Predictors for temporary stomas non-closure among non-metastatic rectal cancer patients undergoing curative resection: a retrospective analysis.

BACKGROUND: The primary treatment for non-metastatic rectal cancer is curative resection. However, sphincter-preserving surgery may lead to complications. This study aims to develop a predictive model for stoma non-closure in rectal cancer patients who underwent curative-intent low anterior resection. METHODS: Consecutive patients diagnosed with non-metastatic rectal cancer between January 2005 and December 2017, who underwent low anterior resection, were retrospectively included in the Chang Gung Memorial Foundation Institutional Review Board. A comprehensive evaluation and analysis of potential risk factors linked to stoma non-closure were performed. RESULTS: Out of 956 patients with temporary stomas, 10.3% (n = 103) experienced non-closure primarily due to cancer recurrence and anastomosis-related issues. Through multivariate analysis, several preoperative risk factors significantly associated with stoma non-closure were identified, including advanced age, anastomotic leakage, positive nodal status, high preoperative CEA levels, lower rectal cancer presence, margin involvement, and an eGFR below 30 mL/min/1.73m2. A risk assessment model achieved an AUC of 0.724, with a cutoff of 2.5, 84.5% sensitivity, and 51.4% specificity. Importantly, the non-closure rate could rise to 16.6% when more than two risk factors were present, starkly contrasting the 3.7% non-closure rate observed in cases with a risk score of 2 or below (p < 0.001). CONCLUSION: Prognostic risk factors associated with the non-closure of a temporary stoma include advanced age, symptomatic anastomotic leakage, nodal status, high CEA levels, margin involvement, and an eGFR below 30 mL/min/1.73m2. Hence, it is crucial for surgeons to evaluate these factors and provide patients with a comprehensive prognosis before undergoing surgical intervention.

Complications associated with loop ileostomy: analysis of risk factors.

BACKGROUND: Loop ileostomy is a common surgical procedure but is associated with complications such as outlet obstruction (OO), parastomal hernia (PH), and high-output stoma (HOS). This study aimed to identify risk factors for these complications, as well as their causal relationships. METHODS: The study included 188 consecutive patients who underwent loop ileostomy between April 2016 and September 2021. Clinical factors and postoperative stoma-related complications (OO, HOS, and PH) were analyzed retrospectively. Stoma-related factors were evaluated using specific measurements from computed tomography (CT) scans. The incidence, clinical course, and risk factors for the stoma-related complications were investigated. RESULTS: OO was diagnosed in 28 cases (15.7%), PH in 60 (32%), and HOS in 57 (31.8%). A small longitudinal stoma diameter at the rectus abdominis level on CT and a right-sided stoma were significantly associated with OO. Creation of an ileostomy for anastomotic leakage was independently associated with HOS. Higher body weight and a large longitudinal stoma diameter at the rectus abdominis level on CT were significantly associated with PH. There was a significant relationship between the occurrence of OO and HOS. However, the association between OO and PH was marginal. CONCLUSION: This study identified key risk factors for OO, HOS, and PH as complications of loop ileostomy and their causal relationships. Our findings provide insights that may guide the prevention and management of complications related to loop ileostomy.

Clostridium difficile infection after stoma reversal surgery: a systematic review and meta-analysis of the literature.

BACKGROUND: Clostridium difficile infection (CDI) has been described in the early post-operative phase after stoma reversal. This systematic review aimed to describe the incidence of CDI after stoma reversal and to identify pre-operative variables correlated with an increased risk of infection. METHODS: A systematic review of the literature was conducted according to the PRISMA guidelines in March 2024. Manuscripts were included if reported at least one patient with CDI-associated diarrhoea following stoma reversal (colostomy/ileostomy). The primary outcome of interest was the incidence of CDI; the secondary outcome was the comparison of clinical variables (age, sex, time to stoma reversal, neo-adjuvant and adjuvant therapies after index colorectal procedure) in CDI-positive versus CDI-negative patients. A meta-analysis was performed when at least three studies reported on those variables. RESULTS: Out of 43 eligible manuscripts, 1 randomized controlled trial and 10 retrospective studies were selected, including 17,857 patients (2.1% CDI). Overall, the mean age was 64.3 ± 11.6 years in the CDI group and 61.5 ± 12.6 years in the CDI-negative group (p = 0.51), with no significant difference in sex (p = 0.34). Univariable analyses documented that the mean time to stoma reversal was 53.9 ± 19.1 weeks in CDI patients and 39.8 ± 15.0 weeks in CDI-negative patients (p = 0.40) and a correlation between neo-adjuvant and adjuvant treatments with CDI (p < 0.001). A meta-analysis was performed for time to stoma reversal, age, sex, and neo-adjuvant therapies disclosing no significant differences for CDI (stoma delay, MD 11.59; 95%CI  24.32-1.13; age, MD 0.97; 95%CI 2.08-4.03; sex, OR1.11; 95%CI 0.88-1.41; neo-adjuvant, OR0.81; 95%CI 0.49-1.35). Meta-analysis including patients who underwent adjuvant therapy evidenced a higher risk of CDI (OR 2.88; 95%CI 1.01-8.17, p = 0.11). CONCLUSION: CDI occurs in approximately 2.1% of patients after stoma reversal. Although a trend of increased delay in stoma reversal and a correlation with chemotherapy were documented in CDI patients, the use of adjuvant therapy was the only possible risk factor documented on meta-analysis. PROSPERO REGISTRATION NUMBER: CRD42023484704.

Management of the Difficult Stoma.

Fecal ostomy creation is a commonly performed procedure with many indications. Better outcomes occur when preoperative patient education and stoma site marking are provided. Despite a seemingly simple operation, ostomy creation is often difficult and complications are common. Certain risk factors, particularly obesity, are strongly associated with stoma-related complications. The ability to optimize the ostomy and stoma in the operating room and to troubleshoot frequently encountered post-operative stoma-related issues are critical skills for surgeons and ostomy nurses alike.

The Effect of Stoma Site Marking on Stomal Complications: A Long-term Retrospective Study.

OBJECTIVE: To identify the effect of stoma site marking on stoma-related complications. METHODS: The study sample included 639 individuals with stomas who were followed up in a stomatherapy unit in Turkey between January 1, 2017, and June 20, 2021. Researchers collected patient data from nursing records. Data were evaluated using number, percentage, χ2, and logistic regression tests. RESULTS: Of the individuals with stomas, 60.6% (n = 387) were men, and 72.6% (n = 464) had a cancer diagnosis. Their mean age was 60.16 (SD, 14.81) years. The stoma site was marked preoperatively in of 67.1% of patients (n = 429), and 17.1% (n = 109) developed stoma-related complications. The complication rate was higher in individuals with unmarked stoma sites (25.7%; P = .000), emergency surgeries (25.0%; P = .006), colostomies (23.9%; P = .042), and permanent stomas (28.3%; P = .002). The three most common complications were peristomal skin problems (56.9%), mucocutaneous separation (13.8%), and edema (9.2%). CONCLUSIONS: The incidence of stoma-related complications in the postoperative period was higher in individuals with unmarked stoma sites. The authors recommend that stoma and wound care nurses mark the stoma site in individuals for whom stoma creation is planned.

Risk factors for stoma prolapse after laparoscopic loop colostomy.

BACKGROUND: Stoma prolapse (SP) is a common stoma-related complication, particularly in loop colostomies. This study aimed to investigate potential risk factors for SP development after laparoscopic loop colostomy. METHODS: In total, data from 140 patients who underwent laparoscopic loop colostomy were analyzed between September 2016 and March 2022. Risk factors for SP were investigated retrospectively. RESULTS: The median follow-up duration after colostomy was 12.5 months, and SP occurred in 33 (23.6%) patients. Multivariate analysis showed that being overweight (body mass index ≥ 25; odds ratio [OR], 8.69; 95% confidential interval [CI], 1.61-46.72; p = 0.012) and having a thin rectus abdominis penetration of the stoma (< 8.9 mm; OR, 8.22; 95% CI, 2.50-27.05; p < 0.001) were independent risk factors for SP. Other patient characteristics and surgical factors associated with stoma construction were unrelated to SP development. CONCLUSIONS: Being overweight and the route penetrating the thinner rectus abdominis during stoma construction was associated with a significantly higher incidence of SP after laparoscopic loop colostomy. Selecting a construction site that penetrates the thicker rectus abdominis muscle may be crucial for preventing SP.

Robotic modified Sugarbaker technique for parastomal hernia repair: a standardized approach.

Parastomal hernia (PSH) is a prevalent long-term morbidity associated with stoma construction, and the optimal operative management remains uncertain. This study addresses the need for a standardized approach to symptomatic PSH repair, focusing on the robotic-assisted modified Sugarbaker technique with composite permanent mesh. The study, conducted in a high-volume colon and rectal surgery referral practice, outlines a systematic approach to patient selection, surgical procedures, and postoperative care. Preoperative evaluations include detailed medical and surgical histories, impact assessments of PSH, and oncological history reviews. The surgical technique involves the Da Vinci Xi™ robotic platform for adhesiolysis, hernia content reduction, stoma revision if needed, narrowing of the enlarged stoma trephine, lateralization of the stoma limb of bowel, and securing the mesh to the abdominal wall. Outcomes are reported for 102 patients undergoing robotic parastomal hernia repair from January 2021 to July 2023. Conversion to open surgery occurred in only one case (0.9%). Postoperative complications affected 39.2% of patients, with ileus being the most frequent (24.5%). Recurrence was observed in 5.8% of cases during an average follow-up of 10 months. In conclusion, parastomal hernia, a common complication post-stoma creation, demands surgical intervention. The robotic-assisted modified Sugarbaker repair technique, as outlined in this paper, offers promising results in terms of feasibility and outcomes.

Assessment of the quality of online patient information resources for patients considering parastomal hernia treatment.

AIM: The aim was to examine the quality of online patient information resources for patients considering parastomal hernia treatment. METHODS: A Google search was conducted using lay search terms for patient facing sources on parastomal hernia. The quality of the content was assessed using the validated DISCERN instrument. Readability of written content was established using the Flesch-Kincaid score. Sources were also assessed against the essential content and process standards from the National Institute for Health and Care Excellence (NICE) framework for shared decision making support tools. Content analysis was also undertaken to explore what the sources covered and to identify any commonalities across the content. RESULTS: Fourteen sources were identified and assessed using the identified tools. The mean Flesch-Kincaid reading ease score was 43.61, suggesting that the information was difficult to read. The overall quality of the identified sources was low based on the pooled analysis of the DISCERN and Flesch-Kincaid scores, and when assessed against the criteria in the NICE standards framework for shared decision making tools. Content analysis identified eight categories encompassing 59 codes, which highlighted considerable variation between sources. CONCLUSIONS: The current information available to patients considering parastomal hernia treatment is of low quality and often does not contain enough information on treatment options for patients to be able to make an informed decision about the best treatment for them. There is a need for high-quality information, ideally co-produced with patients, to provide patients with the necessary information to allow them to make informed decisions about their treatment options when faced with a symptomatic parastomal hernia.

Postoperative outcomes and identification of risk factors for complications after emergency intestinal stoma surgery - a multicentre retrospective study.

AIM: Approximately 4000 patients in the UK have an emergency intestinal stoma formed each year. Stoma-related complications (SRCs) are heterogeneous but have previously been subcategorized into early or late SRCs, with early SRCs generally occurring within 30 days postoperatively. Early SRCs include skin excoriation, stoma necrosis and high output, while late SRCs include parastomal hernia, retraction and prolapse. There is a paucity of research on specific risk factors within the emergency cohort for development of SRCs. This paper aims to describe the incidence of SRCs after emergency intestinal surgery and to identify potential risk factors for SRCs within this cohort. METHOD: Consecutive patients undergoing emergency formation of an intestinal stoma (colostomy, ileostomy or jejunostomy) were identified prospectively from across three acute hospital sites over a 3-year period from the ELLSA (Emergency Laparotomy and Laparoscopic Scottish Audit) database. All patients were followed up for a minimum of 1 year. A multivariate logistic regression model was used to identify risk factors for early and late SRCs. RESULTS: A total of 455 patients were included (median follow-up 19 months, median age 64 years, male:female 0.52, 56.7% ileostomies). Early SRCs were experienced by 54.1% of patients, while 51% experienced late SRCs. A total of 219 patients (48.1%) had their stoma sited preoperatively. Risk factors for early SRCs included end ileostomy formation [OR 3.51 (2.24-5.49), p < 0.001], while preoperative stoma siting was found to be protective [OR 0.53 (0.35-0.83), p = 0.005]. Patient obesity [OR 3.11 (1.92-5.03), p < 0.001] and reoperation for complications following elective surgery [OR 4.18 (2.01-8.69), p < 0.001] were risk factors for late SRCs. CONCLUSION: Stoma-related complications after emergency surgery are common. Preoperative stoma siting is the only truly modifiable risk factor to reduce SRCs, and further research should be aimed at methods of improving the frequency and accuracy of this in the emergency setting.

Management of adult intestinal stomas: The 2023 French guidelines.

AIM: Digestive stoma are frequently performed. The last French guidelines have been published twenty years ago. Our aim was to update French clinical practice guidelines for the perioperative management of digestive stoma and stoma-related complications. METHODS: A systematic literature review of French and English articles published between January 2000 and May 2022 was performed. Only digestive stoma for fecal evacuation in adults were considered. Stoma in children, urinary stoma, digestive stoma for enteral nutrition, and rare stoma (Koch, perineal) were not included. RESULTS: Guidelines include the surgical landmarks to create digestive stoma (ideal location, mucocutaneous anastomosis, utility of support rods, use of prophylactic mesh), the perioperative clinical practice guidelines (patient education, preoperative ostomy site marking, postoperative equipment, prescriptions, and follow-up), the management of early stoma-related complications (difficulties for nursing, high output, stoma necrosis, retraction, abscess and peristomal skin complications), and the management of late stoma-related complications (stoma prolapse, parastomal hernia, stoma stenosis, late stoma retraction). A level of evidence was assigned to each statement. CONCLUSION: These guidelines will be very useful in clinical practice, and allow to delete some outdated dogma.

Development of a leakage impact assessment for patients with a stoma, who may be impacted by leakage.

For people living with a stoma leakage is unpredictable. Despite advances in stoma products, leakage can lead to soiling and this, along with worrying about leakage, can significantly affect patients' everyday lives and impact their quality of life. It is also associated with excessive product use and increased healthcare resources. Leakage therefore remains a major unmet need for many people living with a stoma. To address this, Coloplast Ltd in collaboration with the authors and a broader group of stoma care nurses have worked together to develop a first version of the Leakage Impact Assessment. This assessment is intended to identify patients who struggle with leakage and leakage worry, and who might benefit from the reassurance that a new digital leakage notification system, Heylo™, can provide. This article reviews the evidence for leakage and its impact on people living with a stoma and outlines the development process for the assessment.

Early diverting stoma closure is feasible and safe: results from a before-and-after study on the implementation of an early closure protocol at a tertiary referral center.

BACKGROUND: Evidence on early closure (EC) of defunctioning stoma (DS) after colorectal surgery shows a favorable effect when patients are carefully selected. Therefore, a clinical pathway adapted to the implementation of an EC strategy was developed in our center. The aim of this study was to carry out a comparative analysis of time until DS closure and DS-related morbidity before and after the implementation of an EC protocol (ECP). METHODS: This study is a before-and-after comparative analysis. Patients were divided into two cohorts according to the observational period: patients from the period before the ECP implementation (January 2015-December 2019) [Period 1] and those from the period after that (January 2020-December 2022) [Period 2]. All consecutive patients subjected to elective DS closure within both periods were eligible. Early closure was defined as the reversal within 30 days from DS creation. Patients excluded from EC or those not closed within 30 days since primary surgery were analyzed as late closure (LC). Baseline characteristics and DS-related morbidity were recorded. RESULTS: A total of 145 patients were analyzed. Median time with DS was shorter in patients after ECP implementation [42 (21-193) days versus 233 (137-382) days, p < 0.001]. This reduction in time to closure did not impact the DS closure morbidity and resulted in less DS morbidity (68.8% versus 49.2%, p = 0.017) and fewer stoma nurse visits (p = 0.029). CONCLUSIONS: The ECP was able to significantly reduce intervals to restoration of bowel continuity in patients with DS, which in turn resulted in a direct impact on the reduction of DS morbidity without negatively affecting DS closure morbidity.

Reversal of stoma with biosynthetic mesh fascial reinforcement: a systematic review and meta-analysis.

AIM: Temporary stoma formation remains a common part of modern-day colorectal surgical operations. At the time of reversal, a second procedure is required when the bowel is anastomosed and the musculature is closed. The rate of incisional hernia at these sites is 30%-35% with conventional suture closure. Mesh placement at this site is therefore an attractive option to reduce hernia risk, particularly as new mesh types, such as biosynthetic meshes, are available. The aim of this work was to conduct a systematic review and meta-analysis assessing the use of mesh for prophylaxis of incisional hernia at stoma closure and to explore the outcome measures used by each of the included studies to establish whether they are genuinely patient-centred. METHOD: This is a systematic review and meta-analysis assessing the published literature regarding the use of mesh at stoma site closure operations. Comprehensive literature searches of major electronic databases were performed by an information specialist. Screening of search results was undertaken using standard systematic review principles. Data from selected studies were input into an Excel file. Meta-analysis of the results of included studies was conducted using RevMan software (v.5.4). Randomized controlled trial (RCT) and non-RCT data were analysed separately. RESULTS: Eleven studies with a total of 2008 patients were selected for inclusion, with various mesh types used. Of the included studies, one was a RCT, seven were nonrandomized comparative studies and three were case series. The meta-analysis of nonrandomized studies shows that the rate of incisional hernia was lower in the mesh reinforcement group compared with the suture closure group (OR 0.21, 95% CI 0.12-0.37) while rates of infection and haematoma/seroma were similar between groups (OR 0.7, 95% CI 0.41-1.21 and OR 1.05, 95% CI 0.63-1.80, respectively). The results of the RCT were in line with those of the nonrandomized studies. CONCLUSION: Current evidence indicates that mesh is safe and reduces incisional hernia. However, this is not commonly adopted into current clinical practice and the literature has minimal patient-reported outcome measures. Future work should explore the reasons for such slow adoption as well as the preferences of patients in terms of outcome measures that matter most to them.

The PROPHER study: patient-reported outcomes after parastomal hernia treatment-a prospective international cohort study.

AIM: A significant proportion of stoma patients develop a parastomal hernia (PSH), with reported rates varying widely from 5% to 50% due to heterogeneity in the definition and mode of diagnosis. PSHs are symptomatic in 75% of these patients, causing a significant impact on quality of life due to issues with appliance fitting, leakage, skin excoriation and pain. They can also lead to emergency presentations with strangulation and obstruction. Evidence is lacking on how to select patients for surgical intervention or conservative treatment. In those who do undergo surgery, the best operation for a particular patient or PSH is not always clear and many options exist. The aim of this study is to assess the impact of an individual patient's PSH treatment on their subsequent self-reported outcomes including treatment success and quality of life. METHODS: This is a prospective international cohort study of PSH treatment, including both operative and non-operative interventions. A global network of clinicians and specialist nurses will recruit 1000-1500 patients and centralize detailed information, their individual background and their PSH treatment, as well as short-term outcomes up to 30 days. Patients will then provide their own outcomes data including quality of life and whether their treatment was successful, via a secure online system, at 3, 6 and 12 months. PROPHER will be run in two phases: an internal pilot phase of at least 10 hospitals from up to five countries, and a main phase of up to 200 hospitals from across the European Society of Coloproctology network. DISCUSSION: This study will provide a wealth of contemporaneous information which will improve our ability to counsel patients and facilitate improved selection of appropriate and personalized interventions for those with a PSH.

Development and preliminary evaluation of a novel procedure for creation of an ileal conduit stoma aimed at preventing parastomal hernia.

OBJECTIVES: Our previous study suggested that the operative procedure is critical for the development of parastomal hernia. We developed a novel procedure for the creation of an ileal conduit stoma to prevent parastomal hernia. Herein we evaluate the efficacy and safety of the procedure. METHODS: A total of 113 Japanese patients underwent radical cystectomy and ileal conduit diversion for bladder cancer from January 2017 through December 2021 at our institution. After excluding those with incomplete data, 103 patients consisting of 46 (44.7%) with the conventional procedure and 57 (55.3%) with the novel procedure were consecutively enrolled. The main points of the novel procedure are as follows: (1) the passage of the ileal conduit is ≤2.4 cm in diameter in principle; (2) the posterior rectus sheath and peritoneum are vertically incised 2 cm laterally from the middle of the stoma site to make an oblique passage for the ileal conduit; and (3) the anterior rectus sheath and posterior rectus sheath with peritoneum are fixed to the ileal conduit separately. RESULTS: Radiography-based parastomal hernia was observed in 11 patients (10.7%) with a median follow-up of 22.0 months. The incidences of parastomal hernia were 3.5% and 19.6% in the novel and the conventional procedure groups, respectively (p = 0.011). The former had a significantly lower cumulative incidence of parastomal hernia (p = 0.008, log-rank test). No specific complications associated with the procedure were observed. CONCLUSIONS: The results of the preliminary cohort study suggest that the novel procedure is safe and effective for the prevention of parastomal hernia.

The clinical applications of D-type parastomal hernia repair surgery.

OBJECTIVE: This study investigated the use of a modified laparoscopic repair of paraostomy hernia technique, called "D-Type parastomal hernia repair surgery" which combines abdominal wall and extraperitoneal stoma reconstruction, in patients with parastomal hernia (PSH) following colorectal stoma surgery. The aim was to determine whether D-type parastomal hernia repair surgery is a promising surgical approach compared to the traditional laparoscopic repair technique (Sugarbaker method) for patients with PSH. METHODS: PSH patients were selected and retrospectively divided into two groups: the study group underwent D-type parastomal hernia repair, while the control group underwent laparoscopic Sugarbaker repair. Clinical data from both groups were analyzed. RESULT: Compared to control group (n = 68), the study group undergoing D-type stoma lateral hernia repair had significant increase in total operative time (98.82 ± 12.37 min vs 124.61 ± 34.99 min, p < 0.001). The study group also showed better postoperative stoma bowel function scores in sensory ability, frequency of bowel movements, and clothing cleanliness without a stoma bag (p = 0.037, 0.001, 0.002). The treatment cost was significantly higher in the control group (3899.97 ± 260.00$ vs 3215.91 ± 230.03$, p < 0.001). The postoperative recurrence rate in the control group was 26.4%, while in the study group, it was 4.3%, with a significant statistical difference (p = 0.024). In terms of long-term postoperative complications, the study group had an overall lower incidence compared to the control group (p = 0.035). Other parameters showed no significant differences between the two groups. CONCLUSION: The study suggests that D-type parastomal hernia repair surgery is a safe and feasible procedure. Compared to traditional surgery, it can reduce the recurrence of lateral hernia, improve postoperative stoma bowel function, and save medical resources.

Pediatric Tracheotomy Stomal Maturation and Tracheocutaneous Fistulas.

OBJECTIVE: The purpose of this study is to determine whether tracheostomy stomal maturation affects the risk of tracheocutaneous fistula (TCF) in children. METHODS: A retrospective chart review was conducted for all children who both underwent a tracheostomy and were decannulated between 2012 and 2021 at a tertiary children's hospital. Charts were analyzed for demographics, surgical technique, and development of a TCF. TCF was defined as a persistent fistula following 3 months after decannulation. RESULTS: 179 children met inclusion criteria. The median (interquartile range) age at tracheostomy was 1.5 (82.4) months, average (standard deviation [SD]) duration of tracheotomy was 20.0 (20.6) months, and length of follow-up after decannulation (range; SD) was 39.3 (4.4-110.0; 26.7) months. 107 patients (60.0%) underwent stomal maturation and 98 patients developed a TCF (54.7%). Younger age at tracheostomy placement was significantly associated with increased risk of TCF, mean (SD) age 28.4 (51.4) version 80.1 (77.5) months (p < 0.001). Increased duration of tracheostomy was significantly associated with increased risk of TCF, 27.5 (18.4) version 11.0 (18.2) months (p < 0.001). Stomal maturation was not significantly associated with the risk of TCF, including on multivariable analysis adjusting for age at tracheostomy and duration of tracheostomy (p = 0.089). CONCLUSION: Tracheostomy stomal maturation did not affect the risk of TCF in children, even after adjusting for age and duration of tracheostomy. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2941-2944, 2024.