Abstract
BACKGROUND
Previous studies have analyzed the risk factors for complications after ileostomy reversal for rectal cancer (RC), but there were significant differences in the reported risk factors for complications after stoma reversal. No studies have analyzed the risk factors for stoma-related complications and overall postoperative complications separately.
AIM
To analyze the risk factors for overall complications and stoma-related complications after ileostomy reversal for patients with RC.
METHODS
This was a retrospective study of 439 patients who underwent ileostomy reversal at a clinical center and were followed up between September 2012 and September 2022. Continuous variables are expressed as the mean ± SD and were analyzed with independent-sample t tests, while frequency variables are expressed as n (%), and the χ2 test or Fisher’s exact test was used. Univariate and multivariate logistic regression analyses were used to identify predictors of overall complications and stoma-related complications.
RESULTS
The overall complication rate after ileostomy reversal was 11.4%. Patients with lower preoperative albumin concentration (P < 0.01), greater blood loss (P = 0.017), and longer operative times (P < 0.01) were more likely to experience postoperative complications. The incidence of stoma-related complications was 6.4%. Analysis of the study showed that a higher body mass index (BMI) (P < 0.01), preoperative comorbid hypertension (P = 0.049), time from primary surgery to ileostomy reversal (P < 0.01) and longer operation time (P = 0.010) were more likely to result in stoma-related complications postoperatively. Multivariate logistic regression analysis revealed that a lower preoperative albumin level (P < 0.01, OR = 0.888, 95%CI: 0.828-0.958) was an independent risk factor for overall complications. Moreover, multivariate analysis revealed that BMI (P < 0.01, OR = 1.176, 95%CI: 1.041-1.330) and time from primary surgery to ileostomy reversal (P < 0.01, OR = 1.140, 95%CI: 1.038-1.252) were independent risk factors for stoma-related complications after stoma reversal.
CONCLUSION
The preoperative albumin level was a predictor of overall complications. Preoperative BMI and the time from primary surgery to ileostomy reversal were predictors of stoma-related complications.
Keywords: Ileostomy, Reversal, Risk factors, Complications, Rectal cancer
Core Tip: There were no studies that have analyzed the risk factors for stoma-related complications and overall postoperative complications after stoma reversal for rectal cancer (RC) separately. Our study showed that the preoperative serum albumin concentration was a predictor of overall complications. Preoperative body mass index and time between initial surgery and stoma reversal were predictors of stoma-related complications. Therefore, for RC patients undergoing ileostomy reversal, adequate albumin supplementation should be provided preoperatively to reduce the incidence of postoperative complications.
INTRODUCTION
Colorectal cancer (CRC) is a common malignancy that ranks as the third most common cancer and the second leading cause of cancer-related death worldwide[1]. Current treatments for CRC include endoscopic and surgical resection, radiotherapy, immunotherapy, palliative chemotherapy, targeted therapy, extensive surgery, and local ablation of metastases[2-4]. However, with the continuous improvement of surgical techniques, postoperative complications of rectal cancer (RC) are still inevitable, and anastomotic leakage (AL) is one of the most dangerous postoperative complications in RC patients[5-8]. In high-risk resettable RC surgery, temporary ileostomy is often used to reduce the incidence of AL after RC surgery[9-11].
Although protective ileostomy reduced the incidence of AL after RC, the construction of an ileostomy was associated with potential complications, and it reduced the quality of life of patients[12-15]. The overall complication rate of ileostomy is as high as 20%, including dehydration, electrolyte imbalance, parastomal hernia, and peristomal infections, with postoperative bowel obstruction and surgical site infections (SSI) being the most common[16-19]. The risk of complications after stoma reversal can easily reach 17%-20%[20,21], including surgical SSI, AL, intestinal obstruction, postoperative intestinal obstruction, wound dehiscence, extraintestinal leakage and other complications[22,23]. Protective ileostomy was often performed at the expense of the patient’s quality of life[24]. Therefore, correct identification of risk factors for postoperative complications after recovery of the peristomal stoma is necessary.
Previous studies have shown that age, operative time, preoperative comorbid diabetes mellitus and the time from primary surgery to ileostomy reversal are risk factors for complications after ileostomy reversal[25-27]. Li et al[28] reported that early reversal of the ileostomy before 3 months was both practical and safe, allowing sufficient time to recover from the initial resection and soften intra-abdominal adhesions. Ahmadi-Amoli H et al[29] concluded that early reversal of ileostomy was not better than late reversal, and there was no significant difference between the two groups in reducing the risk of stoma complications. There were significant differences in the reported risk factors for complications after stoma reversa and no studies have analyzed the risk factors for stoma-related complications and overall postoperative complications separately.
Based on the results of previous studies, we hypothesized that the time between initial surgery and ileostomy reversal was a risk factor for postoperative complications. The present study was aimed to analyze the risk factors for overall complications and stoma-related complications after ileostomy reversal for RC and to guide clinical practice.
MATERIALS AND METHODS
Patients
This was a retrospective study of 439 patients who underwent ileostomy reversal at a clinical center and were followed up between September 2012 and September 2022. The present study was performed according to the World Medical Association Declaration of Helsinki. Ethical approval from the institutional review board (K2024-002-01) was obtained. All patients signed the informed consent.
Inclusion and exclusion criteria
Patients with RC who underwent laparoscopic low anterior rectal resection with temporary ileostomy and concomitant ileostomy reversal were recruited for this study (n = 548). The exclusion criteria were as follows: (1) Incomplete perioperative medical information (n = 86); and (2) resection of the other organs (n = 23). Ultimately, a total of 439 patients were included in this study (Figure 1).
Figure 1.
Flow chart of patient selection. RC: Rectal cancer.
Criteria for prophylactic ileostomy reversal
The criteria for prophylactic ileostomy reversal were as follows: (1) Regular postoperative follow-up, no new tumor recurrence, or metastasis; (2) satisfactory assessment of anal and rectal function; (3) no anastomotic stenosis, no AL, and no improvement in anastomotic stenosis symptoms; and (4) exclusion of intestinal obstruction and other contraindications to surgery.
Anesthesia management
All patients underwent general intravenous anesthesia in accordance with Chinese anesthesiology guidelines and expert consensus.
Data collection
All clinical information was collected from both inpatient health care systems and outpatient systems. These data included age, sex, body mass index (BMI), smoking status, drinking status, hypertension status, type 2 diabetes mellitus (T2DM) status, hemoglobin level, albumin level, time from primary surgery to ileostomy reversal, operation time, blood loss, length of hospital stay, overall complications, and stoma-related complications.
Statistical analysis
According to the previous literature[20,21], the complication rate of ileostomy reversal is 20%. The significance level was 0.05, the data distribution was 0.10, the permissible error was 0.10, and a two-sided test was performed, which showed that at least 168 patients who underwent ileostomy reversal needed to be included in this study. A total of 439 ileostomy-returned patients were selected for this study, which meant adequate. PASS (version 11) software was used for sample size calculations. Continuous variables are expressed as the means ± SD, and independent-sample t tests were used to analyze the data. Moreover, frequency variables are expressed as n (%), and the χ2 test or Fisher’s exact test was used. A logistic regression model with a backward selection approach was constructed to predict overall complications and stoma-related complications predictors. P < 0.05 was considered to indicate significance. All the data analyses were performed with SPSS (version 22.0).
RESULTS
Clinical characteristics
Overall, 439 RC patients were included in the study (292 males and 147 females). The mean age of the participants was 61.6 ± 11.4 years, and the mean BMI was 22.3 ± 3.0 kg/m2. There were 164 (37.4%) patients with a history of smoking, 144 (32.8%) with a history of drinking, 105 (23.9%) with a history of hypertension, and 42 (9.6%) with a history of T2DM. The mean hemoglobin concentration was 124.7 ± 17.3 g/L, and the mean albumin concentration was 40.5 ± 4.3 g/L. The time from primary surgery to ileostomy reversal was 4.6 ± 2.9 months, the mean operation time was 94.2 ± 41.7 min, the mean blood loss was 29.7 ± 34.5 mL, and the mean hospital stay was 5.7 ± 3.1 days. There was no 30-d mortality. Postoperative complications occurred in 50 (11.4%) patients, and stoma-related complications occurred in 28 (6.4%) patients. The clinical characteristics of the patients in the study groups are summarized in Table 1.
Table 1.
Clinical characteristics of the whole cohort, n (%)
|
Characteristics
|
No. 439
|
| Age (yr) | 61.6 ± 11.4 |
| Sex | |
| Male | 292 (66.5) |
| Female | 147 (33.5) |
| BMI (kg/m2) | 22.3 ± 3.0 |
| Smoking | 164 (37.4) |
| Drinking | 144 (32.8) |
| Hypertension | 105 (23.9) |
| T2DM | 42 (9.6) |
| Hemoglobin (g/L) | 124.7 ± 17.3 |
| Albumin (g/L) | 40.5 ± 4.3 |
| The time from primary surgery to ileostomy reversal (months) | 4.6 ± 2.9 |
| Operation time (min) | 94.2 ± 41.7 |
| Blood loss (mL) | 29.7 ± 34.5 |
| Hospital stay (d) | 5.7 ± 3.1 |
| Overall complications | 50 (11.4) |
| Stoma-related complications | 28 (6.4) |
T2DM: Type 2 diabetes mellitus; BMI: Body mass index.
Statistical analysis of overall complications and stoma-related complications
The overall complication rate after ileostomy reversal was 11.4%. Patients with lower preoperative albumin concentration (P < 0.01), greater blood loss (P = 0.017), and longer operative times (P < 0.01) were more likely to experience postoperative complications (Table 2). The incidence of stoma-related complications was 6.4%. Analysis of the study showed that a higher BMI (P < 0.01), preoperative comorbid hypertension (P = 0.049), time from initial surgery to ileostomy reversal (P < 0.01) and longer operative time (P = 0.010) were more likely to result in stoma-related complications postoperativel (Table 3).
Table 2.
Comparison between the complication group and the no complication group, n (%)
|
Characteristics
|
Complication (50)
|
No complication (389)
|
P value
|
| Age (yr) | 63.2 ± 10.0 | 61.4 ± 11.5 | 0.300 |
| Sex | 0.579 | ||
| Male | 35 (53.2) | 257 (64.0) | |
| Female | 15 (46.8) | 132 (36.0) | |
| BMI (kg/m2) | 22.5 ± 2.7 | 22.3 ± 3.1 | 0.710 |
| Smoking | 20 (35.3) | 144 (39.2) | 0.682 |
| Drinking | 16 (28.5) | 128 (32.6) | 0.898 |
| Hypertension | 10 (26.4) | 95 (24.1) | 0.490 |
| T2DM | 7 (12.8) | 35 (10.2) | 0.258 |
| Hemoglobin (g/L) | 122.6 ± 18.6 | 125.0 ± 17.1 | 0.366 |
| Albumin (g/L) | 38.8 ± 4.0 | 40.8 ± 4.2 | < 0.01a |
| The time from primary surgery to ileostomy reversal (months) | 5.0 ± 3.3 | 4.6 ± 2.8 | 0.369 |
| Operation time (min) | 103.6 ± 43.4 | 93.0 ± 41.4 | 0.090 |
| Blood loss (mL) | 40.7 ± 49.6 | 28.3 ± 31.8 | 0.017a |
| Hospital stay (d) | 9.1 ± 6.0 | 5.3 ± 2.1 | < 0.01a |
P < 0.05.
T2DM: Type 2 diabetes mellitus; BMI: Body mass index.
Table 3.
Comparison between the stoma-related group and the no stoma-related complication group
|
Characteristics
|
Stoma-related Complication (28)
|
No stoma-related complication (411)
|
P value
|
| Age, (yr) | 64.8 ± 10.7 | 61.4 ± 11.4 | 0.133 |
| Sex | 0.277 | ||
| Male | 16 (53.2) | 276 (64.0) | |
| Female | 12 (46.8) | 135 (36.0) | |
| BMI (kg/m2) | 23.8 ± 2.9 | 22.2 ± 3.0 | < 0.01a |
| Smoking | 10 (35.3) | 154 (39.2) | 0.853 |
| Drinking | 8 (28.5) | 136 (32.6) | 0.622 |
| Hypertension | 11 (26.4) | 94 (24.1) | 0.049a |
| T2DM | 4 (12.8) | 38 (10.2) | 0.329 |
| Hemoglobin | 123.9 ± 21.9 | 124.8 ± 17.0 | 0.793 |
| Albumin (g/L) | 39.7 ± 4.0 | 40.6 ± 4.3 | 0.287 |
| The time from primary surgery to ileostomy reversal (months) | 6.3 ± 3.8 | 4.5 ± 2.8 | < 0.01a |
| Operation time (min) | 113.7 ± 60.3 | 92.9 ± 39.5 | 0.010a |
| Blood loss (mL) | 39.6 ± 36.9 | 29.1 ± 34.3 | 0.116 |
| Hospital stay (d) | 5.3 ± 1.7 | 5.7 ± 3.1 | 0.452 |
P < 0.05.
T2DM: Type 2 diabetes mellitus; BMI: Body mass index.
Univariate and multivariate logistic regression analyses of overall complications
Univariate analysis suggested that patients with a lower preoperative albumin concentration (P < 0.01, OR = 0.887, 95%CI: 0.822-0.957) had a greater risk of ileostomy reversal complications, and multivariate analysis suggested that a lower preoperative albumin concentration (P < 0.01, OR = 0.888, 95%CI: 0.828-0.958) was an independent risk factor for overall complications. Other factors, including age, sex, BMI, T2DM status, smoking status, drinking status, hypertension status, hemoglobin, and the time from primary surgery to ileostomy reversal, had no predictive value for overall complications (P > 0.01) (Table 4).
Table 4.
Univariate and multivariate logistic regression analysis of overall complications
|
Risk factors
|
Univariate analysis
|
Multivariate analysis
|
||
|
OR (95%CI)
|
P value
|
OR (95%CI)
|
P value
|
|
| Age (yr) | 1.014 (0.988-1.041) | 0.300 | ||
| Sex (female/male) | 0.834 (0.440-1.583) | 0.579 | ||
| BMI (kg/m2) | 1.019 (0.924-1.122) | 0.710 | ||
| T2DM (yes/no) | 1.647 (0.689-3.934) | 0.262 | ||
| Smoking (yes/no) | 1.134 (0.621-2.071) | 0.682 | ||
| Drinking (yes/no) | 0.960 (0.511-1.803) | 0.898 | ||
| Hypertension (yes/no) | 0.774 (0.373-1.606) | 0.491 | ||
| Hemoglobin (g/L) | 0.992 (0.976-1.009) | 0.365 | ||
| Albumin (g/L) | 0.887 (0.822-0.957) | < 0.01a | 0.888 (0.828-0.958) | < 0.01a |
| The time from primary surgery to ileostomy reversal (months) | 1.042 (0.952-1.141) | 0.371 | 1.030 (0.939-1.130) | 0.534 |
P < 0.05.
T2DM: Type 2 diabetes mellitus; BMI: Body mass index.
Univariate and multivariate logistic regression analyses of stoma-related complications
Univariate analysis revealed that patients with a higher BMI (P < 0.01, OR = 1.175, 95%CI: 1.044-1.324) and a longer time from primary surgery to ileostomy reversal (P < 0.01, OR = 1.142, 95%CI: 1.041-1.253) had a greater risk of postoperative stoma-related complications. Multivariate analysis revealed that BMI (P < 0.01, OR = 1.176, 95%CI: 1.041-1.330) and the time from primary surgery to ileostomy reversal (P < 0.01, OR = 1.140, 95%CI: 1.038-1.252) were independent risk factors for stoma-related complications after stoma reversal. There was no association between age, sex, T2DM status, smoking status, drinking status, hypertension status, hemoglobin, or albumin concentration (Table 5).
Table 5.
Univariate and multivariate logistic regression analysis of stoma-related complications
|
Risk factors
|
Univariate analysis
|
Multivariate analysis
|
||
|
OR (95%CI)
|
P value
|
OR (95%CI)
|
P value
|
|
| Age (yr) | 1.027 (0.992-1.064) | 0.134 | ||
| Sex (female/male) | 1.533 (0.706-3.332) | 0.280 | ||
| BMI (kg/m2) | 1.175 (1.044-1.324) | < 0.01a | 1.176 (1.041-1.330) | < 0.01a |
| T2DM (yes/no) | 1.636 (0.539-4.963) | 0.385 | ||
| Smoking (yes/no) | 0.927 (0.417-2.060) | 0.853 | ||
| Drinking (yes/no) | 0.809 (0.347-1.883) | 0.623 | ||
| Hypertension (yes/no) | 2.182 (0.988-4.820) | 0.054 | ||
| Hemoglobin (g/L) | 0.997 (0.975-1.019) | 0.792 | ||
| Albumin (g/L) | 0.951 (0.867-1.043) | 0.287 | ||
| The time from primary surgery to ileostomy reversal (months) | 1.142 (1.041-1.253) | < 0.01a | 1.140 (1.038-1.252) | < 0.01a |
P < 0.05.
T2DM: Type 2 diabetes mellitus; BMI: Body mass index.
DISCUSSION
In the present study, we found that a lower preoperative albumin, intraoperative hemorrhage, and length of postoperative hospital stay were associated with overall complications after ileostomy. A higher preoperative BMI, preoperative combined hypertension, time from primary surgery to ileostomy reversal, and operative time were associated with stoma-related complications after ileostomy reversal. Pre-operative albumin level was a predictor of overall complications. Preoperative BMI and the time from primary surgery to ileostomy reversal were predictors of stoma-related complications.
Prophylactic ileostomy after low anterior resection is the preferred surgical procedure for patients with resettable and survivable RC, which could reduce the incidence of AL after RC[9-11]. However, the overall complication rate of stoma reversal is as high as 20%, including dehydration, electrolyte imbalance, parastomal hernia, and peristomal infections, with postoperative bowel obstruction and SSI being the most common[16-18]. In our study, postoperative complications occurred in 50 (11.4%) patients, and stoma-related complications occurred in 28 (6.4%) patients; these rates are slightly lower than those previously reported in the literature[30,31].
Studies have shown that hypoalbuminemia negatively affects wound healing and disease severity[32]. In RC surgery, low preoperative protein levels significantly increase the incidence of postoperative complications[33,34]. Similarly, low albumin levels have been associated with postoperative complications in RC patients[35-37]. Our results were similar to those of a previous study showing that low preoperative albumin levels were an independent risk factor for overall complications after ileostomy reversal[30]. Moreover, preoperative albumin levels were not significantly associated with stoma-related complications. This might be related to the fact that the included patients all had normal preoperative albumin values.
Multivariate risk factor analysis revealed that obesity was a risk factor for stoma-related complications. Previous studies have shown that obesity is also a risk factor for AL after resection of RC resection[38], and obese patients are at increased risk of incisional hernia[39]. The postoperative healing process might also be impaired in obese patients due to the impaired visual field in overweight patients and the more complex release of adhesions during ileostomy reversal. Currently, there is no definitive conclusion on the optimal timing of stoma reversal. We found that prolonged time from initial surgery to stoma reversal was an independent risk factor for stoma-related complications, which was similar to the findings of previous studies[15,27].
In this study, we investigated for the first time the risk factors for overall complications and stoma-related complications after stoma reversal for RC. However, our study has several limitations. First, there was a lack of analysis of the long-term prognosis of the patients. Second, there was no categorical analysis of postoperative complications. Third, there was a lack of adequate preoperative baseline information on patients and tumor staging studies. In the future, we hope to collect more clinical information and evaluate more variables through multicenter collaborations.
CONCLUSION
In summary, the preoperative serum albumin concentration was a predictor of overall complications. Preoperative BMI and time between initial surgery and stoma reversal were predictors of stoma-related complications. Therefore, for RC patients undergoing ileostomy reversal, adequate albumin supplementation should be provided preoperatively to reduce the incidence of postoperative complications.
ACKNOWLEDGEMENTS
We acknowledge all the authors whose publications are referred in our article.
Footnotes
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Chongqing Medical University.
Informed consent statement: The requirement for patients' informed consent for this study was waived due to its retrospective nature.
Conflict-of-interest statement: Academic Editor has no conflict of interest.
Provenance and peer review: Unsolicited article; Externally peer reviewed.
Peer-review model: Single blind
Specialty type: Gastroenterology and hepatology
Country of origin: China
Peer-review report’s classification
Scientific Quality: Grade C
Novelty: Grade C
Creativity or Innovation: Grade C
Scientific Significance: Grade C
P-Reviewer: Glumac S, Croatia S-Editor: Qu XL L-Editor: A P-Editor: Zheng XM
Contributor Information
Quan Lv, Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
Xin-Peng Shu, Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
Dong Peng, Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
Si-Qi Li, Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
Zheng Xiang, Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China; Chongqing Key Laboratory of Department of General Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China. doctor13330209937@126.com.
Data sharing statement
The datasets generated and/or analyzed during the current study are not publicly available due but are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated and/or analyzed during the current study are not publicly available due but are available from the corresponding author upon reasonable request.