Published online Mar 15, 2025. doi: 10.4251/wjgo.v17.i3.102604
Revised: December 22, 2024
Accepted: January 3, 2025
Published online: March 15, 2025
Processing time: 93 Days and 2.8 Hours
Stoma creation is a common procedure in colorectal cancer surgery, however, stoma-related complications remain a significant concern.
To investigate the incidence, types, and risk factors of stoma-related complications in colorectal cancer patients who underwent stoma creation.
Patients with stoma was prospectively recorded in the established stoma system. Data was collected from this stoma management system from November 2021 through May 2024. The rates of stoma-related complications were assessed, and potential risk factors were analyzed using univariate and multivariate logistic regression models.
A total of 734 patients were included in the analysis. The results showed that 12.3% of patients experienced stoma-related complications, with mucocutaneous separation, edema, and skin excoriation being the most common complications. The majority (90%) of complications were classified as grade 2 according to the Clavien-Dindo classification. Surgical factors, such as blood loss volume greater than 500 mL and open surgery, were significantly associated with stoma complications. Additionally, stoma features like location, shape, color, height, and edema were important factors in the association with complications. Body mass index over 30 kg/m² was also found to be a significant risk factor.
These findings highlight the need for a holistic approach to preventing and managing stoma complications, considering both patient-related and surgical factors.
Core Tip: Among 734 colorectal cancer patients with stomas, 12.3% experienced stoma related complications, among which mucocutaneous separation, edema, and skin excoriation were the most common ones. The majority of complications were low grade (grade 1-2) by Clavien-Dindo classification. Key risk factors included surgical factors (blood loss > 500 mL, open surgery), stoma features (stoma location, shape, color, height and edema), and body mass index > 30 kg/m², emphasizing the need for comprehensive stoma management.
- Citation: Chen N, Zhang J, Wang L, Yang Q, Wu AW. Stoma related complications: A registry study based on a prospective registration system. World J Gastrointest Oncol 2025; 17(3): 102604
- URL: https://www.wjgnet.com/1948-5204/full/v17/i3/102604.htm
- DOI: https://dx.doi.org/10.4251/wjgo.v17.i3.102604
Colorectal surgery often involves stoma creation, particularly in the event of perforation[1]. Gastrointestinal (GI) oncological surgery and surgical resection techniques have become a focus of attention in recent years, however, standardized procedure for stoma creation has been controversial[2]. Additionally, surgeons tend to prioritize other aspects, so a significant portion of stoma care management is delegated to nurses. Multidisciplinary teams effectively facilitate communication among physicians, nurses, and patients, enabling life-long, comprehensive stoma management[3].
Stoma complications are a source of concern for patients undergoing GI surgery, particularly those undergoing stoma procedures. These complications can lead to morbidity and impact patient quality of life[4]. Despite advancements in surgical techniques and postoperative care, the incidence of stoma complications remains high, ranging from 21% up to 70%[5,6]. The aim of this study is to provide a comprehensive overview of stoma types, complications, incidence, po
This study investigated the rates of stoma-related complications and potential risk factors in colorectal cancer patients who underwent stoma creation at the Gastrointestinal Cancer Center, Unit III, Peking University Cancer Hospital from November 2021 through May 2024. The clinical data of patients who underwent stoma creation were retrieved from the stoma management system. The development and application of this system were previously published in Chinese by the Information Department of Peking University Cancer Hospital. The status and description of the stoma were regularly assessed by dedicated enterostomal therapists (ET), starting from when the patient returns to the ward after surgery, and stoma information were prospectively collected and recorded in detail at each visit. The protocol was approved by the ethics committee of Beijing Cancer Hospital, and all participants were provided written informed consent.
The inclusion criteria were as follows: (1) Adults aged 18-80 years; (2) Eastern Collaborative Oncology Group score of 0-2; and (3) Pathologically confirmed colorectal malignancy. The exclusion criteria were as follows: (1) Nonmalignant diseases, such as inflammatory bowel disease; (2) Stoma creation at another hospital; and (3) Other illnesses or abnormal mental states that could affect participation in this study.
The patients in this study were routinely followed up in the stoma clinic, and stoma information, including stoma features (with photos) and other physical assessments by specialized stoma care nurses, was recorded simultaneously. Patients returned for follow-up examination 2 weeks, 1 month, 3 months, and 6 months post-ostomy surgery. Patient characteristics (including primary surgery, pathological staging, etc.) and stoma information were collected from the system.
Stoma creation has been standardized in our institution. Our specialized stoma care nurses documented a range of complications, including parastomal hernia, stenosis, prolapse, retraction, and skin excoriation, as well as daytime and nighttime leakage, peristomal abscess, and intestinal occlusion. Additionally, the strategies for managing these complications were recorded. The CD classification, also known as the modified Clavien–Dindo classification, is a system used to assess the severity of ostomy complications to therefore ascertain the level of intervention needed and the type of healthcare resources needed. This classification system provides clearer and more specific guidance for the management of ostomy complications, with detailed grading references drawn from previously published articles.
Categorical variables were analyzed via the χ2 test or Fisher’s exact test. A two-sided P value < 0.05 indicated statistical significance. All the statistical analyses were performed via SPSS software (Version 26.0; IBM Corp., New York, United States).
From November 2021 through May 2024, a total of 755 patients were assessed for eligibility in the stoma registry system. Nine patients were excluded (met the exclusion criteria). A total of 12 patients were excluded because of incomplete follow-up data.
Of the study population, 492 patients (67.0%) were less than 65 years, and 242 patients (33.0%) were over 65 years, with the median age of 59.9 years. 681 patients (92.8%) had a body mass index (BMI) less than 30 (median BMI 24.6). The average duration of surgery was 152.2 minutes, and the duration of surgery was longer than 4 hours for 56 patients (7.6%). The median intra-operative blood loss was 95.2 mL, and 23 patients (3.1%) had the blood loss over 500 mL. Seventeen patients (2.3%) had the diagnosis of hypertension, and 35 patients (8.7%) had diabetes, as shown in Table 1.
| Factors | n (%) |
| Age (year) | |
| < 65 | 492 (67.0) |
| ≥ 65 | 242 (33.0) |
| Sex | |
| Male | 473 (64.4) |
| Female | 261 (35.6) |
| BMI (kg/m2) | |
| < 30 | 681 (92.8) |
| ≥ 30 | 53 (7.2) |
| Duration of surgery (hour) | |
| < 4 | 678 (92.4) |
| ≥ 4 | 56 (7.6) |
| Blood loss (mL) | |
| < 500 | 711 (96.9) |
| ≥ 500 | 23 (3.1) |
| Length of stay (day) | |
| ≤ 7 | 262 (35.7) |
| > 7 | 472 (64.3) |
| Tumor location | |
| Rectal | 650 (88.6) |
| Colon | 84 (11.4) |
| Adenocarcinoma | |
| Yes | 716 (97.5) |
| No | 18 (2.5) |
| pT stage | |
| ≤ T3 | 607 (82.7) |
| T4 | 127 (17.3) |
| pN stage | |
| pN0 | 642 (87.5) |
| pN+ | 92 (12.5) |
| Neoadjuvant CRT | |
| Yes | 524 (71.4) |
| No | 210 (28.6) |
| Surgery type | |
| Lap | 583 (79.4) |
| Open | 151 (20.6) |
| Hypertension | |
| Yes | 17 (2.3) |
| No | 717 (97.7) |
| Diabetes | 35 (8.7) |
| Yes | 96 (13.1) |
| No | 638 (86.9) |
In terms of stoma location, 482 patients (65.7%) had ileo-stomas, and 218 patients (29.7%) had colon stomas. As for the stoma height, 693 patients (94.4%) had stoma with the height between 1 to 3 cm, and other stoma height (either less than 1 cm or greater than 3 cm) was observed in 41 patients (5.6%). As another important description, stoma with normal color was found in majority of patients; however, 10 patients had a stoma with abnormal color (dark gray, an indicator of ischemia). Edema was observed in 124 patients (16.9%). Only 9 patients (1.2%) had an irregularly shaped stoma, as shown in Table 2. In total, 90 patients (12.3%) experienced stoma related complications, and 64 cases experienced complications within 7 days after stoma creation (was defined as “early complications”), compared with those occurring over 7 days (“late complications”).
| Factors | n (%) |
| Stoma location | |
| Ileostoma | 482 (65.7) |
| Colon stoma | 218 (29.7) |
| Stoma height (cm) | |
| 1-3 | 693 (94.4) |
| Others | 41 (5.6) |
| Stoma color | |
| Normal | 724 (98.6) |
| Abnormal | 10 (1.4) |
| Stoma edema | |
| Yes | 124 (17.0) |
| No | 607 (83.0) |
| Stoma shape | |
| Regular | 725 (98.8) |
| Irregular | 9 (1.2) |
The most common stoma related complications were mucocutaneous separation, edema, skin excoriation and ischemia, which occurred in 31 (34.4%), 22 (24.4%), 15 (16.7%), and 11 (12.2%) patients, respectively. The data on early complications (within 7 days after surgery) demonstrated that mucocutaneous separation was observed in 24 patients (26.7%) in the early phase and therefore considered a significant early complication. Moreover, bleeding was observed in 4 patients (4.4%), all of whom experienced bleeding in the early period. Eleven cases (12.2%) with ischemia, were all observed within 7 days. Edema, characterized by mucosal swelling around the stoma, was the most prevalent early complication, affecting 22 patients (24.4%). Additionally, prolapse was observed in 1 patient (1.1%) during the early period. Furthermore, parastomal hernia and stoma retraction, both of which are structural abnormalities, were observed in 1 patient each during the early phase. The data on late complications (7 days or more after surgery) comparatively revealed that 2 patients (2.2%) developed a fistula in the late period postoperatively. Skin excoriation, involving irritation and damage to the skin around the stoma, was observed in 12 patients (13.3% of late complications). Late-onset mucocutaneous separation was noted in 7 patients (7.8% of late complications). Additionally, 1 case of stoma retraction and 1 case of parastomal hernia were reported in the late phase.
All complications were classified according to the Clavien-Dindo classification, as shown in Table 3. Five patients experienced grade 1 complications, while 81 patients experienced grade 2 complications. Only 4 patients experienced grade 3 complications, 3 patients had grade 3a complications, and 1 patient with prolapse, which is considered a grade 3b complication, underwent stoma reconstruction surgery. No severe complications (grade 4-5) were observed.
| Number of patients (%) | Early (≤ 7 days) | Late (> 7 days) | |
| Bleeding | 4 (4.4) | 3 | 1 |
| Ischemia | 11 (12.2) | 11 | 0 |
| Fistula | 2 (2.2) | 0 | 2 |
| Retraction | 1 (1.1) | 0 | 1 |
| Prolapse | 2 (4.4) | 1 | 1 |
| Edema | 22 (24.4) | 21 | 1 |
| Parastomal hernia | 2 (2.2) | 1 | 1 |
| Skin excoriation | 15 (16.7) | 3 | 12 |
| Mucocutaneous separation | 31 (34.4) | 24 | 7 |
| Time of complication (day) | |||
| ≤ 7 | 64 (71.1) | ||
| > 7 | 26 (28.9) | ||
| Clavien–Dindo classification | |||
| 1 | 5 (5.5) | ||
| 2 | 81 (90.0) | ||
| 3 | 4 (4.44) | ||
| 4 | 0 | ||
| 5 | 0 |
Analysis of the associations between clinicopathological factors and stoma complications revealed that there were certain factors significantly associated with the occurrence of stoma related complications. Surgical factors, such as blood loss (over 500 mL), surgery type (open surgery), were significantly corelated with stoma complications (with P = 0.05, P = 0.00, respectively). Moreover, stoma features, such as location (ileostoma), shape, color, height and edema were shown as important factors in the association with complications (with P values of statistically significance). Besides, the incidence of complications was higher in patients with a BMI over 30 (kg/m²) than in those with a BMI less than 30 (kg/m²; P = 0.01).
Certain factors, such as age, sex, and tumor location, did not shown to have a statistically significant effect on the occurrence of stoma complications, as evidenced by P values of 0.90, 0.91, and 0.73, respectively. Similarly, cT (P = 0.96), cN stage (P = 0.21) and neoadjuvant chemoradiation therapy (CRT; P = 0.95) were not significantly associated with stoma complications. Although the incidence of complications was higher in patients with a longer duration of surgery (over 4 hours) than in those with a shorter duration of surgery (less than 4 hours; 11.7% vs 7.1%); however, the difference was not statistically significant (P = 0.18), as shown in Table 4.
| Factors | With complications, n = 90 | No complication, n = 644 | P value |
| Age (year) | 0.90 | ||
| < 65 | 61 (67.8) | 431 (66.9) | |
| ≥ 65 | 29 (32.2) | 213 (33.1) | |
| Sex | 0.91 | ||
| Male | 59 (65.6) | 414 (64.3) | |
| Female | 31 (34.4) | 230 (35.7) | |
| Tumor location | 0.73 | ||
| Rectal | 81 (90.0) | 569 (88.4) | |
| Colon | 9 (10.0) | 75 (11.6) | |
| cT stage | 0.96 | ||
| cT1-3 | 61 (67.8) | 435 (67.5) | |
| cT4 | 29 (32.2) | 209 (32.5) | |
| cN stage | 0.21 | ||
| cN0 | 18 (20.0) | 96 (14.9) | |
| cN+ | 72 (80.0) | 548 (85.1) | |
| pT stage | 0.64 | ||
| pT1-3 | 76 (84.4) | 531 (82.5) | |
| pT4 | 14 (15.6) | 113 (17.5) | |
| pN stage | 0.07 | ||
| pN0 | 62 (68.9) | 381 (59.2) | |
| pN+ | 28 (31.1) | 263 (40.8) | |
| Neoadjuvant CRT | 0.95 | ||
| Yes | 26 (28.9) | 184 (28.6) | |
| No | 64 (71.1) | 460 (71.4) | |
| Duration of surgery (hour) | 0.18 | ||
| < 4 | 80 (88.9) | 598 (92.9) | |
| ≥ 4 | 10 (11.1) | 46 (7.1) | |
| Blood loss (mL) | 0.05 | ||
| < 500 | 84 (93.3) | 627 (97.4) | |
| ≥ 500 | 6 (6.7) | 17 (2.6) | |
| Length of stay (days) | 0.06 | ||
| ≤ 7 | 24 (26.7) | 238 (37.0) | |
| > 7 | 66 (73.3) | 406 (63.0) | |
| Hypertension | 0.42 | ||
| Yes | 1 (1.1) | 16 (2.5) | |
| No | 89 (98.9) | 628 (97.5) | |
| Diabetes | 0.21 | ||
| Yes | 8 (8.9) | 88 (13.7) | |
| No | 82 (91.1) | 556 (86.3) | |
| Stoma location | 0.00a | ||
| Ileostoma | 53 (58.9) | 199 (30.9) | |
| Colon stoma | 37 (41.1) | 445 (69.1) | |
| Stoma color | 0.00a | ||
| Normal | 81 (90.0) | 643 (99.8) | |
| Abnormal | 9 (10.0) | 1 (0.2) | |
| Stoma shape | 0.05 | ||
| Regular | 87 (96.7) | 638 (99.1) | |
| Irregular | 3 (3.3) | 6 (0.9) | |
| Surgery type | 0.01a | ||
| Laparoscopic | 61 (67.8) | 522 (81.1) | |
| Open | 29 (32.2) | 122 (18.9) | |
| Stoma edema | 0.00a | ||
| Yes | 27 (30.0) | 97 (15.1) | |
| No | 63 (70.0) | 547 (84.9) | |
| BMI | - | 0.01a | |
| < 30 | 78 (86.7) | 603 (93.6) | |
| ≥ 30 | 12 (13.3) | 41 (6.4) | |
| Stoma height (cm) | 0.05 | ||
| 1-3 | 76 (84.4) | 607 (94.3) | |
| Others | 14 (15.6) | 37 (5.7) |
A multivariate binary logistic regression model was used to analyze the independent risk factors associated with stoma complications. Notably, the type of surgery was a statistically significant independent risk factor, with an odds ratio (OR) of 1.039 to 3.169 (95%CI: 1.815, P = 0.036). Additionally, stoma color and stoma edema were highly significant factors, with ORs ranging from 0.001 to 0.085 (95%CI: 0.010, P = 0.000) and 0.206 to 0.594 (95%CI: 0.350, P = 0.000), respectively. While other factors, such as stoma location, pN stage, duration of surgery, stoma height, stoma shape, and BMI, were included in the model, they were not statistically significant in predicting stoma complications, as shown in Table 5.
| Factors | OR (95%CI) | P value |
| Age | 0.582-1.605 (0.967) | 0.895 |
| Sex | 0.618-1.661 (1.013) | 0.959 |
| Stoma location | 0.600-3.150 (1.375) | 0.451 |
| pN | 0.954-2.678 (1.598) | 0.075 |
| Duration of surgery | 0.303-1.726 (0.724) | 0.467 |
| Type of surgery | 1.039-3.169 (1.815) | 0.036 |
| Stoma height | 0.229-1.409 (0.568) | 0.222 |
| Stoma color | 0.001-0.085 (0.010) | 0.000 |
| Stoma edema | 0.206-0.594 (0.350) | 0.000 |
| Stoma shape | 0.072-1.426 (0.321) | 0.135 |
| BMI | 0.930-1.065 (0.995) | 0.895 |
As concerned, the incidence of stoma related complications varied among literature[7]. Results of our registry demonstrated that 12.3% pf patients suffered from stoma related complications, which was lower than those from previous studies[5,7]. Since 2010, our center has established a multi-modal management mechanism for stoma care, combining professional stoma therapists and standardized stoma treatment and nursing practices. By collaborating with surgeons, rehabilitation specialists, and other disciplines, the whole process management for stoma patients has been established including the areas of preoperative stoma site marking, intraoperative stoma creation techniques, and postoperative stoma care, together with management after discharge[8,9]. As reported by previous studies, preoperative stoma marking, which was routinely implemented in every individual patient, resulted in reduction of stoma complications[10]. Furthermore, a consensus on enterostomy surgery based on abdominal wall stress has been recognized by experts[11], bringing in a platform with relative uniformity of this surgical approach for future multi-center clinical observational studies. Moreover, during the post-operative period (hospital stay and after 30 days after discharge), case managers conduct regular follow-ups with stoma patients, closely monitoring the stoma output (volume and nature) and providing corresponding dietary guidance. Specifically, for patients with small intestine stomas, when high output warnings arise, patients would receive prompt medical suggestions, significantly reducing the incidence of high-output stoma complications before happening.
In our study, we investigated different types and classification of stoma-related complications. Of the 734 patients included, mucocutaneous separation, edema, skin excoriation were the top 3 most common complications, with the rates of 34.4%, 24.4% and 16.7%, respectively. Skin excoriation (also known as “skin problem”) was regarded as one of the most common complications[12], probably due to the fact that the stoma diameter does not match the baseplate of the ostomy bag. With specialized guiding from ET, rates of skin excoriation and the leakage, as well as the associated prickling sensations have been effectively controlled, as previously reported[13]. Notably, 64 patients experienced complications within 7 days after stoma creation, indicating a high incidence of early complications. Early complications, as defined in our study, as complications occurring within 7 days after surgery, were found to be more common than late complications. The most frequent early complications were ischemia and mucocutaneous separation, which may be related to surgical technique, stoma location, and patient factors such as BMI and blood loss volume. Late complications, on the other hand, were more likely to be related to stoma care management and patient adherence to postoperative instructions. In terms of specific complications, ischemia was observed in 11 (12.2%) patients, all patients experienced ischemia in the early postoperative period. This highlights the importance of careful monitoring of the stoma blood supply in the immediate postoperative period to prevent ischemia and its potential sequelae. Fistula, another serious complication, was observed in 2 (2.2%) patients in the late postoperative period. These findings suggest that long-term surveillance and management of stoma patients are crucial for detecting and managing potential complications such as fistulas.
Based on detailed records of complication types, this study further explored the severity of these complications. Analysis of the classification by Clavien-Dindo revealed that majority of these complications (90%) were classified as grade 2, with only 4 patients experienced grade 3 complications. Among the patients who suffered from grade 3 complications, 3 patients had grade 3a complications, and 1 patient required surgery (stoma reconstruction surgery) due to stoma prolapse, classified as grade 3b complication. No severe complications (grades 4-5) were observed in our study. These findings suggest that though stoma complications are common, most cases are manageable with appropriate interventions, and severe complications are relatively rare. Thus, our study were one of the pioneer investigations for evaluating the severity of stoma related complications using Clavien-Dindo grading system[14]. Integrated with Clavien-Dindo grading, a detailed criteria regarding the classifications of these complications might introduce a more universally applicable classification method with guidance of strategies to manage each case. By categorizing complications on the basis of the level of intervention required and the associated healthcare resources needed.
In addition to severity, this study further explored the clinicopathological factors associated with the complications, demonstrating several interesting findings. While factors such as age, sex, tumor location, cN (lymph node), did not appear to have a statistically significant effect on the occurrence of stoma complications, there were factors that showed a trend toward significance. The incidence of complications was higher in patients with duration of surgery longer (more than 4 hours) than in those whose duration of surgery was shorter (less than 4 hours; 11.7% vs 7.1%), but the difference between the two groups was not statistically significant (P = 0.18).
Notably, these factors were found to be significantly associated with stoma complications. A blood loss volume greater than 500 mL was significantly associated with stoma complications (P = 0.05), as evidenced by a higher incidence of complications in these patients, which was consistent with risk factors for other surgical intervention[15]. Stoma location
Our multivariate binary logistic regression model revealed that the type of surgery was a statistically significant independent risk factor for stoma complications. Specifically, patients who underwent open surgery were more likely to experience complications than those who underwent laparoscopic surgery. This finding is consistent with previous studies, which highlighted the advantages of laparoscopic surgery in reducing postoperative complications, including those related to stomas[16,17]. Minimally invasive surgery utilizes small incisions, thereby reducing postoperative incisional pain. Additionally, the instruments used in minimally invasive surgery handle tissues more gently, minimizing extensive tissue manipulation. The minimally invasive nature of laparoscopic surgery may contribute to a faster recovery, reduced pain, and a decreased risk of infection, all of which can contribute to a lower incidence of stoma complications.
Interestingly, several of these factors have been previously identified as potential risk factors for stoma complications in other studies. For example, stoma location has been shown to impact the incidence of complications, with ileostoma generally having a higher rate than colon stoma. Similarly, an irregularly shaped stoma, edema, and a higher BMI have also been associated with an increased risk of complications. Intriguingly, we found a significant association between blood loss volume and stoma complications, as evidenced by a higher incidence of complications in patients with blood loss volume greater than 500 mL than in those with a blood loss volume less than 500 mL. This finding suggests that controlling blood loss during surgery may be an important strategy for reducing the risk of stoma complications. Similarly, the duration of surgery also showed a trend toward significance, with a greater proportion of complications in patients whose surgery lasted more than 4 hours than in those whose surgery lasted less than 4 hours. This highlights the importance of efficient and skilled surgical techniques in minimizing the risk of postoperative complications.
There are still a few limitations of this study. In the first place, despite not reaching statistical significance in our model, the trends observed for certain factors suggest that they might still play a role in the development of stoma complications, while several studies mentioned the diabetes might be a risk factors for stoma complications[18], which was not supported by our data. Our analysis also revealed that certain clinicopathological factors, such as age, sex, and tumor location, did not significantly affect the occurrence of stoma complications. This finding might be different with results from other studies; a nationwide analysis showed that compared with men, women were more likely to suffer from stoma related complications[18]. However, it is possible that the differences in study populations, surgical techniques, and postoperative care may account for these discrepancies. On the other side, the lack of statistical significance may be due to the relatively small sample size in our study or the presence of other confounding factors. Therefore, it might be of importance to consider these factors in a holistic approach to prevent and manage stomal complications. The second limitation is that this study is constrained by the observation period. The longest follow-up duration for the included patients is only three years. Therefore, the incidence of some long-term stoma complications, such as hernias, is relatively low due to the relatively short observation time. Therefore, as data accumulating, this data platform will incorporate more real-world cases, laying solid foundation for future research.
In conclusion, our study revealed that the type of surgery was a statistically significant independent risk factor for stoma complications in patients who underwent stoma procedures. While other factors, such as stoma location, pN stage, duration of surgery, stoma height, stoma shape, and BMI, did not reach statistical significance in our model, they may still play a role in the development of these complications. Therefore, a holistic approach to preventing and managing stoma complications, considering both patient-related and surgical factors, is recommended. In the future, large-sample studies and more comprehensive data collection may help to further elucidate the risk factors for stoma complications and improve patient outcomes.
We wish to acknowledge the support and encouragement provided by our colleagues, especially Li-Jun Wang and Xin-Jing Wang for their contributions in the maintenance of the stoma system.
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