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.

Development and pilot testing of a patient-reported outcome measure to assess symptoms of parastomal hernia.

AIM: The aim was to develop and pilot a patient-reported outcome measure (PROM) to assess symptoms of parastomal hernia (PSH). METHODS: Standard questionnaire development was undertaken (phases 1-3). An initial list of questionnaire domains was identified from validated colorectal cancer PROMs and from semi-structured interviews with patients with a PSH and health professionals (phase 1). Domains were operationalized into items in a provisional questionnaire, and 'think-aloud' patient interviews explored face validity and acceptability (phase 2). The updated questionnaire was piloted in patients with a stoma who had undergone colorectal surgery and had a computed tomography scan available for review. Patient-reported symptoms were examined in relation to PSH (phase 3). Three sources determined PSH presence: (i) data about PSH presence recorded in hospital notes, (ii) independent expert review of the computed tomography scan and (iii) patient report of being informed of a PSH by a health professional. RESULTS: For phase 1, 169 and 127 domains were identified from 70 PROMs and 29 interviews respectively. In phase 2, 14 domains specific to PSH were identified and operationalized into questionnaire items. Think-aloud interviews led to three minor modifications. In phase 3, 44 completed questionnaires were obtained. Missing data were few: 5/660 items. PSH symptom scores associated with PSH presence varied between different data sources. The scale with the most consistent differences between PSH presence and absence and all data sources was the stoma appearance scale. CONCLUSION: A PROM to examine the symptoms of PSH has been developed from the literature and views of key informants. Although preliminary testing shows it to be understandable and acceptable it is uncertain if it is sensitive to PSH-specific symptoms and further psychometric testing is needed.

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.

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.

The effect of telemedicine on stoma-related complications in adults with enterostomy: A systematic review and meta-analysis.

To assess the effect of telemedicine on stoma-related complications in adults with enterostomy, we conducted a meta-analysis to evaluate the effects of the telemedicine group compared to the usual group. Literature searches were performed in PubMed, Embase, Web of Science, The Cochrane Library, China Biology Medicine (CBM), China National Knowledge Infrastructure (CNKI), WanFang and VIP databases from their inception up to October 2023. Two authors independently screened and extracted data from the included and excluded literature according to predetermined criteria. Data collected were subjected to meta-analysis using Review Manager 5.3 software. The final analysis included a total of 22 articles, encompassing 2237 patients (telemedicine group: 1125 patients, usual group: 1112 patients). The meta-analysis results demonstrated that, compared to the usual group, the telemedicine group significantly reduced the overall occurrence of stoma-related complications, with an odds ratio (OR) of 0.22 (95% CI = 0.15-0.32, p < 0.00001). Furthermore, it resulted in a decrease in stoma complications (OR = 0.27, 95% CI = 0.15-0.47, p < 0.00001) and peristomal complications (OR = 0.25, 95% CI = 0.19-0.34, p < 0.00001). Therefore, the existing evidence suggests that the application of telemedicine can reduce the incidence of stoma and peristomal complications, making it a valuable clinical recommendation.

Timing of restoration of bowel continuity after decompressing stoma, in left-sided obstructive colon cancer: a nationwide retrospective cohort.

BACKGROUND: With the increasing use of decompressing stoma as a bridge to surgery for left-sided obstructive colon cancer (LSOCC), the timing of restoration of bowel continuity (ROBC) is a subject of debate. There is a lack of data on immediate ROBC during elective resection as an alternative for a 3-stage procedure. This study analysed if immediate ROBC during tumour resection is safe and of any benefit for patients who underwent decompressing stoma for LSOCC. METHODS: In a Dutch nationwide collaborative research project, 3153 patients who underwent resection for LSOCC in 75 hospitals (2009-2016) were identified. Extensive data on disease and procedural characteristics, and outcomes was collected by local collaborators. For this analysis, 332 patients who underwent decompressing stoma followed by curative resection were selected. Immediate ROBC during tumour resection was compared to two no immediate ROBC groups, (1) tumour resection with primary anastomosis (PA) with leaving the decompressing stoma in situ, and (2) tumour resection without PA. RESULTS: Immediate ROBC was performed in 113 patients (34.0%) and no immediate ROBC in 219 patients [168 with PA (50.6%) and 51 patients without PA (15.4%)]. No differences at baseline between the groups were found for age, ASA score, cT, and cM. Major surgical complications (8.8% immediate ROBC vs. 4.8% PA with decompressing stoma and 7.8% no PA; P =0.37) and mortality (2.7% vs. 2.4% and 0%, respectively; P =0.52) were similar. Immediate ROBC resulted in a shorter time with a stoma (mean 41 vs. 240 and 314 days, respectively; P <0.001), and fewer permanent stomas (7% vs. 21% and 80%, respectively; P <0.001) as compared to PA with a decompressing stoma or no PA. CONCLUSION: After a decompressing stoma for LSOCC, immediate ROBC during elective resection appears safe, reduces the total time with a stoma and the risk of a permanent stoma.

Prophylactic mesh does not prevent parastomal hernia in long-term: Meta-analysis and trial sequential analysis.

BACKGROUND: Previous randomized clinical trials, systematic reviews, and meta-analyses evaluating parastomal hernia prevention with mesh placement during end colostomy formation have reported contradictory results. This review aimed to assess the efficacy of this strategy in long-term follow-up according to the latest available data. METHODS: Medline, EMBASE, Cochrane Library, Web of Science, and Google Scholar were searched. Randomized clinical trials were included if they compared mesh with no mesh during initial end colostomy creation in adult patients to prevent parastomal hernia with a follow-up longer than 2 years. A meta-analysis was performed to evaluate parastomal hernia incidence (primary outcome), parastomal hernia repair rate, and mortality. Subgroup analysis included surgical approach and mesh position, and trial sequential analysis was performed. RESULTS: Eight randomized clinical trials involving 537 patients met the inclusion criteria. Based on long-term follow-up, the incidence of parastomal hernia was not reduced when a prophylactic mesh was placed (relative risk = 0.68 [95% confidence interval:0.46-1.02]; I2 = 81%, P =.06). The parastomal hernia repair rate was low; however, no difference was found between the groups (relative risk = 0.90 [95% confidence interval:0.51-1.56]; I2 = 0%; P = .70), and no difference was detected between the groups when mortality was assessed (relative risk = 1.03 [95% confidence interval: 0.77-1.39]; I2 = 21%; P = .83). Subgroup analyses did not show differences according to the surgical approach or mesh position used. Regarding trial sequential analysis, an optimal information size was not achieved. CONCLUSION: Prophylactic mesh placement during end colostomy formation does not prevent parastomal hernia in the long term. The parastomal hernia repair rate and mortality rate did not vary between the included groups. Heterogeneity among the included randomized clinical trials might restrict the reliability of the results.

Open retromuscular keyhole compared with Sugarbaker mesh for parastomal hernia repair: Early results of a randomized clinical trial.

BACKGROUND: Open parastomal hernia repair can be performed using retromuscular synthetic mesh in a keyhole or Sugarbaker configuration. Relative morbidity and durability are unknown. Here, we present perioperative outcomes of a randomized controlled trial comparing these techniques, including 30-day patient-reported outcomes, reoperations, and wound complications in ≤90 days. METHODS: This single-center randomized clinical trial compared open parastomal hernia repair with retromuscular medium-weight polypropylene mesh in the keyhole and Sugarbaker configuration for permanent stomas between April 2019 and April 2022. Adult patients with parastomal hernias requiring open repair with sufficient bowel length for either technique were included. Patient-reported outcomes were collected at 30 days; 90-day outcomes included initial hospital length of stay, readmission, wound morbidity, reoperation, and mesh- or stoma-related complications. RESULTS: A total of 150 patients were randomized (75 keyhole and 75 Sugarbaker). There were no differences in length of stay, readmission, reoperation, recurrence, or wound complications. Twenty-four patients (16%) required procedural intervention for wound morbidity. Ten patients (6.7%) required abdominal reoperation in ≤90 days, 7 (4.7%) for wound morbidity, including 3 partial mesh excisions (1 keyhole compared with 2 Sugarbaker; P = 1). Four mesh-related stoma complications requiring reoperations occurred, including stoma necrosis (n = 1), bowel obstruction (n = 1), parastomal recurrence (n = 1), and mucocutaneous separation (n = 1), all in the Sugarbaker arm (P = .12). Patient-reported outcomes were similar between groups at 30 days. CONCLUSION: Open parastomal hernia repair with retromuscular mesh in the keyhole and Sugarbaker configurations had similar perioperative outcomes. Patients will be followed to determine long-term relative durability, which is critical to understanding each approach's risk-benefit ratio.

Hernia Active Living Trial (HALT): an exercise intervention in people with a parastomal hernia or bulge.

BACKGROUND: Parastomal hernias are a common consequence of stoma surgery and can occur in up to 50% of patients. They are mangaged either conservatively, through support hosiery, or surgically. A patient feasibility study called the Hernia Active Living Trial (HALT) was designed to examine if a clinical pilates-based exercise programme offers an alternative approach to managing a parastomal hernia or bulge. METHOD: Adults with an ileostomy or colostomy who perceived they had a bulge around their stoma were included in the study. The intervention included up to 12 online sessions of an exercise booklet and videos with an exercise specialist. Interviews were conducted to explore participants' experiences of the intervention. The interview data were analysed systematically and thematically. Participants were also asked to complete patient diaries every week. RESULTS: Twelve of the 13 participants who completed the intervention agreed to be interviewed. Following analysis, three main themes emerged including managing a hernia/bulge, benefits and barriers. Participants talked about the benefits of this programme including: reduction of the size of their hernia, increased abdominal control, body confidence and posture, as well as increased physical activity levels. The barriers described were generally overcome allowing participants to engage in what was perceived to be a positive and potentially life-changing experience. CONCLUSIONS: A clinical pilates-based exercise programme for people with a parastomal hernia can bring both direct and indirect improvements to a patient's hernia management, sense of wellbeing and day-to-day life. Individuals with a hernia should be informed about the need for, and value of, exercise to strengthen core muscles, as part of their non-surgical options for self-management.

Risk factors associated to incisional hernia in stoma site after stoma closure: A systematic review and meta-analysis.

BACKGROUND: This study aims to identify which risk factors are associated with the appearance of an incisional hernia in a stoma site after its closure. This in the sake of identifying which patients would benefit from a preventative intervention and thus start implementing a cost-effective protocol for prophylactic mesh placement in high-risk patients. METHODS: A systematic review of PubMed, Cochrane library, and ScienceDirect was performed according to PRISMA guidelines. Studies reporting incidence, risk factors, and follow-up time for appearance of incisional hernia after stoma site closure were included. A fixed-effects and random effects models were used to calculate odds ratios' estimates and standardized mean values with their respective grouped 95% confidence interval. This to evaluate the association between possible risk factors and the appearance of incisional hernia after stoma site closure. RESULTS: Seventeen studies totaling 2899 patients were included. Incidence proportion between included studies was of 16.76% (CI95% 12.82; 21.62). Out of the evaluated factors higher BMI (p = 0.0001), presence of parastomal hernia (p = 0.0023), colostomy (p = 0,001), and end stoma (p = 0.0405) were associated with the appearance of incisional hernia in stoma site after stoma closure, while malignant disease (p = 0.0084) and rectum anterior resection (p = 0.0011) were found to be protective factors. CONCLUSIONS: Prophylactic mesh placement should be considered as an effective preventative intervention in high-risk patients (obese patients, patients with parastomal hernia, colostomy, and end stoma patients) with the goal of reducing incisional hernia rates in stoma site after closure while remaining cost-effective.

Laparoscopic parastomal hernia repair: keyhole, Sugarbaker, sandwich, or hybrid technique with 3D mesh? An updated systematic review and meta-analysis.

PURPOSE: Parastomal hernia is the most common complication after stoma formation with an incidence that approaches 50% at 2 years postoperatively. In the last decade, different approaches of minimally invasive procedures have been proposed for the treatment of parastomal hernia. Nevertheless, the superiority of one technique over the others remains still unclear. Our objective was to update and systematically analyze current state of research concerning the postoperative outcomes of the four most prevalent minimally invasive techniques. METHODS: A systematic literature search of three databases (Medline, Scopus, Google Scholar) was undertaken for articles published from January 2015 to November 2022. Fifteen studies from a previous meta-analysis on the topic were included. RESULTS: Thirty-three studies incorporating 1289 total patients were deemed eligible for inclusion in the final analysis. The keyhole technique was associated with the highest incidence of postoperative complications and recurrences (31.3% and 24.1%, respectively), followed by the Sugarbaker technique (27.6% and 9%, respectively). Operative time was among the lowest in patients operated with the 3D mesh technique, while patients undergoing the keyhole technique experienced the shortest cumulative length of hospital stay (6 days). CONCLUSION: Each technique demonstrates a unique profile of effectiveness offset by the propensity towards developing postoperative complications. While no conclusive evidence on the optimal technique exist to date, newer minimally invasive techniques show promising results, albeit based on limited data. The future of parastomal hernia repair seems to rely on a highly individualized approach, tailored to the distinctive characteristics of both the hernia and the patient.

Using a convex ostomy appliance to manage peristomal skin complications: introducing Aura Plus Soft Convex.

This article explores convex stoma appliances, introduces Aura Plus Soft Convex (CliniMed) and presents three case studies of its use. Convexity applies pressure to flatten uneven peristomal skin and form an effective adhesive seal, as well as increase protrusion of a poorly spouted stoma. This reduces the risk of leaks and peristomal skin damage, as well as minimising accessory use. Excess pressure can damage the skin, so convexity should be used with caution at the appropriate depth and firmness for the ostomate's body profile and stomal complications. Aura Plus Soft Convex has a soft and flexible baseplate for easy application and adherence, as well as a unique shape, comfort curves and a large adhesive area to reduce creases and leaks. The hydrocolloid contains Manuka honey to promote skin health, and integral belt loops offer additional security. The case studies show how this appliance can restore peristomal skin integrity and relieve stoma-related anxiety; provide gentle support for a flush stoma and a rounded abdomen; and prevent leaks and improve quality of life after years of stoma-related complications.

Understanding patients' perspectives when unprepared for the emergence of a parastomal bulge-a qualitative study.

AIM: The aim was to investigate patients' experiences of being prepared for the development of a parastomal bulge in relation to a stoma. METHODS: The paper draws on a qualitative interview study conducted with 20 Danish patients participating in five focus groups. Analysis was performed using a phenomenological-hermeneutic approach. RESULTS: We identified three themes. The first theme is 'The unforeseen bulge gives rise to increasing concern and a search for an explanation'. Patients searched for explanations in their own life and suspected that their behaviour or previous illness induced the bulge. The second theme is 'Missing or confusing information leads to counterproductive behaviour'. Patients lacked information on the prevention and treatment of parastomal bulging which led to disappointment with healthcare professionals. The third theme is 'Weighing the pros and cons of life with the bulge against the gamble of surgical repair'. Some patients came to terms with their situation, but for others a deadlocked situation arose when surgical repair was not an option. CONCLUSION: Healthcare communication directly impacts on patients' experiences and outcomes. When unprepared for the emergence of a parastomal bulge, patients' emotional and psychological well-being are affected and likewise patients' possibility of using their own health beliefs as a preventive strategy. To preserve patient autonomy, satisfaction and well-being, surgeons and stoma nurses should provide patients with tailored information bearing in mind the current lack of clear evidence on the prevention and treatment of parastomal bulging.