Clinical management of high-output stoma: a systematic literature review and meta-analysis.

PURPOSE: High output is a common complication after stoma formation. Although the management of high output is described in the literature, there is a lack of consensus on definitions and treatment. Our aim was to review and summarise the current best evidence. METHODS: MEDLINE, Cochrane Library, BNI, CINAHL, EMBASE, EMCARE, and ClinicalTrials.gov were searched from 1 Jan 2000 to 31 Dec 2021 for relevant articles on adult patients with a high-output stoma. Patients with enteroatmospheric fistulas and case series/reports were excluded. Risk of bias was assessed using RoB2 and MINORS. The review was registered in PROSPERO (CRD42021226621). RESULTS: The search strategy identified 1095 articles, of which 32 studies with 768 patients met the inclusion criteria. These studies comprised 15 randomised controlled trials, 13 non-randomised prospective trials, and 4 retrospective cohort studies. Eighteen different interventions were assessed. In the meta-analysis, there was no difference in stoma output between controls and somatostatin analogues (g - 1.72, 95% CI - 4.09 to 0.65, p = 0.11, I2 = 88%, t2 = 3.09), loperamide (g - 0.34, 95% CI - 0.69 to 0.01, p = 0.05, I2 = 0%, t2 = 0) and omeprazole (g - 0.31, 95% CI  - 2.46 to 1.84, p = 0.32, I2 = 0%, t2 = 0). Thirteen randomised trials showed high concern of bias, one some concern, and one low concern. The non-randomised/retrospective trials had a median MINORS score of 12 out of 24 (range 7-17). CONCLUSION: There is limited high-quality evidence favouring any specific widely used drug over the others in the management of high-output stoma. Evidence, however, is weak due to inconsistent definitions, risk of bias and poor methodology in the existing studies. We recommend the development of validated core descriptor and outcomes sets, as well as patient-reported outcome measures.

Long-term follow-up of bilateral gracilis reconstruction following extra-levator abdominoperineal excision.

INTRODUCTION: Colorectal operations such as an extra-levator abdominoperineal (elAPE) excision for locally advanced or recurrent cancer create a significant perineal tissue deficit. Options for perineal reconstruction include bilateral pedicled gracilis muscle flaps (BPGMF). Fashioning the gracili into a 'weave' creates a muscular sling that supports pelvic contents and is a novel technique. Our series reports the outcomes of the BPGMF in 50 patients undergoing surgery for pelvic cancer. METHOD: This is a retrospective, single-centre study of patients undergoing reconstruction of perineal defects using BPGMF. All surgeries took place between January 2008 and February 2021. The primary outcome measured was perineal wound healing. The secondary outcomes measured were complications of surgical sites and length of hospital stay (short term), flap integrity on follow-up imaging and functional outcomes (long term). RESULTS: Fifty patients underwent perineal reconstruction using BPGMF (26 males). The median age was 62 years. The 30-day mortality was 2% (n = 1). The average follow-up period was 2 years. Complete perineal wound healing was 86% (42/49) at outpatient follow-up. Complication rates for the donor site and reconstructed site were 14% and 22%, respectively. Complications included infection (2% donor site, 12% perineum), haematoma (4% donor site), dehiscence (2% donor site, 4% perineum) and seroma (3% donor site, 2% perineum). CONCLUSION: BPGMF offers a reliable and technically simple muscle flap to reconstruct large perineal defects. The muscle flap integrity appears maintained on follow-up imaging despite a lack of flap monitoring tools. This cohort had minimal functional impairment following BPGMF.

An internal pilot study of a novel rectal mucocellular sampling device to allow next-generation sequencing for colorectal disease.

BACKGROUND: The ORI-EGI-02 study was designed to test the hypothesis that rectal mucus collected using a novel rectal sampling device (OriCol™), contains sufficient human deoxyribonucleic acid (DNA) of the required quality for Next Generation Sequencing (NGS), for colorectal disease genetic signature discovery. METHODS: Using National Institute for Health and Care Research methodology, an internal pilot study was performed in January 2020-May 2021, at four sites in the United Kingdom, to assess the process of recruitment, consent, specimen acquisition and viability for analysis. Following an OriCol™ test, the sample was stabilized with a buffer solution to preserve the material, which was posted to the laboratory. Samples were processed using QIAamp® DNA Blood Midi kit to extract DNA and Quant-iT™ PicoGreen® dsDNA Reagent to quantify the retrieved DNA. DNA integrity was measured by Agilent TapeStation system. 25 ng of human amplifiable DNA was prepared for Next Generation Sequencing (NGS), which was performed on an Illumina NextSeq550 sequencer using the 300-cycle high output kit v2.5. RESULTS: This study assessed the first 300 patients enrolled to the ORI-EGI-02 Study (n = 800). 290/300 (96.67%) were eligible to undergo OriCol™ sampling procedure and 285/290 (98.27%) had a successful OriCol™ sample taken. After transportation, extraction and quantification of DNA, 96.20% (279/290) of the samples had NGS successfully performed for bioinformatic analysis. CONCLUSIONS: Our internal pilot study demonstrated that the OriCol™ sampling device can capture rectal mucus from unprepared bowel in subjects who could undergo a digital rectal examination. The technique could be applied irrespective of age, frailty, or co-morbidity. Completion of the study to 800 patients and analysis of NGS data for colorectal cancer mutations will now proceed.

What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention.

OBJECTIVES: To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma formation. DESIGN: (1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplemented by (2) intraoperative qualitative research (observations, videos and interviews), to identify unreported variations used in practice to generate (3) a 'long list' of items, which were rationalised using (4) consensus methods, providing a pragmatic list of CRF items to be captured in the Cohort study to Investigate the Prevention of parastomal HERnias (CIPHER) study. SETTING: Two secondary care surgical centres in England. PARTICIPANTS: Patients undergoing stoma formation, surgeons undertaking stoma formation and stoma nurses. OUTCOME MEASURES: Successful identification of key CRF items to be captured in the CIPHER study. RESULTS: 59 data items relating to stoma formation were identified and categorised within six themes: (1) surgical approach to stoma formation; (2) trephine formation; (3) reinforcing the stoma trephine with mesh; (4) use of the stoma as a specimen extraction site; (5) closure of other wounds during the procedure; and (6) spouting the stoma. CONCLUSIONS: This study used multimodal data collection to understand and capture the technical variations in stoma formation and design bespoke CRFs for a multicentre cohort study. The CIPHER study will use the CRFs to examine associations between the technical variations in stoma formation and risks of developing a parastomal hernia. TRIAL REGISTRATION NUMBER: ISRCTN17573805.

Preoperative assessment and optimisation for pelvic exenteration in locally advanced and recurrent rectal cancer: A review.

The pre-operative phase in planning a pelvic exenteration or extended resections is critical to optimising patient outcomes. This review summarises the key components of preoperative assessment and planning in patients with locally advanced rectal cancer (LARC) and locally recurrent rectal cancer (LLRC) being considered for potential curative resection. The preoperative period can be considered in 5 key phases: 1) Multidisciplinary meeting (MDT) review and recommendation for neoadjuvant therapy and surgery, 2) Anaesthetic preoperative assessment of fitness for surgery and quantification of risk, 3) Shared decision making with the patient and the process of informed consent, 4) Prehabilitation and physiological optimisation 5) Technical aspects of surgical planning. This review will focus on patients who have been recommended for surgery by the MDT and have completed neoadjuvant therapy. Other important considerations beyond the scope of this review are the various neoadjuvant strategies employed which in this patient group include Total Neo-adjuvant Therapy and reirradiation. Critical to improving perioperative outcomes is the dual aim of achieving a negative resection margin in a patient fit enough for extended surgery. Advanced, realistic communication is required pre-operatively and should be maintained throughout recovery. Optimising patient's physiological and psychological reserve with a preoperative prehabilitation programme is important, with physiotherapy, psychological and nutritional input. From a surgical perspective, image based technical preoperative planning is important to identify risk points and ensure correct surgical strategy. Careful attention to the entire patient journey through these 5 preoperative phases can optimise outcomes with the accumulation of marginal gains at multiple timepoints.

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation.

BACKGROUND: Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence. METHODS: A systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality. RESULTS: Twelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool. CONCLUSION: The evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.

Outcomes of surgically managed recurrent parastomal hernia: the Sisyphean challenge of the hernia world.

PURPOSE: The management of a recurrent (symptomatic) parastomal hernia (PSH) presents a dilemma. The aim of this study was to review the outcome of patients who underwent a recurrent PSH repair. METHODS: Retrospective review of consecutive patients undergoing recurrent PSH repairs at a single institution between 2010 and 2019. Primary outcome recorded was recurrence. Secondary outcomes recorded were 30-day post-operative complications, surgical site occurrence (SSO) incidence and to assess if EHS classification altered with each recurrence. RESULTS: Thirty-eight patients underwent 59 recurrent PSH repairs during the study period. Median number of PSH repairs per patient from ostomy formation was 2 (2-8). Post-operative complications occurred following 52.5% of repairs. Recurrence rate for all recurrent PSH hernia repairs was 45.7%, with a median follow-up of 58 months (0-115). A trend was seen towards a shorter PSH recurrence-free survival in those who had at least two previous PSH repairs at the start of the study period when compared to those who had less. Recurrence was not associated with operative urgency, type of repair, mesh type or SSO occurrence. A significant decrease in recurrence was seen with retro-rectus mesh placement when compared to onlay (p = 0.003). EHS classification did not change between each recurrence in 70.8% of patients. CONCLUSION: Recurrence rates after recurrent PSH repair are high. The recurrence-free survival was worse after the second or more attempt at repair for recurrence. Further studies are warranted to explore prophylaxis, optimal repair method, and where re-recurrence occurs, the benefit of repeated surgical intervention.

Single centre experience of bilateral gracilis flap perineal reconstruction following extra-levator abdominoperineal excision.

AIM: A variety of tissue flaps have been described for the closure of perineal wounds following abdominoperineal excision of the rectum (APE) or exenteration for locally advanced/recurrent rectal cancer and salvage surgery for anal cancer. The aim of this study was to demonstrate the utility of the bilateral pedicled gracilis muscle flaps (BPGMFs) as a reconstruction option in these patients. This is of particular benefit when using a laparoscopic approach for the abdominal component of the operation, avoiding disruption of the abdominal wall and risk of herniation with other reconstruction options, e.g. vertical rectus abdominis myocutaneous flaps. METHOD: This is a retrospective single centre case series of patients who underwent reconstruction of perineal defects using BPGMFs using a novel weave technique, from January 2008 to August 2017. RESULTS: There were 25 patients (16 female), with a median follow-up of 19 months (3-102). The indications for BPGMFs were cancer resection (21) and perineal hernia (4). The median length of stay was 14 days (6-60). All-cause mortality was 36% within the follow-up period. A healed perineal wound was achieved in 72% of patients within 30 days (84% of patients received neoadjuvant chemoradiotherapy). The overall donor site complication rate was 20% (including infection, dehiscence, numbness, haematoma and seroma) and 28% for the perineal site (including infection, dehiscence and prolapse). CONCLUSIONS: BPGMFs provide an important option for reconstruction of the perineum particularly with a minimally invasive approach or with two stomas.

Radiological progression of end colostomy trephine diameter and area.

Background: Development of a parastomal hernia is common following abdominoperineal excision (APE). The true incidence is difficult to assess fully owing to differing lengths of follow-up and techniques used to assess herniation; radiological or clinical. The primary aim of this study was to evaluate colostomy diameter by studying the rate of change of axial and sagittal trephine diameters, trephine area, and the ratio of the trephine over time. A secondary aim was to investigate variation in trephine area and variables affecting parasternal hernia over time. Methods: Serial CT scans performed after APE from January 2006 to December 2014 were reviewed. Variables analysed included age, sex, trephine position relative to rectus abdominis muscle (RAM), type of incision for stoma creation, and axial and sagittal trephine diameters measured on follow-up CT. A Bayesian hierarchical modelling framework was used to examine the relationship of trephine diameters, area and ratio over time. Results: Of 112 patients undergoing APE, 103 were eligible for analysis; this included 91 colostomies (88·3 per cent) through the RAM and 12 (11·7 per cent) lateral to the RAM. Median age of the patients was 68 years. Sixty patients (58·3 per cent) had a circular and 43 (41·7 per cent) a cruciate incision for stoma creation. The sagittal trephine diameter increased by 0·22 (95 per cent credible interval 0·12 to 0·32) mm/month for both sexes. Women reported a significant increase in axial trephine diameters; the male : female ratio difference was -0·17 (-0·30 to -0·03) mm/month and for trephine areas -6·21 (0·96 to 13·7) mm2/month. Patient age, colostomy trephine location and shape of incision were not statistically significant variables for parasternal hernia. Conclusion: Female sex was the only variable affecting the rate of increase in axial trephine diameter and trephine area over time.

What is the evidence for the use of biologic or biosynthetic meshes in abdominal wall reconstruction?

INTRODUCTION: Although many surgeons have adopted the use of biologic and biosynthetic meshes in complex abdominal wall hernia repair, others have questioned the use of these products. Criticism is addressed in several review articles on the poor standard of studies reporting on the use of biologic meshes for different abdominal wall repairs. The aim of this consensus review is to conduct an evidence-based analysis of the efficacy of biologic and biosynthetic meshes in predefined clinical situations. METHODS: A European working group, "BioMesh Study Group", composed of invited surgeons with a special interest in surgical meshes, formulated key questions, and forwarded them for processing in subgroups. In January 2016, a workshop was held in Berlin where the findings were presented, discussed, and voted on for consensus. Findings were set out in writing by the subgroups followed by consensus being reached. For the review, 114 studies and background analyses were used. RESULTS: The cumulative data regarding biologic mesh under contaminated conditions do not support the claim that it is better than synthetic mesh. Biologic mesh use should be avoided when bridging is needed. In inguinal hernia repair biologic and biosynthetic meshes do not have a clear advantage over the synthetic meshes. For prevention of incisional or parastomal hernias, there is no evidence to support the use of biologic/biosynthetic meshes. In complex abdominal wall hernia repairs (incarcerated hernia, parastomal hernia, infected mesh, open abdomen, enterocutaneous fistula, and component separation technique), biologic and biosynthetic meshes do not provide a superior alternative to synthetic meshes. CONCLUSION: The routine use of biologic and biosynthetic meshes cannot be recommended.

Incisional hernia following closure of loop ileostomy: The main predictor is the patient, not the surgeon.

BACKGROUND: Incisional hernia at the ileostomy site occurs in 0-48% of patients undergoing loop ileostomy closure. Risk factors for ileostomy-site hernia are not currently well understood. We explored the predictive value of patient and clinical factors for ileostomy-site hernias. METHOD: Loop ileostomy reversals undertaken between 1st January 2009 and 31st December 2013 were retrospectively evaluated. Preoperative patient data (BMI, age, gender, blood pressure, diabetes), surgical variables (preoperative ileostomy marking, intraoperative management (suture type, closure method), postoperative complications (≤30 days), approach, urgency, and chemotherapy, hospital stay, stoma closure interval, follow-up duration) were collected. Patients were followed up by clinical examination and postoperative imaging. RESULTS: 193 loop ileostomy reversals were identified. Operative indications included: colorectal cancer (n = 102, 52.8%); inflammatory bowel disease (n = 47, 24.3%); diverticulosis (n = 20, 10.4%); assorted indications (n = 19, 9.8%); and inflammatory fistulae (n = 5, 2.6%). Median duration of clinical follow-up was 20.5 months (0-69). Hernia occurred in 26 patients (13.5%), detected at a median of eight months post-reversal. Radiological follow-up occurred in 72% of patients and, as a reference standard, in 100% of patients diagnosed with a hernia. Concordance between clinical and radiological findings was 88.5%. Postoperative complications predicted higher hernia risk. BMI and preoperative blood pressure were significant hernia predictors. Differences in the type of suture material to close the defect (absorbable vs. non-absorbable) and stoma skin closure method (primary vs. secondary intention healing) were non-predictive of hernia. CONCLUSION: Whilst BMI and patient comorbidity are the major hernia predictors, variability in surgical practice does not constitute a significant risk factor for ileostomy-site incisional hernia.

The use of adjuncts to reduce seroma in open incisional hernia repair: a systematic review.

BACKGROUND: Seroma formation remains a common complication after an incisional hernia repair. The use of surgical drains is widespread, but evidence for their use and other adjuncts is limited. Our aim was to perform a systematic review of the literature on techniques used to reduce the incidence of post-operative seroma formation. METHODS: A systematic search of PubMed and Embase databases was conducted using terms including "incisional hernia" and "seroma". All studies on adults undergoing open incisional hernia repair with at least one intervention designed to reduce seroma formation were included. RESULTS: Of the 1093 studies identified, 9 met the inclusion criteria. Medical talc: one cohort study of 74 patients undergoing talc application following pre-peritoneal mesh placement found a significantly decreased rate of seroma formation of 20.8 versus 2.7% (p < 0.001), but a retrospective study including 21 patients with onlay mesh found an increased rate of 76% seroma formation from 9.5% (p = 0.001). Fibrin glue: one comparative study including 60 patients found a reduction in seroma formation from 53 to 10% (p = 0.003), whereas a retrospective study of 250 patients found no difference (11 vs. 4.9% p = 0.07). Negative pressure wound therapy: four retrospective studies including a total of 358 patients found no difference in seroma outcome. Others: one randomised study of 42 patients undergoing either suction drainage or "quilting" sutures found no difference in seroma formation. CONCLUSIONS: There is currently insufficient quality evidence to recommend any of the investigated methods, some of which incur significant additional cost.

Systematic review and meta-analysis of the role of metronidazole in post-haemorrhoidectomy pain relief.

AIM: Conventional haemorrhoidectomy is still considered the reference standard for the management of severe or recurrent haemorrhoids. Pain is reported by patients to be the most common postoperative complication. Although the literature lacks a consensus on its effectiveness, metronidazole is often used to reduce postoperative pain. We have performed a meta-analysis of all randomized controlled trials (RCTs) that investigated the use of metronidazole for pain relief after haemorrhoidectomy. METHOD: A systematic review was undertaken in accordance with the PRISMA protocol using the MESH headings 'haemorrhoidectomy', 'hemorhoidectomy', 'hemorrhoidectomy', 'haemorrhoid', 'metronidazole', 'Flagyl® ' 'antibiotic' and 'pain'. The search returned 421 articles of which eight were RCTs suitable for inclusion in the review with a total population of 437 patients. The outcomes of interest were postoperative pain intensity on days 1, 2 and 7 and on first defaecation as measured using a visual analogue scale. RESULTS: The meta-analysis demonstrated a significant reduction in postoperative pain for patients treated with metronidazole with a reduced mean difference for the metronidazole group on day 1 of -1.42 (95% CI: -2.14 to -0.69, P = 0.0001), on day 2 of -1.43 (95% CI: -2.45 to -0.40, P = 0.006) and on day 7 of -2.40 (95% CI: -3.10 to -1.71, P < 0.00001). Pain on first defaecation was likewise reduced with a mean difference of -1.38 (95% CI: -2.15 to -0.60, P = 0.0005). Limitations of this study include variation in the grade of haemorrhoids treated and variability in the quality of included studies. CONCLUSION: Metronidazole is a cheap, safe and effective intervention for reducing postoperative pain following conventional haemorrhoidectomy.

Predicting response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer with serum biomarkers.

Introduction The aim of this study was to identify patient factors including serum biomarkers that may predict response to neoadjuvant chemoradiotherapy (CRT) in patients with locally advanced rectal cancer staged on magnetic resonance imaging. Prediction of response may be helpful when selecting patients for a non-operative programme. Methods A retrospective review was carried out of patients undergoing neoadjuvant CRT for rectal cancer, conducted at the Royal Devon and Exeter Hospital. All patients were managed through the multidisciplinary team. Receiver operating characteristic (ROC) curve analysis was undertaken to assess the ability of biomarkers to predict response to neoadjuvant CRT. The biomarkers assessed included neutrophils, lymphocytes, monocytes, haemoglobin, platelets, C-reactive protein and carcinoembryonic antigen. Results Seventy-three patients underwent neoadjuvant CRT between January 2006 and December 2011. Nine (12.3%) of these experienced a clinical complete response and were managed with a 'watch and wait' approach. An additional ten patients (13.7%) had a pathological complete response following surgery. Using ROC curve analysis, the biomarkers with the largest area under the curve (AUC) were pre-CRT haemoglobin and post-CRT lymphocyte concentrations, producing AUC values of 0.673 and 0.618 respectively for clinical complete response. Pre-CRT haemoglobin and neutrophil concentrations produced the highest AUC values for pathological complete response at 0.591 and 0.614 respectively. Conclusions None of the assessed biomarkers offer the ability to predict response to neoadjuvant CRT in patients with rectal cancer. They cannot therefore assist in identifying complete clinical or pathological responders who could be considered for a non-operative, observational approach.

Prophylactic mesh use during primary stoma formation to prevent parastomal hernia.

Introduction Parastomal hernia (PSH) is a common problem following stoma formation. The optimal technique for stoma formation is unknown although recent studies have focused on whether placement of prophylactic mesh at stoma formation can reduce PSH rates. The aim of this study was to systematically review use of prophylactic mesh versus no mesh with regard to occurrence of PSH and peristomal complications. Methods A systematic search was performed using PubMed, Embase™ and the Cochrane Library to identify randomised controlled trials that analysed placement of prophylactic mesh versus no mesh at time of initial surgery. Meta-analysis was performed using random effects methods. Results A total of 506 studies were identified by our search strategy. Of these, 8 studies were included, involving 430 patients (217 mesh vs 213 no mesh). Prophylactic mesh placement resulted in a significantly lower rate of PSH formation (42/217 [19.4%] vs 92/213 [43.2%]) with a combined risk ratio of 0.40 (95% confidence interval [CI]: 0.21-0.75, p=0.004). Placement of prophylactic mesh did not result in increased peristomal complications (15/218 [6.9%] vs 16/227 [7.0%]) with a combined risk ratio of 1.0 (95% CI: 0.49-2.01, p=0.990). Conclusions Prophylactic placement of mesh at primary stoma formation may reduce the incidence of PSH, without an increase in peristomal complications. However, the overall quality of the randomised controlled trials included in the meta-analysis was poor, and should prompt caution regarding the applicability of the findings of the individual studies and the meta-analysis to everyday practice.