protocol for this systematic review was prospectively registered in the International Prospective Register of Systematic Reviews (PROSPERO): CRD42018086635. The literature search, quality assessment, and data extraction and analysis, along with the critical appraisal, were performed by 2 independent researchers. Any disagreements occurring during the process, such as discrepancy between the assessment results provided by the 2 independent researchers, were discussed and resolved by the senior authors. The research question was formulated within the Patient Population, Intervention, Comparator, Outcomes, Timing, Setting (PICOTS) framework as follows:

(P) Population: Adults older than 18 years old undergoing surgery for LI;

(I) Intervention: LI with rod;

(C) Comparator: LI without rod;

(O) Outcomes: Stoma retraction rate;

(T) Time: 3 months postoperatively; and

(S) Setting: In- and outpatient.

Procedure. The PubMed, EMBASE, Cochrane Library, MEDLINE via Ovid, Cumulative Index of Nursing and Allied Health Literature, and Web of Science databases were systematically searched for randomized controlled trials (RCT) published in English from 1990 to the present using the MeSH terms ostomy, rod, and bridge combined with the Boolean operator AND and all synonyms combined with the Boolean operator OR. In addition, clinicaltrials.gov was searched for any ongoing studies. Relevant articles were identified and the results of the search were screened through the title, abstract, and/or full text article. The sensitivity of the search strategy was tested by screening the references of included articles for additional publications. 

The articles included in this review compared creation of a LI with a rod to ileostomy without a rod in patients undergoing elective colorectal resections. Exclusion criteria were comparative observational studies, noncomparative descriptive studies, technical reports, studies involving pediatric populations, and studies comparing any of the interventions of interest to an irrelevant intervention, such as a skin bridge. 

Ileostomy with a rod was defined as a LI matured over a supporting rigid plastic rod passed through a mesenteric window. Stoma retraction was defined as the disappearance of normal stomal protrusion to at, or below, skin level. The primary endpoint was stoma retraction rate. 

Collected data included author, year of publication, study design, sample size, rates of postoperative adverse events, including the rates of stoma retraction, stoma necrosis, parastomal dermatitis, and parastomal hernia. Quality assessment of each individual study was performed according to the Cochrane Risk of Bias Tool7 on the following items: selection, performance, detection, attrition, selective reporting, and other bias risks. High risk of selection bias was defined as any situation negatively influencing random sequence generation and allocation concealment. Performance bias risk was high when patients and surgeons were not blinded. Not blinding outcomes assessors increases the risk of detection bias. Attrition bias risk was high when authors reported incomplete outcome data and reporting bias risk was present in cases of selective reporting. Levels of evidence of the included studies were defined according to the classification of the Oxford Center for Evidence-Based Medicine (CEBM).10

Data collection and analysis. The data from the included articles were collected to predefined Microsoft Excel (Excel 2010; Microsoft, Redmond, Washington) tables, and studies were assessed for external validity based on the above-mentioned quality assessment by 2 researchers independently.

Inverse variance and Mantel-Haenszel methods of meta-analysis were used for continuous and dichotomous variables, respectively. For continuous variables, the point estimate for standardized mean difference and standard error were calculated; odds ratios (OR) with 95% confidence intervals (CI) were calculated for dichotomous variables. Statistical heterogeneity among effect estimates was assessed using Cochran chi-squared and I2, and between-study variance was assessed using Tau2 statistic when the I2 was 50% or greater.9 A fixed-effects model was utilized for meta-analysis. 

The results of the meta-analysis were illustrated on forest plots. The number needed to treat/harm (NNT) was calculated to assess clinical relevance of any statistical difference. Funnel plots (visual assessment of symmetry) and Egger’s tests were utilized to evaluate for publication bias. A P value <.05 was considered statistically significant. Statistical analysis was performed using RevMan (version 5.3; Nordic Cochrane Center, Cochrane Collaboration, Copenhagen, Denmark) and CMA Software, version 3 (Biostat, Englewood, New Jersey).

Results

Literature search and study selection. Details of study selection are presented in the PRISMA flowchart (see Figure 1). The 6 databases searched revealed 226 records. An additional 2 articles were found through the references of eligible studies. After removal of duplicates, remaining 90 records were screened through the title and the abstract; 68 irrelevant records were excluded and 22 records were screened through full-text articles. After full-text articles were screened for eligibility, 18 studies were excluded: 5 were observational studies, 5 were letters to the editor, 4 were technical notes, and the remaining 4 employed different technique. Four articles11-14 were included for qualitative synthesis, but 1 was excluded11 because colostomy was not the procedure of interest in this meta-analysis.    

Studies included for analysis. From the 22 potentially eligible studies, 3 were analyzed12-14 and included 392 patients (194 LI with a rod and 198 LI without a rod). The characteristics of the included studies are provided in Table 1. All studies were RCTs (Center for Evidence-Based Medicine level of evidence 1b); only 1 was supported by an educational grant.12 All studies included patients with both benign and malignant disease. Patients with a loop colostomy were not included in any of the 3 RCTs. 

The different rods were used in the research (see Table 1). Commercially available rods were used in 2 studies,12,14 and a self-made rod, created by placing a 6 cm K-wire inside an 8 Fr Nelaton’s catheter, was used in the third study. LI rods were removed on postoperative day 7 or 8 in 2 RCTs,12,13 whereas in the remaining study13 LI rod removal time was at the discretion of stoma nurse (see Table 1). The length of follow-up was 3 months in all included RCTs.

Quality assessment. The risk of bias summary and graph of the included studies are presented in Figure 2. Levels of evidence according to the Oxford CEBM provided by each included study are presented in Table 1. Random sequence generation and allocation concealment to prevent selection bias was provided in all included RCTs.12-14 Attrition, reporting, and other bias risks as determined by the Cochrane Quality Assessment Tool, were low in all studies.

Meta-analysis. Stoma retraction rate was reported in all studies (194 LI with rod and 198 LI without rod).12-14 Statistical heterogeneity among the studies was low (I2 = 0%).  A fixed effects model of meta-analysis was utilized. Stoma retraction rate was 3.1% (6/194) in LI with a rod versus 4.5% (9/198) in LI without a rod. This difference was not statistically or clinically significant (OR [95%CI] = 0.60 [0.21-1.72]; P = .34; NNT = 69) (see Figure 3). 

Sensitivity analysis and publication bias. A sensitivity analysis was performed by excluding the studies with the highest risk of bias. This did not affect the findings. Publication bias risk was evaluated by visual assessment of symmetry on the funnel plot (see Figure 4) and using Egger’s test (t = 0.40; 2-tailed P = .73) and was found to be low. 

Discussion

The ambiguity surrounding the use of rods in maturing LIs is perpetuated by the assumption that rods may decrease the risk of retraction, as well as by the challenges posed by using the rods in postoperative ostomy care. The size, shape, and elasticity of an ileostomy rod previously were reported in a prospective cohort study15 (N = 33) to influence outcomes, such as pressure necrosis, ease of appliance use, and parastomal dermatitis. The study15 concluded that the adoption of a ring-shaped ostomy rod was associated with decreased rate of pressure ulcers, shorter time for stoma care, decreased number of required appliances, and reduced cost. The primary research question in this meta-analysis was whether an ileostomy rod is required at all to prevent stoma retraction. The main finding of this meta-analysis is that the addition of rods does not decrease stoma retraction rates at 3-month follow-up. 

Stoma necrosis. Stoma necrosis may occur as a result of increased tension of the mesentery with decreased tissue perfusion that leads to bowel ischemia in patients with an ostomy rod, as well as direct erosion of the bowel wall by an ostomy rod. In the authors’ opinion, ileostomy rods seem to be associated  with increased rates of stoma necrosis and peristomal dermatitis, even though quantitative synthesis of data was not possible due to inconsistent reporting in the included studies. In fact, 1 of the RCTs13 included in this meta-analysis showed significantly increased stoma necrosis rates with ileostomy rod use (30% vs 3%). An RCT11 involving patients undergoing loop colostomy found a similar difference (11% vs 1%; P = .02) favoring ostomies without a rod. A prospective cohort study16 involving 515 patients reported increased peristomal dermatitis rates following creation of an ostomy with rod and concluded that routine ostomy rod usage cannot be recommended, similar to the conclusion by Uchino et al.13 

Peristomal skin irritation. Peristomal skin irritation may be the result of the fact that ileostomy rods may prevent creation of an adequate seal and may lead to effluent leakage and subsequent skin erosion. A prospective cohort study17 (N = 32) reported significantly improved stoma-related quality of life in patients who underwent LI without a rod, with no difference in stoma retraction rates, concluding that ostomy rod is unnecessary and inconvenient to patients. The authors recommended early removal of the ileostomy rod without fear of increasing the risk of stoma retraction. 

Although routine placement of an ileostomy rod may appear to be innocuous and even beneficial, the time and attention given to the technical details of stoma formation can make a major difference to a patient, as was previously stated and confirmed by this meta-analysis.5,14 

Regardless of a use or nonuse of an ostomy rod, stoma retraction may result from tension on the exteriorized bowel wall through the mesentery. As reported previously in summary design articles and a prospective audit of 97 patients, high body mass index18,19 and overaggressive postoperative fluid resuscitation20 may further contribute to the risk of stoma retraction. Moreover, patient factors leading to impaired wound healing such as diabetes and smoking are additional contributing factors. 

Limitations

This meta-analysis has limitations. Two (2) of the 3 included RCTs involved a small number of patients. Despite their experimental design, all RCTs were subject to a high risk for performance bias due to the impracticability of blinding surgeons. Moreover, all studies reported a short-term follow-up duration of 3 months. Longitudinal data may allow researchers to evaluate whether a correlation exists between ostomy rod use and late stoma complications, such as stricture of the stoma and parastomal hernia. Also, ambiguity was noted in the definition of stoma retraction, ranging from less than 5 mm above the skin to more than 5 mm below the skin, a fact that might have over- or underestimated stoma retraction rates. An overall lack of details in reporting other stoma-specific complications was a common limitation of 2 studies.

This meta-analysis suggested that ileostomy rods are not recommended in patients undergoing LI, provided no obvious mechanical (eg, inadequate mobilization of the bowel, obesity, foreshortened mesentery) or systemic (eg, immunodeficiency, impaired wound healing) risk factors are present. However, no such evidence exists regarding the impact of ostomy loop usage on the outcomes of loop colostomy. Further studies are required to determine the impact of ileostomy rod on other stoma-specific complications including peristomal dermatitis, stoma necrosis, prolapse, stricture, and skin necrosis. 

Conclusions

This meta-analysis involving 3 randomized trials totaling 392 patients found that ileostomy rods do not decrease stoma retraction rates in immunocompetent patients undergoing LI without traction. However, there is no evidence as to whether an ostomy without a rod can be used in patients with mechanical and/or systemic risk factors for stoma retraction as well as in loop colostomies. For future research, standardization of the procedure and reporting other stoma-related complications such as stoma necrosis and peristomal skin irritation are necessary to improve the existing evidence on LI rods.

Affiliations

Dr. Gachabayov is a research scholar, Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY. Dr. Tulina is an Associate Professor, Clinic of Colorectal and Minimally Invasive Surgery; and Dr. Tsarkov is Professor of Surgery and Director, Clinic of Colorectal and Minimally Invasive Surgery, Sechenov First Moscow State Medical University, Moscow, Russia. Ms. Weber is an enterostomal therapy nurse; Dr. Lee and Dr. Kajmolli are surgery residents; and Dr. Bergamachi is Professor of Surgery and Chief, Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College. Please address correspondence to: Roberto Bergamaschi, MD, PhD, FRCS, FASCRS, FACS, Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Taylor Pavilion, Suite D-361, 100 Woods Road, Valhalla, NY 10595; email: rcmbergamaschi@gmail.com