Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh With Primary Perineal Wound Closure After Extralevator Abdominoperineal Resection (BIOPEX-study).

OBJECTIVE: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia. SUMMARY BACKGROUND DATA: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing). METHODS: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic. RESULTS: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome. CONCLUSIONS: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.

Management of early rectal cancer; current surgical options and future direction.

Rectal cancer is the second commonest cause of cancer death within the United Kingdom. Utilization of national screening programmes have resulted in a greater proportion of patients presenting with early-stage disease. The technique of transanal endoscopic microsurgery was first described in 1984 following which further options for local excision have emerged with transanal endoscopic operation and, more recently, transanal minimally invasive surgery. Owing to the risks of local recurrence, the current role of minimally invasive techniques for local excision in the management of rectal cancer is limited to the treatment of pre-invasive disease and low risk early-stage rectal cancer (T1N0M0 disease). The roles of chemotherapy and radiotherapy for the management of early rectal cancer are yet to be fully established. However, results of high-quality research such as the GRECCAR II, TESAR and STAR-TREC randomised control trials may highlight a wider role for local excision surgery in the future, when used in combination with oncological therapies. The aim of our review is to provide an overview in the current management of early rectal cancer, the surgical options available for local excision and the future multimodal direction of early rectal cancer treatment.

Perineal hernia repair after abdominoperineal rectal excision with prosthetic mesh-a single surgeon experience.

AIM: Extralevator abdominoperineal excision for rectal cancer is associated with an increased incidence of perineal hernia. The purpose of this study was to determine clinical outcome following perineal hernia repair with prosthetic mesh by a perineal open approach. METHODS: We present a case series of 10 patients who underwent 12 repairs of their hernia using a prosthetic mesh placed by a perineal open technique. Patients were identified from a prospectively maintained database and their case records were retrieved along with their imaging and analysed retrospectively. RESULTS: Perineal hernia incidence in our series is 10%. The median age was 73 ± 5.9 years. No gender predilection was found. The median time interval between extralevator abdominoperineal excision and surgical repair of perineal hernia was 25.3 months. The surgical approach was perineal with the use of a double layer prosthetic mesh. The recurrence ratio was 30% (n = 3). Overall morbidity was also 30% with no major complications (Clavien-Dindo I-II). Recurrence following primary repair was diagnosed in a median time interval of 28.3 ± 16.57 months. Two patients had repeat surgery to treat their recurrence. CONCLUSIONS: Our small series supports the use of a prosthetic mesh repair of perineal hernias through a perineal approach. It is safe and effective with complication rates similar to those previously reported.

Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.

BACKGROUND: Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques. METHODS/DESIGN: MIRCAST is the Minimally-Invasive Right Colectomy Anastomosis Study that will compare laparoscopy with robot-assisted surgery, using either intracorporeal or extracorporeal anastomosis, in a large prospective, observational, multicenter, parallel, four-cohort study in patients with a benign or malignant, non-metastatic tumor of the right colon. Over 2 years of follow-up, the study will prospectively evaluate peri- and postoperative complications, postoperative recovery, hospital stay, and mid-term results including survival, local recurrence, metastases rate, and conversion rate. The primary composite endpoint will be the efficacy of the surgical method regarding surgical wound infections and postoperative complications (Clavien-Dindo grade III-IV complications at 30 days post-surgery). Secondary endpoints include long-term oncologic results, conversion rate, operative time, length of stay, and quality of life. DISCUSSION: This will be the first large, international study to prospectively evaluate the use of minimally-invasive laparoscopy or robot-assisted surgery during right hemicolectomy and to control for the impact of the anastomotic technique. The research will contribute to current knowledge regarding the medical care of patients with malignant or benign tumors of the right colon, and enable physicians to determine which technique may be the most appropriate for their patients. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov (clinicaltrials.gov identifier: NCT03650517 ) on August 28th 2018 (study protocol version CI18/02 revision A, 21 February 2018).

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study).

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Simultaneous stoma reinforcement and perineal reconstruction with biological mesh - A multicentre prospective observational study.

INTRODUCTION: The optimal method for perineal reconstruction after extralevator abdominoperineal excision (elAPE) for low rectal cancer remains controversial. This study aimed to assess whether simultaneous perineal reconstruction and parastomal reinforcement with Strattice™ Reconstructive Tissue Matrix after elAPE could prevent hernia formation. METHODS: In this prospective, multicentre, observational, non-comparative study of consecutive patients undergoing elAPE for low rectal cancer underwent simultaneous perineal reconstruction and colostomy site reinforcement with Strattice™ mesh. All patients underwent long course chemoradiotherapy prior to surgery and had excision of the coccyx. Patients were assessed for perineal wound healing at 7 day, 1, 3, 6 and 12 months, perineal and parastomal hernia defects on clinical and radiological assessment at 1 year following surgery. RESULTS: 19 patients (median age = 67 years, median BMI = 26, M:F = 11:8) were entered the study. 10 (52.6%) patients underwent laparoscopic elAPE. The median length of post-operative stay was 9 days. Complete wound healing was observed for 8(42%) patients at 1 month, 12(63%) at 3 months, and 19(100%) patients at 12 months. Median time for radiological and clinical assessment for hernias was 12 months. No perineal hernia was detected in 17 patients following CT assessment. Dynamic MRI was undertaken in 11 patients at 12 months and all showed no evidence of perineal hernia. 3 (16%) patients had a parastomal hernia detected radiologically. No mesh was removed during the 12 months follow up period. CONCLUSION: Perineal and parastomal reconstruction with biological mesh is a feasible approach for parastomal and perineal hernia prevention after laparoscopic and open elAPE.

Prospective Audit of a Pathway for In-Patient Pain Management of Chronic Abdominal Pain: A Novel and Cost-Effective Strategy.

Background: Unexplained abdominal pain is a common cause of hospital admission and utilizes significant resource. Current in-patient pain management of acute exacerbation of chronic abdominal pain is primarily directed at pharmacological and psychological management strategies in this group of complex patients. We adopted a novel approach that proved to be both clinically effective and cost-effective. Design: Adult patients admitted to a surgical ward with acute exacerbation of chronic abdominal pain referred to in-patient pain management were prospectively audited over a two-year period at a single tertiary centre. Methods: Management strategy focused on a somatic source as the predominant pain generator. Patients were offered ultrasound-guided trigger point injection with steroids within 48 hours of referral and were discharged when pain control was achieved. Subsequent care by the pain physician included targeted treatment of somatic component (repeated trigger point injection with steroids or pulsed radiofrequency treatment of trigger points). Results: We audited 43 patients referred to the inpatient pain management service over a two-year period. Four patients refused to undergo the diagnostic trigger point injection. Three patients with active visceral disease had a transient response to the injection. Thirty-six patients were diagnosed with abdominal myofascial pain syndrome, and two-thirds of these patients were discharged home within 36 hours of the intervention. Conclusions: Abdominal myofascial pain syndrome is a poorly recognized cause of chronic abdominal pain, especially in patients with a past history of visceral inflammation. The novel strategy resulted in a significant reduction in opioid consumption, length of stay, and readmission rate.

The "two-week wait" referral pathway is not associated with improved survival for patients with colorectal cancer.

AIM: To improve survival rates in patients diagnosed with cancer in the UK, a two-week wait (2ww) referral to first appointment target and a 62 day referral to treatment target were introduced in 2004. This study analyses survival rates for patients diagnosed with colorectal cancer (CRC) by mode of referral and referral to treatment time. METHOD: A prospectively maintained database of CRC outcomes at the University Hospitals of Leicester NHS Trust was analysed. Data for patients diagnosed with CRC was analysed for survival. Comparisons were made by mode of referral (2ww, urgent, routine, emergency, national bowel cancer screening programme (NBCSP) and other screening pathways). In addition, this study assessed referral to initial treatment times for patients undergoing cancer resection (<62days group vs. >62days group). Inter-group comparisons were made using the Mann-Whitney-U-test. Kaplan-Meier survival probability estimates were calculated for overall survival and the log-rank test was used to compare the survival distributions in different groups. RESULTS: Overall survival (median time) was significantly lower for patients referred by the '2ww' pathway (3.5 years, 95% CI: 2.7-4.30), in comparison to the 'routine' (5.4 years, 95% CI: 4.5-6.6) pathway (p < 0.001). Patients referred on the '2ww' pathway were 1.34 times more likely to have stage IV disease at presentation in comparison to patients referred by the 'routine' pathway. Comparison of referral to initial treatment times showed there was no significant difference in survival between the <62days group and the >62days group (7.1 vs. 6.54, p = 0.620). CONCLUSION: Patients diagnosed with CRC by the 2ww pathway had shorter survival times than those referred by a routine pathway.

A single institution's long-term follow-up of patients with pathological complete response in locally advanced rectal adenocarcinoma following neoadjuvant chemoradiotherapy.

PURPOSE: This paper aimed to study the long term follow-up of patients with primary rectal adenocarcinoma receiving neoadjuvant chemoradiotherapy who obtained a pathological complete response (pCR) and identify factors predicting complete response. METHODS: Retrospective review of notes, histology, pre-operative full blood count and imaging of patients with primary rectal adenocarcinoma diagnosed in our institute from 2000 to 2012 from a prospectively maintained database were used. SPSS version 22.0 was used for statistical analysis. RESULTS: Three hundred eighty patients diagnosed with primary rectal adenocarcinoma were identified, 277 received neoadjuvant chemoradiotherapy followed by curative resection. Forty-six patients obtained a pCR (ypT0N0) with no local recurrence and two metastatic recurrences on follow-up. Patients with a pCR have a significantly improved overall survival and disease-free survival compared to a non-pCR (150.0 and 136.1 vs 77.5 and 84.7 months, p = 0.001). On univariate analysis, increased tumour height above anal verge, low lymph node yield, high pre-operative haemoglobin and a low neutrophil-lymphocyte ratio are significant factors identifying a pCR. Multivariable analysis of the above factors confirmed tumour height above anal verge as significant in obtaining a pCR. CONCLUSION: Patients with rectal adenocarcinoma who develop a pCR following neoadjuvant chemoradiotherapy have improved overall and disease-free survival. We have identified distance from anal verge, low lymph node yield, high pre-operative haemoglobin and low neutrophil-lymphocyte ratio as significant predictors of developing a pCR.

Enhanced recovery programmes in colorectal surgery are less enhanced later in the week: An observational study.

OBJECTIVES: Since the introduction and favourable early results of the enhanced recovery programme more than a decade ago, it has become increasingly popular following major abdominal surgery. The programme has now been adopted in the UK. The aim of our study was to see if the day of surgery affected hospital stay and we compared patients who had colorectal surgery early in the week (Monday to Wednesday) with those who had it later in the week (Thursday to Friday). DESIGN: Patient outcomes were studied between May 2010 and April 2011 from a prospectively maintained database. All colorectal surgeons involved in the enhanced recovery programme in our unit have a flexible rota and so no surgeon was operating on a particular day to avoid bias. An enhanced recovery programme protocol was utilised for all the patients with no bowel preparation, early feeding and early mobilisation. SETTING: Study was carried out at the University Hospitals of Leicester. PARTICIPANTS: Patients undergoing elective colorectal resection between Monday and Friday. MAIN OUTCOME MEASURE: Hospital stay. RESULTS: Two hundred and twenty-seven patients underwent surgery and were on the enhanced recovery programme during this period. Two (0.9%) patients who had surgery on a Sunday were excluded. Two hundred and twenty-five patients were analysed of which 155 (69%) were in the group (Monday to Wednesday) and 70 (31%) in the group (Thursday to Friday). No significant differences were observed amongst the groups for age (p = 0.129), sex (p = 0.555), tumour location (p = 0.140), operation performed (p = 0.127), type of surgery (laparoscopy or open, p = 0.892), complications (p = 0.428). However, a significant shorter length of stay was present in the first group six days (interquartile range: 4-10) versus eight days (interquartile range: 5-11) (p = 0.045). CONCLUSION: Operating on colorectal patients early in the week is associated with a significant decreased hospital stay. This should be put into consideration by units practising enhanced recovery programme if the maximal benefit of this is to be attained.

Perineal reconstruction after extra-levator abdominoperineal excision (eLAPE): a systematic review.

PURPOSE: Extra-levator abdominal perineal excision of rectum (eLAPE) for low rectal tumours is associated with a lower incidence of circumferential resection involvement. However, there is no consensus on the ideal technique for perineal reconstruction following eLAPE. We thereby conducted a 5-year review of perineal closure outcomes following eLAPE. METHODS: A systematic review of the literature was conducted between 2006 and July 2012. Perineal wound healing and complications in the post-operative period were examined. RESULTS: Original data following eLAPE were found in 27 studies involving 963 individuals to inform a qualitative synthesis. Pooled analysis revealed that investigators most commonly employed either biomesh closure (12 studies, n = 149), myocutaneous flap closure (9 studies, n = 201) and primary closure (4, n = 578). The incidence of minor and major wound complications and perineal hernias across the latter groups was (27.5, 13.4 and 2.7 %), (29.4, 19.4 and 0 %) and (17.1, 6.4 and 1.2 %), respectively. Two studies utilised synthetic mesh closure (n = 4) and omentoplasty (n = 31). Objective assessment of wound healing was strikingly deficient across most studies, largely due to low level retrospective evidence lacking randomised controls. Modest cohort sizes with short follow-up data were evident due to the relative novelty of eLAPE. CONCLUSION: The paucity of high quality data, suggests that a prospective, randomised trial is needed to determine the ideal technique for perineal reconstruction following eLAPE.

Curative colorectal resections in patients aged 80 years and older: clinical characteristics, morbidity, mortality and risk factors.

BACKGROUND: The management of colorectal cancer in the elderly presents unique challenges. The objective of this study was to determine outcomes following curative colorectal resection in patients aged 80 years and older. PATIENTS AND METHODS: Study design is retrospective. Data were extracted from the university hospital database and medical records of patients aged 80 years and older operated between April 2004 and December 2009. Intervention was curative colorectal resection. Main outcome measures include postoperative morbidity, mortality and individual risk factors associated with them. RESULTS: Three hundred fifty-eight patients (43.8% males, age = 84 ± 3 years) were included; 72.6% received elective surgery. A significantly higher complication rate and 30 day, 1 year and 4 year mortality were present for emergency operations compared to elective (p < 0.001). One-year survival was 65.0% for elective resections and 55.1% for emergency. At 4 years of follow-up, survival was 49.2% for the elective vs. 27.6% for emergency. The American Society of Anesthesiologists (ASA) score is the only factor associated with the 30-day mortality at the multivariate analysis (p < 0.01), Dukes staging with overall mortality (p < 0.005), sex and mode of the operation with major complications (p < 0.05). A limitation of the study is that is retrospective. CONCLUSIONS: The highest mortality rates following colorectal surgery in the elderly are in the early postoperative period, especially for emergency operations and patients with significant comorbidities. However, the 1-year survival following elective curative resection for colorectal cancer approaches 65 %. ASA score and modality of the operation (elective vs. emergency) impacted on postoperative mortality and morbidity and could be used to select patients with more favourable outcomes.

Successful voiding after trial without catheter is not synonymous with recovery of bladder function after colorectal surgery.

PURPOSE: The need for monitoring postoperative urine output and the possibility of lower urinary tract dysfunction following colorectal surgery necessitates temporary urinary drainage. Current practice assumes recovery of lower urinary tract function to coincide with successful micturition after removal of urethral catheter. The aim of this study was to analyze the recovery of bladder function following colorectal surgery. METHODS: Patients undergoing colorectal operations underwent preoperative and postoperative uroflowmetry and residual urine estimation. All patients were catheterized suprapubically at surgery. Uroflowmetry and postvoid residual volumes were recorded postoperatively until recovery of bladder function was complete. RESULTS: Thirty consecutive patients underwent suprapubic catheterization, 25 of whom completed the study. Seventeen (68 percent) patients were able to pass urine within 72 hours of surgery. Recovery of lower urinary tract function was delayed in patients undergoing rectal vs. colonic resections (median, 6 vs. 3 days, P = 0.0015). Postvoid residual volumes greater than 200 ml were noted in three (20 percent) patients following rectal resections beyond the tenth postoperative day, with complete emptying achieved by six weeks. CONCLUSIONS: Apparent successful micturition following rectal resections does not always indicate recovery of bladder function. The use of suprapubic catheters, in addition to being safe and effective, allows assessment of residual volumes postoperatively and smoothes the path to full recovery of lower urinary tract function.

Preoperative intensive, community-based vs. traditional stoma education: a randomized, controlled trial.

PURPOSE: Conventional practice in colorectal surgery involves stoma education being imparted postoperatively. Proficiency in stoma management often delays patients' discharge following colorectal surgery. The aim of this randomized, controlled trial was to compare preoperative intensive, community-based stoma education with conventional postoperative stoma education after elective colorectal surgery. METHODS: Forty-two elective colorectal patients requiring a stoma were randomized into an intensive preoperative teaching (study) or postoperative (control) group. Intervention for the study group included two preoperative visits in the community during which patients were taught with audiovisual aids to use and change the stoma pouching system. Goal-directed postoperative stoma education was standardized for both groups. Outcomes measured included time to stoma proficiency, postoperative hospital stay, unplanned stoma-related interventions in the community within six weeks of discharge, and preoperative and postoperative hospital anxiety and depression scores. Cost-effectiveness of the intervention was also evaluated. RESULTS: All outcomes measured were improved in the study group, including time to stoma proficiency (5.5 vs. 9 days; P = 0.0005), hospital stay (8 vs. 10 days; P = 0.029), and unplanned stoma-related community interventions per patient (median 0 vs. 0.5; P = 0.0309). No adverse effects of the intervention were noted. The average cost saving per patient was pound 1,119 (dollar 2,104) for the study group compared with the control group. CONCLUSIONS: Stoma education is more effective if undertaken in the preoperative setting. It results in shorter times to stoma proficiency and earlier discharge from the hospital. It also reduces stoma-related interventions in the community and has no adverse effects on patient well-being.