Early postoperative complications of elective versus emergency stoma creation: a tertiary academic center experience.

BACKGROUND: Stoma creation is standard in general surgery, yet complication rates remain high. PURPOSE: This study investigated the incidence and risk factors for early postoperative stoma complications in elective vs emergency surgery. METHODS: All patients who underwent stoma creation between June 2015 and November 2020 were retrospectively reviewed and analyzed. Patients were divided into 2 groups based on the surgery type: elective vs emergency. RESULTS: A total of 375 patients were included in this study. Two hundred fifty-three patients (67.5%) underwent elective stoma creation, while 122 (32.5%) underwent stoma creation during an emergency surgery. In the emergency group, white blood cell, blood urea nitrogen, and creatinine levels were statistically significantly higher (P = .001, .001, and .002, respectively). Albumin levels were statistically significantly lower in the emergency group (P = .001). The mean Emergency Surgery Score was 5.17 ± 2.73 in the emergency group compared to 4.4 ± 2.44 in the elective group (P = .006). Colorectal cancer was the most common cause of stoma creation in both groups. In terms of stoma creation, colostomy was statistically significantly more common in the emergency group (59%, P = .001), compared to ileostomy in the elective group (58.9%, P = .001). Complications were observed in 135 of all patients (36%). Necrosis was statistically significantly more common in emergency cases (9.9%, P < .001). CONCLUSION: Surgeons should strive to optimize the patient's condition prior to the operation and, if possible, perform stoma marking or involve a stoma nurse in the operating room to select the most suitable site. In high-risk patients, where complications are more likely, the use of a stoma should be minimized and definitive management should always be pursued if feasible.

The validity and reliability of the Urostomy Education Scale: a methodological study.

BACKGROUND: There are no scales used by stoma and wound care nurses to evaluate the stoma care skills of individuals with a urostomy. PURPOSE: This study was conducted to investigate the Turkish validity and reliability of the Urostomy Education Scale (UES). METHODS: The study sample consisted of 66 patients who had undergone radical cystectomy, were in the 0- to 7-day postoperative period, were older than 18 years of age, had no physical or mental disabilities, had no urostomy complications, and agreed to participate in the study. This study used translation and back-translation to determine the linguistic validity of the UES in Türkiye. Expert opinion was consulted for content validity. Then, 2 competent and 2 experienced nurses evaluated the face validity of the scale with 5 individuals with urostomies. Reliability of the scale was assessed using internal consistency, interrater reliability, and intraclass correlation coefficients. RESULTS: The content validity index was 0.81 and α = 0.66 to 0.95 for the Cronbach's alpha of the competent nurse assessment and α = 0.68 to 0.96 in the expert nurse assessment. The intraclass correlation coefficient (ICC) results indicated sufficient and statistically significant agreement (ICC range: 0.6-1) between the evaluations made by the 2 evaluators for each skill. CONCLUSION: The Turkish version of the 7-item UES is a valid and reliable tool that can be used to determine the self-care levels of individuals with a urostomy.

Postoperative rectovaginal fistula: stoma may not be necessary-a French retrospective cohort.

BACKGROUND: Postoperative rectovaginal fistula leads to a loss of patients' quality of life and presents significant challenges to the surgeon. The literature focusing specifically on postoperative rectovaginal fistulas is limited. The objective of the present study is to identify factors that can enhance the success of the management of this postoperative rectovaginal fistula. METHODS: This retrospective multicentric study included all patients undergoing surgery for rectovaginal fistulas, excluding those for whom the etiology of rectovaginal fistula was not postoperative. The major outcome measure was the success of the procedure. RESULTS: A total of 82 patients with postsurgical fistulas were identified, of whom 70 were successfully treated, giving a success rate of 85.4%. On average, these patients required 3.04 ± 2.72 interventions. The creation of a diversion stoma did not increase the success rate of management [odds ratio (OR) = 0.488; 95% confidence interval (CI) 0.107-2.220]. Among the 217 procedures performed, 69 were successful, accounting for a 31.8% success rate. The number of interventions and the creation of a diversion stoma did not correlate with the success of management. However, direct coloanal anastomosis was significantly associated with success (OR = 35.06; 95% CI 1.271-997.603; p = 0.036) as compared with endorectal advancement flap (ERAF). Other procedures such as Martius flap did not show a significantly higher success rate. CONCLUSION: The creation of a diversion stoma is not necessary in closing a fistula. ERAF should be considered as a first-line treatment prior to proposing more invasive approach such as direct coloanal anastomosis.

Analysis of the correlation between defunctioning stoma and postoperative low anterior resection syndrome in rectal cancer: a prospective cohort study.

BACKGROUND: To evaluate the effect of stoma-related factors (stoma or no stoma, stoma type, and stoma reversal time) on the occurrence of low anterior resection syndrome (LARS), a highly prevalent condition that can develop after anal sphincter-sparing surgery for rectal cancer and impair quality of life, which includes fecal incontinence, fecal urgency and frequent defecation. METHODS: Patients who underwent radical rectal cancer surgery from July 2018 to July 2022 in a tertiary hospital were included. Baseline data, tumor condition, operation condition and postoperative recovery were obtained by clinical observation. Follow-up data were collected by telephone follow-up. The chi-square and Fisher exact tests were used to analyse differences, coefficient of contingency was used to determine correlations, and independent risk factors for the occurrence of LARS (Patients with a score of 21 or more points were defined as having LARS using the LARS score) were further determined by binary logistic regression. RESULTS: A total of 480 patients met the inclusion criteria, of which 267 used a defunctioning stoma and 213 did not use a defunctioning stoma. There was a positive correlation between defunctioning stoma (P < 0.001, P < 0.001, P < 0.05) and the occurrence of LARS at 3, 6, and 12 months postoperatively, and there was no significant correlation between the stoma type or stoma reversal time and the occurrence of LARS at 3, 6 and 12 months postoperatively (P > 0.05). In binary logistic regression analysis, high BMI (Exp(B) = 1.072, P = 0.039), tumor closer to dentate line (Exp(B) = 0.910, P = 0.016), and ultra-low anterior resection (Exp(B) = 2.264, P = 0.011) increased the possibility of LARS at 3 months postoperatively; high BMI, proximity of the tumor to the dentate line, and ultra-low anterior resection were not independent risk factors for LARS at 6 months postoperatively (P > 0.05). However, proximity of the tumor to the dentate line (Exp(B) = 0.880, P = 0.035) increased the likelihood of LARS at 12 months postoperatively, while high BMI and ultra-low anterior resection remained non-significant as independent risk factors for LARS at 12 months postoperatively (P > 0.05). CONCLUSIONS: Defunctioning stoma was not an independent risk factor for the occurrence of LARS, whereas high BMI, tumor closer to dentate line, and ultra-low anterior resection were independent risk factors for the occurrence of LARS. TRIAL REGISTRATION: Not applicable.

Investigating colostomy-related morbidity in children following stoma formation and closure in a tertiary hospital, Abha, Saudi Arabia: a retrospective cohort study 2024.

BACKGROUND: Overall, stoma-related morbidity affects a reported 20-38% of pediatric patients. However, determining the true incidence of major stoma-related morbidity is challenging due to limited cohort sizes in existing studies. Thus, the aim of this study was to investigate colostomy related morbidity among children both after stoma formation and stoma closure. METHODOLOGY: This is a retrospective cohort hospital-based study, conducted in an Abha maternity and children hospital, between August 1, 2018, and August 1, 2023, among 126 pediatric patients (aged 0-12 years) who underwent colostomy formation and subsequent closure during the study period. Data were collected from medical records. Data was analyzed using Statistical Package for Social Sciences (SPSS) v.26. RESULTS: This study included a total of 126 children who underwent colostomy. (N = 37, 29.4%) of cases included in this study were emergency cases, while (N = 89, 70.6%) were elective. A variety of antibiotics were used for surgical prophylaxis, metronidazole (77%) and cefuroxime (62.7%) were the most prevalent. Oral feeding was started after 5-6 days in more than one third of cases (39.7%). Wound infection (N = 15, 11.9%) was the most reported post-operative complication, followed with bowel obstruction (N = 6, 4.8%). Emergency cases had a longer duration of hospital stay than elective cases; this difference was statistically significant (P = .04). CONCLUSIONS: Majority of patients reported no stoma related complications, while among those who reported complications, wound infection was the most reported complication, followed by bowel obstruction.

Robotic extraperitoneal stoma closure with left hemicolectomy for descending colon cancer following abdominoperineal resection: A case report.

Extraperitoneal colostomy is often selected to reduce the risk of parastomal hernia. However, its closure surgery is rare and seldom reported. Here, we report our unique experience with robotic left hemicolectomy and extraperitoneal colostomy closure. An 83-year-old female was diagnosed with descending colon cancer with stenosis. She had previously undergone abdominoperineal resection with extraperitoneal colostomy. After improving the intestinal obstruction with a self-expanding stent, we performed robotic left hemicolectomy and extraperitoneal colostomy closure. Thanks to the multijoint function of the robot, which enables the forceps to be angled up to 90° in all directions, we could dissect the stoma from the abdominal wall up to just beneath the rectus abdominis in an intra-abdominal procedure without enlarging the skin incision. This case suggests that robotic surgery with the articulating function is beneficial for procedures near the abdominal wall ceiling and effective for extraperitoneal colostomy closure.

Robotic Pauli repair of parastomal hernia.

BACKGROUND: Robotic retro-muscular mesh repair of parastomal hernia (PH) is possible with transversus abdominis release. The aim of this study is to report mid-term results with this method. METHODS: Patients who underwent surgery for PH were enrolled in a prospective study. Patients with concomitant midline hernia also underwent Rives repair. Polypropylene meshes with an absorbable buffer mesh were used in the retro-muscular pocket-except PTFE was chosen for inflammatory bowel disease patients. Follow-up was by telephone and physical examination and CT if suspicion of complication. RESULTS: Of the 56 included ostomy patients, 44 had colostomies, 10 had ileostomies, and two had urostomies. Thirty-nine percent had a concomitant hernia, and 25% had recurrent PH. The mean operating time without accessory repair was 156 min (SD 37), and with accessory repairs 220 min (SD 62). One bowel lesion and one vascular injury to the stoma occurred, prompting intraoperative stoma revision without postoperative morbidity. Postoperative complications ensued in 12 patients (23%). One patient had stoma necrosis after 3 weeks and the stoma was relocated. One patient had a mesh infection, 3 patients temporary ileus, one patient hypovolemic renal failure, and two patients experienced a flare-up of their Crohn's Disease. One parastomal abscess was drained percutaneously. The median postoperative stay was 3 days (1-21; mean 3.7 days), and the readmission rate was 8.9%. The recurrence rate at mean and median 24 months follow-up is 5.4%, two in ileostomy patients and one colostomy patient with unaltered bulging where CT shows a relatively large prolapse and recorded as a failure. CONCLUSION: Robotic Pauli repair has shown promising results. However, repair fails of PH at small bowel ostomies with short mesentery. ePauli/TAR is now the preliminary choice for eligible patients at our site. Comparative studies with the intraperitoneal mesh standard are needed.

Development and Validation of the Satisfaction Concerning Stoma Care Questionnaire (SSCQ).

PURPOSE: The purpose of this research was to develop the Satisfaction Concerning Stoma Care Questionnaire (SSCQ) and evaluate its structural and convergent validity and internal reliability. DESIGN: Instrument development and evaluation of validity and reliability. SUBJECTS AND SETTING: A preliminary 22-item SSCQ was administered in a larger web-based survey to members of 2 ostomy-related patient associations with members throughout the Netherlands. The data of patients who underwent surgery within 2 years were selected for analysis. METHODS: The development of the SSCQ was informed by a preexisting survey that focused on the experiences of stoma patients with general health care. Structural validity and homogeneity of the SSCQ were assessed using explanatory factor analysis and Cronbach's α coefficients. Convergent validity was also evaluated. RESULTS: The final SSCQ comprised 20 items covering 3 domains: "preoperative care and information," "postoperative care and guidance," and "contact with and ostomy nurse." The SSCQ demonstrated structural and convergent validity and internal reliability. The Cronbach's α value of the SSCQ was 0.95, whereas the independent domains retrieved a high α coefficient ranging from 0.90 to 0.93. The SSCQ and independent domains were able to distinguish between high and low patients' ratings for satisfaction concerning the received stoma care. CONCLUSIONS: The SSCQ demonstrated structural and convergent reliability, along with internal consistency. It may be used to measure the satisfaction of patients with ostomies concerning stoma care. Future prospective studies using the SSCQ are needed to generate additional insights into providing optimal care for ostomy patients.

Utilization and outcomes of Hartmann's procedure in emergency left colon surgery: evaluating postoperative complications and stoma reversal rates.

OBJECTIVE: The aim of the study was to investigate the utilization and outcomes of Hartmann's procedure in the emergency left colon surgery with respect to other stoma interventions. PATIENTS AND METHODS: A total of 70 consecutive patients (mean±SD age: 71.1±15.5 years, 51.4% were males) who underwent emergency surgery for the left colon were included in this retrospective cohort study. Data on patient demographics, primary diagnosis, emergency surgery indication, operative risk, stoma type (Hartmann's procedure, primary anastomosis with diverting loop ileostomy, double-barreled ostomy), surgeon sub-specialty, postoperative complications, and stoma reversal time and rates were recorded. RESULTS: Hartmann's procedure (72.9%) was the most commonly utilized stoma type, followed by primary anastomosis with diverting loop ileostomy (14.3%) and double-barreled ostomy (10.0%), while primary anastomosis was performed only in 2.8% of patients. The stoma reversal rate was 25.0%, and the median time to stoma reversal was 10 months (range, 3 to 48 months). Hartmann's procedure was less commonly performed by colorectal surgeons than by general surgeons (35.3% vs. 68.4%, p=0.013) and was associated with a lower chance of stoma reversal compared to other stoma types, including primary anastomosis with diverting loop ileostomy and double-barreled ostomy (15.7% vs. 52.9%, p=0.006). CONCLUSIONS: In conclusion, our findings revealed that Hartmann's procedure, although performed less commonly by colorectal surgeons than by general surgeons, was still the most prevalent procedure applied for the surgical management of left colon emergencies, particularly in the setting of tumor-induced obstruction or perforation, despite the potential risk of severe postoperative complications and lower stoma reversal rates with this procedure.

Development of a core descriptor set for parastomal hernia repair.

AIM: Parastomal hernia repair is a poorly evidenced area, with uncertainty around the optimum management. There is considerable heterogeneity within the patient cohort, and currently there is no standardization of patient descriptors in the reporting of parastomal hernia repair. The aim of this study was to develop a core descriptor set of key patient characteristics for patients undergoing surgical repair of a parastomal hernia for reporting in all parastomal hernia research. METHOD: A longlist of descriptors was generated from a review of the existing literature. The longlist was discussed with patients with lived experience of parastomal hernia repair. Colorectal, general and hernia surgeons took part in a three-round international modified Delphi process using a nine-point Likert scale to rank the importance of descriptors. Items meeting predetermined thresholds were included in the final set and discussed and ratified at the consensus meeting. RESULTS: Seventy seven respondents completed round one, with 23 (29.8%) completing round three. Eighty six descriptors were rated across the three rounds, with 52 descriptors shortlisted. The consensus meeting ratified a final core descriptor set with 19 descriptors across eight domains: anatomy, contamination, disease, previous treatment, risk factors, symptoms, pathway and other hernia. CONCLUSION: The core descriptor set reflects characteristics that are important to surgeons when reporting on parastomal hernia repair. The use of this agreed core descriptor set may aid the reporting of future studies.

Purse-string versus linear closure of the skin wound following stoma reversal: A meta-analysis with RCT and systematic review.

BACKGROUND: Linear closure (LC) following stoma reversal is associated with a high risk of surgical site infection (SSI). Purse-string closure and LC were both positive for the closure of the skin wound following stoma reversal, and it was not yet possible to distinguish which one was more beneficial to the patient's prognosis. METHODS: We conducted a search in Embase, PubMed, Web of Science, and Cochrane Library and conducted a randomized controlled experiment from the inception of each database to July 2024. Among them, the SSI within 30 days, operation time, hospitalization time, incisional hernia, and wound healing time were all outcome indicators. RESULTS: Eleven studies were included in this meta-analysis (506 patients in the purse-string closure group and 489 patients in the LC group). The pooled data showed that the SSI rate was significantly lower in the purse-string closure group than in the LC group (odds ratio, 0.15; 95% confidence interval, 0.09-0.24; P < .00001; I2 = 0%). The differences in operative time, hospitalization time, incision hernia, and wound healing time were not statistically significant. CONCLUSION: Overall, purse-string closure had a significantly lower SSI rate following stoma reversal than LC.

Evaluating EHS parastomal hernia classification for surgical planning: a retrospective analysis of 160 consecutive cases in a single center.

INTRODUCTION: Parastomal hernia (PH) is a prevalent complication following ostomy formation, presenting significant challenges in surgical management. This study aims to validate the European Hernia Society classification for PH through the application of the Hybrid Parastomal Endoscopic Repair (HyPER) method. The study focuses on establishing the practical utility of the European Hernia Society classification in a clinical setting, particularly in guiding surgical approaches and improving patient outcomes. MATERIALS AND METHODS: This retrospective observational study aimed to assess the utility of the European Hernia Society classification in planning surgical strategies for parastomal hernias. The validation of the classification of PH was based on the experience involving 160 patients in single center. Patients were classified according to the European Hernia Society criteria, and data were collected on patient demographics, clinical presentations, and surgical outcomes. Main goal was to assess the consistency and applicability of the European Hernia Society classification in predicting surgical challenges and outcomes. RESULTS: The study found a predominance of complex Type III and IV hernias. The European Hernia Society classification was effective in categorizing PH, aiding in surgical planning and highlighting the increased complication rates associated with more complex hernia types. This study represents the largest single-center cohort treated for PH by a single team, providing a controlled evaluation of the HyPER technique's effectiveness. CONCLUSIONS: The validation of the European Hernia Society classification in this study is a significant advancement in the standardization of PH management. The findings demonstrate the classification's utility in enhancing surgical planning and patient-centered care. The study also opens avenues for further research into standardized approaches and techniques in PH treatment.

Lap-re-Do Keyhole versus Lap-re-Do Sugarbaker techniques in large parastomal hernia repair: a retrospective cohort study.

PURPOSE: To review the safety and efficacy of Lap-re-Do technique in the treatment of large parastomal hernia. METHODS: We retrospectively analyzed the recurrence and complications of 81 patients with large parastomal hernia who underwent Lap-re-Do technique in Huashan Hospital of Fudan University from May 2010 to December 2019. And the patients should be able to complete follow-up. With such criteria, we included 40 Lap-re-Do Keyhole patients and 41 Lap-re-Do Sugarbaker patients. Observation time was defined as time to recurrence, death, or last nonevent visit. RESULTS: In large parastomal hernias, Lap-re-Do had a recurrence rate of 25.9% and complication rate of 16.0%, and reoperation rate of 9.9% during the average follow-up time of 41.1 ± 17.8 months. Recurrence rates were 40% (16/40) after Lap-re-Do Keyhole repair and 12.2% (5/41) after Lap-re-Do Sugarbaker repair. Complication rates were 12.5% after Lap-re-Do keyhole and 19.5% after Lap-re-Do Sugarbaker repair Re-operation rates referred to Lap-re-Do keyhole repair were 15% and Lap-re-Do Sugarbaker repair 4.9% during follow-up.The majority of reoperations were indicated by recurrence. CONCLUSIONS: Large parastomal hernias are still difficult to be treated. Lap-re-Do Sugarbaker is recommended as an appropriate procedure to close the hernia ring, removing the lengthy colostomy, and effectively reduce recurrence and complication rates.

Pregnancy and stomas: a 9-year retrospective series at a major metropolitan hospital in Brisbane Queensland.

BACKGROUND: Over 42 000 Australians live with a stoma, and this number increases annually. Pregnancy in stoma patients is a rare but complex condition and there is limited published literature regarding surgical and obstetric complications in pregnant stoma patients. The aim of this paper was to review stoma outcomes, perinatal morbidity and mortality, and early postpartum period in pregnant stoma patients. METHODS: Data was retrospectively obtained on women of childbearing age, with a stoma, who had been pregnant and birthed in the last nine years at the Royal Brisbane and Women's Hospital between January 2014 to December 2022. Data recorded included patient demographics, type of stoma, indication for stoma, need for additional abdominal surgeries, method of conception, pregnancy complications, length of stay, neonatal outcomes and post pregnancy stomal complications. RESULTS: In total, there were 16 births from 13 mothers with stomas. Of 10 births to IBD patients, 40% experienced a serious stomal complication. Caesarean section (CS) rate was 90% for IBD and 83% for non-IBD. In-vitro fertilisation rates were 40% in IBD patients and 0% in non-IBD patients. The average gestational age at delivery was 36 weeks in IBD and 35 weeks in non-IBD patients. Neonates delivered to IBD mothers had a birth weight under 2500g in 40% of cases and in non IBD mothers at 33.3% (p = 0.62). Of the sixteen births there was five complications (31.25%) associated with the stoma either during pregnancy or during the sixty-day postpartum period. CONCLUSION: Pregnancy in stoma patients is a rare occurrence and appears to be associated with high rates of CS, preterm delivery, low birth weight and stomal complication.

Early outcomes of robotic modified retromuscular Sugarbaker technique for end colostomy parastomal hernia repair.

AIM: The modified retromuscular Sugarbaker or Pauli technique is a technique for parastomal hernia repair, which requires the dissection of the retromuscular space and a transversus abdominis release for stoma lateralization and placement of a retromuscular mesh. Given the limited evidence regarding the robotic approach to this technique, this study aims to evaluate the outcomes of this newly introduced procedure, focusing on the rate of 30-day complications and recurrence rates. METHODS: Retrospective case series report. Patients included underwent an elective robotic modified retromuscular Sugarbaker technique for the repair of a parastomal hernia associated with an end colostomy. All surgeries were performed at a tertiary referral center from September 2020 to December 2023. RESULTS: A total of 21 patients underwent a robotic modified retromuscular Sugarbaker in our study. The parastomal hernias operated on were classified according to the European Hernia Society as 9.5% (2/21) type I, 52.4% (11/21) type II, 23.8% (5/21) type III, 14.3% (3/21) type IV. Early complications observed included 14.3% (3/21) seroma, 9.5% (2/21) surgical site infection, 19% (4/21) postoperative ileus, and one case of large bowel obstruction due to colitis (4.8%), which was managed conservatively. No Clavien-Dindo grade III complications were reported. The overall recurrence rate was 9.5% (2/21) with a median follow-up of 12.5 months (IQR: 3.9-21.3). Both recurrences occurred during the early phases of the learning curve and were possibly attributed to insufficient lateralization of the stoma. CONCLUSION: Robotic modified retromuscular Sugarbaker for parastomal hernia repair is a challenging procedure with promising early outcomes.

Repair of Parastomal Hernias.

Parastomal hernias are an inevitable consequence of ostomy formation and their repairs remain a challenge to many surgeons. With multiple systems of classification and a multitude of techniques for hernia repair ranging from suture to mesh repair, the literature remains sparse with regards to the optimal method of repair. The authors describe the most commonly adopted techniques, discuss preventative measures, and review the current literature in the context of perioperative outcomes and hernia recurrence.

Does one-stitch method of temporary ileostomy affect the stoma-related complications after laparoscopic low anterior resection in rectal cancer patients?

PURPOSE: This current study attempted to investigate whether one-stitch method (OM) of temporary ileostomy influenced the stoma-related complications after laparoscopic low anterior resection (LLAR). METHODS: We searched for eligible studies in four databases including PubMed, Embase, Cochrane Library, and CNKI from inception to July 20, 2023. Both surgical outcomes and stoma-related complications were compared between the OM group and the traditional method (TM) group. The Newcastle-Ottawa Scale (NOS) was adopted for quality assessment. RevMan 5.4 was conducted for data analyzing. RESULTS: Totally 590 patients from six studies were enrolled in this study (272 patients in the OM group and 318 patients in the TM group). No significant difference was found in baseline information (P > 0.05). Patients in the OM group had shorter operative time in both the primary LLAR surgery (MD = - 17.73, 95%CI = - 25.65 to - 9.80, P < 0.01) and the stoma reversal surgery (MD = - 18.70, 95%CI = - 22.48 to -14.92, P < 0.01) than patients in the TM group. There was no significant difference in intraoperative blood loss of the primary LLAR surgery (MD = - 2.92, 95%CI = - 7.15 to 1.32, P = 0.18). Moreover, patients in the OM group had fewer stoma-related complications than patients in the TM group (OR = 0.55, 95%CI = 0.38 to 0.79, P < 0.01). CONCLUSION: The OM group had shorter operation time in both the primary LLAR surgery and the stoma reversal surgery than the TM group. Moreover, the OM group had less stoma-related complications.

Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

BACKGROUND: The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5-8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall-specific quality of life score. METHODS: Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients' original allocation, even if the patient was aware of their treatment. RESULTS: Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (-2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04). CONCLUSIONS: ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall-specific quality of life 5-8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on. TRIAL REGISTRATION: ISRCTN25584182 (http://www.clinicaltrials.gov).

TAilored SToma policY after TME for rectal cancer: The TASTY approach.

AIM: Diverting stomas are routinely used in restorative surgery following total mesorectal exicision (TME) for rectal cancer to mitigate the clinical risks of anastomotic leakage (AL). However, routine diverting stomas are associated with their own complication profile and may not be required in all patients. A tailored approach based on personalized risk of AL and selective use of diverting stoma may be more appropriate. The aim of the TAilored SToma policY (TASTY) project was to design and pilot a standardized, tailored approach to diverting stoma in low rectal cancer. METHOD: A mixed-methods approach was employed. Phase I externally validated the anastomotic failure observed risk score (AFORS). We compared the observed rate of AL in our cohort to the theoretical, predicted risk of the AFORS score. To identify the subset of patients who would benefit from early closure of the diverting stoma using C-reactive protein (CRP) we calculated the Youden index. Phase II designed the TASTY approach based on the results of Phase I. This was evaluated within a second prospective cohort study in patients undergoing TME for rectal cancer between April 2018 and April 2020. RESULTS: A total of 80 patients undergoing TME surgery for rectal cancer between 2016 and 2018 participated in the external validation of the AFORS score. The overall observed AL rate in this cohort of patients was 17.5% (n = 14). There was a positive correlation between the predicted and observed rates of AL using the AFORS score. Using ROC curves, we calculated a CRP cutoff value of 115 mg/L on postoperative day 2 for AL with a sensitivity of 86% and a negative predictive value of 96%. The TASTY approach was designed to allocate patients with a low risk AFORS score to primary anastomosis with no diverting stoma and high risk AFORS score patients to a diverting stoma, with early closure at 8-14 days, if CRP values and postoperative CT were satisfactory. The TASTY approach was piloted in 122 patients, 48 (39%) were identified as low risk (AFORS score 0-1) and 74 (61%) were considered as high risk (AFORS score 2-6). The AL rate was 10% in the low-risk cohort of patient compared to 23% in the high-risk cohort of patients, p = 0.078 The grade of Clavien-Dindo morbidity was equivalent. The incidence of major LARS was lowest in the no stoma cohort at 3 months (p = 0.014). CONCLUSION: This study demonstrates the feasibility and safety of employing a selective approach to diverting stoma in patients with a low anastomosis following TME surgery for rectal cancer.