Quality-of-life outcomes in older patients with early-stage rectal cancer receiving organ-preserving treatment with hypofractionated short-course radiotherapy followed by transanal endoscopic microsurgery (TREC): non-randomised registry of patients unsuitable for total mesorectal excision.

BACKGROUND: Older patients with early-stage rectal cancer are under-represented in clinical trials and, therefore, little high-quality data are available to guide treatment in this patient population. The TREC trial was a randomised, open-label feasibility study conducted at 21 centres across the UK that compared organ preservation through short-course radiotherapy (SCRT; 25 Gy in five fractions) plus transanal endoscopic microsurgery (TEM) with standard total mesorectal excision in adults with stage T1-2 rectal adenocarcinoma (maximum diameter ≤30 mm) and no lymph node involvement or metastasis. TREC incorporated a non-randomised registry offering organ preservation to patients who were considered unsuitable for total mesorectal excision by the local colorectal cancer multidisciplinary team. Organ preservation was achieved in 56 (92%) of 61 non-randomised registry patients with local recurrence-free survival of 91% (95% CI 84-99) at 3 years. Here, we report acute and long-term patient-reported outcomes from this non-randomised registry group. METHODS: Patients considered by the local colorectal cancer multidisciplinary team to be at high risk of complications from total mesorectal excision on the basis of frailty, comorbidities, and older age were included in a non-randomised registry to receive organ-preserving treatment. These patients were invited to complete questionnaires on patient-reported outcomes (the European Organisation for Research and Treatment of Cancer Quality of Life [EORTC-QLQ] questionnaire core module [QLQ-C30] and colorectal cancer module [QLQ-CR29], the Colorectal Functional Outcome [COREFO] questionnaire, and EuroQol-5 Dimensions-3 Level [EQ-5D-3L]) at baseline and at months 3, 6, 12, 24, and 36 postoperatively. To aid interpretation, data from patients in the non-randomised registry were compared with data from those patients in the TREC trial who had been randomly assigned to organ-preserving therapy, and an additional reference cohort of aged-matched controls from the UK general population. This study is registered with the ISRCTN registry, ISRCTN14422743, and is closed. FINDINGS: Between July 21, 2011, and July 15, 2015, 88 patients were enrolled onto the TREC study to undergo organ preservation, of whom 27 (31%) were randomly allocated to organ-preserving therapy and 61 (69%) were added to the non-randomised registry for organ-preserving therapy. Non-randomised patients were older than randomised patients (median age 74 years [IQR 67-80] vs 65 years [61-71]). Organ-preserving treatment was well tolerated among patients in the non-randomised registry, with mild worsening of fatigue; quality of life; physical, social, and role functioning; and bowel function 3 months postoperatively compared with baseline values. By 6-12 months, most scores had returned to baseline values, and were indistinguishable from data from the reference cohort. Only mild symptoms of faecal incontinence and urgency, equivalent to less than one episode per week, persisted at 36 months among patients in both groups. INTERPRETATION: The SCRT and TEM organ-preservation approach was well tolerated in older and frailer patients, showed good rates of organ preservation, and was associated with low rates of acute and long-term toxicity, with minimal effects on quality of life and functional status. Our findings support the adoption of this approach for patients considered to be at high risk from radical surgery. FUNDING: Cancer Research UK.

The first international Delphi consensus statement on Laparoscopic Gastrointestinal surgery.

BACKGROUND: Laparoscopic surgery has almost replaced open surgery in many areas of Gastro-Intestinal (GI) surgery. There is currently no published expert consensus statement on the principles of laparoscopic GI surgery. This may have affected the training of new surgeons. This exercise aimed to achieve an expert consensus on important principles of laparoscopic GI surgery. METHODS: A committee of 38 international experts in laparoscopic GI surgery proposed and voted on 149 statements in two rounds following a strict modified Delphi protocol. RESULTS: A consensus was achieved on 133 statements after two rounds of voting. All experts agreed on tailoring the first port site to the patient, whereas 84.2% advised avoiding the umbilical area for pneumoperitoneum in patients who had a prior midline laparotomy. Moreover, 86.8% agreed on closing all 15 mm ports irrespective of the patient's body mass index. There was a 100% consensus on using cartridges of appropriate height for stapling, checking the doughnuts after using circular staplers, and keeping the vibrating blade of the ultrasonic energy device in view and away from vascular structures. An 84.2% advised avoiding drain insertion through a ≥10 mm port site as it increases the risk of port-site hernia. There was 94.7% consensus on adding laparoscopic retrieval bags to the operating count and ensuring any surgical specimen left inside for later removal is added to the operating count. CONCLUSION: Thirty-eight experts achieved a consensus on 133 statements concerning various aspects of laparoscopic GI Surgery. Increased awareness of these could facilitate training and improve patient outcomes.

Early salvage total mesorectal excision (sTME) after organ preservation failure in rectal cancer does not worsen postoperative outcomes compared to primary TME: systematic review and meta-analysis.

IMPORTANCE: While oncological outcomes of early salvage total mesorectal excision (sTME) after local excision (LE) have been well studied, the impact of LE before TME on postoperative outcomes remains unclear. We aimed to compare early sTME with a primary TME for rectal cancer. METHODS: Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines with the random-effects model were adopted using Review Manager Version 5.3 for pooled estimates. RESULTS: We retrieved eleven relevant articles including 1728 patients (350 patients in the sTME group and 1438 patients in the TME group). There was no significant difference between the two groups in terms of mortality (OR = 0.90, 95%CI [0.21 to 3.77], p = 0.88), morbidity (OR = 1.19, 95%CI [0.59 to 2.38], p = 0.63), conversion to open surgery (OR = 1.34, 95%CI [0.61 to 2.94], p = 0.47), anastomotic leak (OR = 1.38, 95%CI [0.50 to 3.83], p = 0.53), hospital stay (MD = 0.23 day, 95%CI [- 1.63 to 2.10], p < 0.81), diverting stoma rate (OR = 0.69, 95%CI [0.44 to 1.09], p = 0.11), abdominoperineal resection rate (OR = 1.47, 95%CI [0.91 to 2.37], p = 0.11), local recurrence (OR = 0.94, 95%CI [0.44 to 2.04], p = 0.88), and distant recurrence (OR = 0.88, 95%CI [0.52 to 1.48], p = 0.62). sTME was associated with significantly longer operative time (MD = 25.62 min, 95%CI[11.92 to 39.32], p < 0.001) lower number of harvested lymph nodes (MD = - 2.25 lymph node, 95%CI [- 3.86 to - 0.65], p = 0.006), and higher proportion of incomplete TME (OR = 0.25, 95%CI [0.11 to 0.61], p = 0.002). CONCLUSIONS: sTME is not associated with increased postoperative morbidity, mortality, or local recurrence. However, the operative times are longer and yield a poor specimen quality.

Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study.

BACKGROUND: Radical surgery via total mesorectal excision might not be the optimal first-line treatment for early-stage rectal cancer. An organ-preserving strategy with selective total mesorectal excision could reduce the adverse effects of treatment without substantially compromising oncological outcomes. We investigated the feasibility of recruiting patients to a randomised trial comparing an organ-preserving strategy with total mesorectal excision. METHODS: TREC was a randomised, open-label feasibility study done at 21 tertiary referral centres in the UK. Eligible participants were aged 18 years or older with rectal adenocarcinoma, staged T2 or lower, with a maximum diameter of 30 mm or less; patients with lymph node involvement or metastases were excluded. Patients were randomly allocated (1:1) by use of a computer-based randomisation service to undergo organ preservation with short-course radiotherapy followed by transanal endoscopic microsurgery after 8-10 weeks, or total mesorectal excision. Where the transanal endoscopic microsurgery specimen showed histopathological features associated with an increased risk of local recurrence, patients were considered for planned early conversion to total mesorectal excision. A non-randomised prospective registry captured patients for whom randomisation was considered inappropriate, because of a strong clinical indication for one treatment group. The primary endpoint was cumulative randomisation at 12, 18, and 24 months. Secondary outcomes evaluated safety, efficacy, and health-related quality of life assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30 and CR29 in the intention-to-treat population. This trial is registered with the ISRCTN Registry, ISRCTN14422743. FINDINGS: Between Feb 22, 2012, and Dec 19, 2014, 55 patients were randomly assigned at 15 sites; 27 to organ preservation and 28 to radical surgery. Cumulatively, 18 patients had been randomly assigned at 12 months, 31 at 18 months, and 39 at 24 months. No patients died within 30 days of initial treatment, but one patient randomly assigned to organ preservation died within 6 months following conversion to total mesorectal excision with anastomotic leakage. Eight (30%) of 27 patients randomly assigned to organ preservation were converted to total mesorectal excision. Serious adverse events were reported in four (15%) of 27 patients randomly assigned to organ preservation versus 11 (39%) of 28 randomly assigned to total mesorectal excision (p=0·04, χ2 test). Serious adverse events associated with organ preservation were most commonly due to rectal bleeding or pain following transanal endoscopic microsurgery (reported in three cases). Radical total mesorectal excision was associated with medical and surgical complications including anastomotic leakage (two patients), kidney injury (two patients), cardiac arrest (one patient), and pneumonia (two patients). Histopathological features that would be considered to be associated with increased risk of tumour recurrence if observed after transanal endoscopic microsurgery alone were present in 16 (59%) of 27 patients randomly assigned to organ preservation, versus 24 (86%) of 28 randomly assigned to total mesorectal excision (p=0·03, χ2 test). Eight (30%) of 27 patients assigned to organ preservation achieved a complete response to radiotherapy. Patients who were randomly assigned to organ preservation showed improvements in patient-reported bowel toxicities and quality of life and function scores in multiple items compared to those who were randomly assigned to total mesorectal excision, which were sustained over 36 months' follow-up. The non-randomised registry comprised 61 patients who underwent organ preservation and seven who underwent radical surgery. Non-randomised patients who underwent organ preservation were older than randomised patients and more likely to have life-limiting comorbidities. Serious adverse events occurred in ten (16%) of 61 non-randomised patients who underwent organ preservation versus one (14%) of seven who underwent total mesorectal excision. 24 (39%) of 61 non-randomised patients who underwent organ preservation had high-risk histopathological features, while 25 (41%) of 61 achieved a complete response. Overall, organ preservation was achieved in 19 (70%) of 27 randomised patients and 56 (92%) of 61 non-randomised patients. INTERPRETATION: Short-course radiotherapy followed by transanal endoscopic microsurgery achieves high levels of organ preservation, with relatively low morbidity and indications of improved quality of life. These data support the use of organ preservation for patients considered unsuitable for primary total mesorectal excision due to the short-term risks associated with this surgery, and support further evaluation of short-course radiotherapy to achieve organ preservation in patients considered fit for total mesorectal excision. Larger randomised studies, such as the ongoing STAR-TREC study, are needed to more precisely determine oncological outcomes following different organ preservation treatment schedules. FUNDING: Cancer Research UK.

Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Roux-en-Y Gastric Bypass in Elderly Bariatric Patients: Safety and Efficacy-a Systematic Review and Meta-analysis.

INTRODUCTION: Obesity is a chronic disease due to excess fat storage, a genetic predisposition, and environmental contribution where surgery offers a viable treatment option. The surgical treatment of obesity in the elderly population (> 55 years) remains controversial. PURPOSE: To evaluate the safety and efficacy of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in elderly bariatric patients. MATERIALS AND METHODS: Data was sourced from MEDLINE, EMBASE, CINAHL, PubMed, and Cochrane databases for peer-reviewed, randomized controlled trials, and observational studies in the English language were searched from the year 1991 until 2019. From the extracted data, early and late procedural complications and mortality were used as safety outcomes. Weight loss was the primary outcome for effectiveness while the resolution of obesity-related comorbidities was included as secondary outcomes. The Review Manager (Rev Man 5.3)™ software was used for statistical analysis. RESULTS: Of the forty-one screened studies, nine studies were included in the final analysis. There was no difference between LSG and LRYGB regarding early complications and mortality 3.6% versus 5.8% (p = 0.15) and 0.1% versus 0.8% (p = 0.27). Patients who underwent LRYGB had more late complications compared with those who underwent LSG (0.07% and 0.03%, p = 0.001). There was no difference in terms of weight loss at the end of 1 year. Patients who underwent LRYGB had a better resolution of obesity-related comorbidities, not statistically significant. CONCLUSION: LRYGB has better efficacy when compared with LSG. However, high-risk elderly patients should be considered for LSG given the lesser morbidity and comparable efficacy with LRYGB.

'Mesh hiatal hernioplasty' versus 'suture cruroplasty' in laparoscopic para-oesophageal hernia surgery; a systematic review and meta-analysis.

In laparoscopic 'paraoesophageal hernia' (POH) repair, non-absorbable suture materials have been used to close the crural defects. More recently, various types of prosthetic mesh have been utilized to repair the defect. We conducted a systematic review with meta-analysis of the recent and up to-date studies incorporating 942 POH repairs. We examined the rates of recurrence, reoperation, and complication rates alongside operative time of these two techniques in the management POH. Randomized controlled trials (RCT) and observational studies comparing mesh hiatal hernioplasty versus Suture cruroplasty for Paraoesophageal hernia were selected by searching Medline, Embase, and Cochrane Central database published between January 1995 and December 2016. Predefined inclusion and exclusion criteria were applied to select the studies. The outcome variables analysed are recurrence of hiatal hernia, reoperation, operative time and complications. Nine studies (RCTs = 4 and Observational studies = 5) were analysed totalling 942 patients (Mesh = 517, Suture cruroplasty = 425). The pooled effect size for recurrence favoured mesh repair over suture cruroplasty (OR 0.48, 95% CI 0.32, 0.73, P < 0.05). But the operation time is significantly less in suture cruroplasty (SMD 15.40, 95% CI 7.92, 22.88, P < 0.0001). Comparable effect sizes were noted for both groups which included reoperation (OR 0.35, 95%CI 0.09, 1.31, P = 0.12) and complication rates (OR 1.30, 95%CI 0.74, 2.29, P = 0.36). Our systematic review and meta-analysis demonstrates that mesh hiatoplasty and suture cruroplasty produce comparable results with regards to reoperation rate and complications following the repair of paraoesophageal hernias (POH). Moreover, the study showed significant reduction of recurrence following mesh hiatoplasty.

The NHS Bowel cancer screening programme achieves the anticipated survival improvement, but participation must be improved.

Purpose The NHS Bowel cancer screening programme (NHSBCSP) aims to reduce colorectal cancer (CRC) cumulative mortality by up to 23 per cent; long-term outcomes at national level are not yet known. The purpose of this paper is to examine a local population of CRC patients of screening age for their characteristics and long-term survival in relation to their presentation, including through the NHSBCSP. Design/methodology/approach Retrospective analysis of a prospectively maintained CRC database for the years 2009-2014 in a single district hospital providing bowel cancer screening and tertiary rectal cancer services. Findings Of 528 CRC patients diagnosed in the screening age range, 144(27.3 per cent) presented through NHSBCSP, 308(58.3 per cent) electively with symptoms and 76(14.4 per cent) as emergency. NHSBCSP-diagnosed patients were younger (median 66 vs 68 and 69 years, respectively, p=0.001), had more often left-sided cancers (59(41.0 per cent) vs 82(26.6 per cent) and 24(31.6 per cent), respectively, p=0.001), more UICC-stage I (42(29.2 per cent) vs 49(15.9 per cent) and 2(2.6 per cent)), stage III (59(41.0 per cent) vs 106(34.4 per cent) and 20(26.3 per cent)) and less stage IV disease (8(5.6 per cent) vs 61(19.8 per cent) and 34 (44.7 per cent), respectively, p<0.001). Three-year overall survival was best for NHSBCSP and worst for emergency patients (87.5 per cent vs 69.0 per cent and 35.3 per cent, respectively, LogRank p<0.001). Originality/value Patients diagnosed within the NHSBCSP have improved outcome compared to both symptomatic elective and emergency presentations. A reduction in overall cumulative mortality in order of 25 per cent may well be achieved, but continuing high levels of emergency presentations and undetected right-sided disease emphasise need for further improvement in public participation in the NHSBCSP and research into more sensitive and acceptable alternative screening methods.

Volume-outcome relationship for colorectal cancer in primary care: a prospective cohort study.

Purpose Higher caseloads are associated with better outcomes for many conditions treated in secondary and tertiary care settings, including colorectal cancer (CRC). There is little known whether such volume-outcome relationship exist in primary care settings. The purpose of this paper is to examine general practitioner (GP) CRC-specific caseload for possible associations with referral pathways, disease stage and CRC patients' overall survival. Design/methodology/approach The paper retrospectively analyses a prospectively maintained CRC database for 2009-2014 in a single district hospital providing bowel cancer screening and tertiary rectal cancer services. Findings Of 1,145 CRC patients, 937 (81.8 per cent) were diagnosed as symptomatic cancers. In total, 210 GPs from 44 practices were stratified according to their CRC caseload over the study period into low volume (LV, 1-4); medium volume (MV, 5-7); and high volume (HV, 8-21 cases). Emergency presentation (LV: 49/287 (17.1 per cent); MV: 75/264 (28.4 per cent); HV: 105/386 (27.2 per cent); p=0.007) and advanced disease at presentation (LV: 84/287 (29.3 per cent); MV: 94/264 (35.6 per cent); HV: 144/386 (37.3 per cent); p=0.034) was more common amongst HV GPs. Three-year mortality risk was significantly higher for HV GPs (MV: (hazard ratio) HR 1.185 (confidence interval=0.897-1.566), p=0.231, and HV: HR 1.366 (CI=1.061-1.759), p=0.016), but adjustment for emergency presentation and advanced disease largely accounted for this difference. There was some evidence that HV GPs used elective cancer pathways less frequently (LV: 166/287 (57.8 per cent); MV: 130/264 (49.2 per cent); HV: 182/386 (47.2 per cent); p=0.007) and more selectively (CRC/referrals: LV: 166/2,743 (6.1 per cent); MV: 130/2,321 (5.6 per cent); HV: 182/2,508 (7.3 per cent); p=0.048). Originality/value Higher GP CRC caseload in primary care may be associated with advanced disease and poorer survival; more work is required to determine the reasons and to develop targeted intervention at local level to improve elective referral rates.

Single-incision laparoscopic (SIL) sigmoid colectomy and uterus-preserving repair for colo-uterine fistula secondary to severe diverticular disease: an unusual technical solution for an unusual presentation of a common disease.

Colouterine fistula as a potential complication of chronic diverticulitis is a rare entity with less than 30 cases reported worldwide. Generally, patients require a multidisciplinary approach including a major laparotomy with hysterectomy and sigmoid colectomy, and, occasionally, temporary colostomy. We report the first attempt of a novel, minimally invasive technique for managing a case of benign colouterine fistula with single-incision laparoscopic (SIL) sigmoid colectomy and uterus preservation. A small, 3 cm incision site provided access for the whole operation, as well as played a role as the specimen extraction site. Malignant fistulas and large uterine defects may require hysterectomy, however, laparoscopic closure of uterine wall defects can be considered as a reasonable alternative in selected patients, avoiding the higher risks associated with hysterectomy and keeping fertility at younger ages. Single incision laparoscopy in complicated diverticular disease and fistula formation cases is a challenging but technically feasible option, in experienced hands.

Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique.

BACKGROUND: The treatment of complex fistulae-in-ano is challenging and often includes a number of operations due to high rates of recurrence. Recently, techniques using in vitro expanded adipose tissue-derived stem cells have been described. We describe a novel treatment for cryptoglandular fistulae used in 7 patients, using a combination of surgical closure of the internal opening and real-time autologous adipose tissue-derived regenerative cells (ADRC)-enhanced lipofilling, without need for in vitro expansion. METHODS: Following exclusion of active perianal sepsis, patients underwent a standard tumescent liposuction procedure, harvesting ~300 to 400 mL of raw lipoaspirate. The lipoaspirate was prepared in real time, using the Celution 800/CRS system to obtain the stromal vascular fraction containing ADRCs. After excision of the fistula tract and closure of the internal orifice, fresh ADRC-enhanced lipoaspirate was injected into and around the fistula tract. RESULTS: At 6-months' follow-up, 5 of 7 (71.4%) patients showed clinical signs of fistula closure; one of these patients had a recurrence at 10 months due to sepsis. The remaining 4 patients (57.1%) all had complete fistula closure at a median of 46 months' follow-up. There were no adverse events associated with the technique, and no new incontinence. CONCLUSION: Treatment of cryptoglandular fistulae-in-ano with ADRC-enhanced lipofilling appears feasible and safe, and may add to the range of procedures that can be used to treat this difficult problem.

Transanal Endoscopic Microsurgery (TEM) for Rectal Cancer: University Hospital of North Tees Experience.

Transanal endoscopic microsurgery (TEM) is a minimally invasive technique that is increasingly being used to treat early rectal cancer (T1/T2). We studied the outcomes of TEM for rectal cancer at our institution looking at the indication, recurrence rate, need for further radical surgery, 30-day and 12-month mortality and complication rate. We performed a retrospective analysis of prospectively collected data of cases between 2008 and 2012: 110 TEM procedures were performed during this period: 40 were confirmed rectal cancers and 70 were benign. We analysed the data for the 40 patients with confirmed rectal cancer. Thirty (75 %) of the subjects were male with a mean age of 71 ± 10 years (range 49-90 years) and 19 (48 %) patients were ASA 3 and 4. Nineteen (48 %) of cancers were pT1, eighteen (45 %) were pT2, two (5 %) were pT3 and one was yPT0. Mean specimen size was 66 ± 20 mm (range 33-120 mm) with a mean polyp size of 41 ± 24 mm (range 18-110 mm). The mean cancer size was 24 ± 13 mm (range 2-50 mm). Average distance from the anal verge was 70 ± 37 mm (range 10-150 mm), and the mean operating time was 72 ± 22 min (range 40-120 min), with an average blood loss of 28 ± 15 ml (range 10-50ml). Median hospital stay was 2 ± 1 days (range 1-7 days). Complete excision (R0) was achieved in 37 (93 %) patients. Minor post-operative complications included urinary retention in two and pyrexia in three patients. There were no 30-day or 12-month mortalities. Mean follow-up was 13 ± 11 months, range (3-40 months) Local recurrence occurred in two (5 %) patients, both underwent redo TEM. Twelve (30 %) patients underwent laparoscopic radical resections (seven AR and five APER) post-TEM. Post-operative histology confirmed pT0N0 in 7/12 patients. Three were lymph node-positive (T0N1), one was pT3N1 and the fifth was pT3N2. TEM is associated with quicker recovery, shorter hospital stay and fewer complications than radical surgery. It is a good alternative to radical surgery in early rectal cancer, especially for high-risk patients. Recurrent tumours can be treated with redo TEM.

Autologous adipose-tissue derived regenerative cells for the treatment of complex cryptoglandular fistula-in-ano: a report of three cases.

The treatment of complex fistulae-in-ano is challenging and often includes a number of operations due to high rates of recurrence. We report the successful treatment of three consecutive patients with long-standing cryptoglandular fistula-in-ano with a novel combination of mucosal advancement flap and adipose-tissue derived regenerative cells (ADRCs) from the stromal vascular fraction (SVF) obtained from a simple lipoaspiration procedure, using Celution technology. There was no operative morbidity; one patient who had a colostomy for faecal diversion has since undergone restoration of bowel continuity. All thee fistulae remain healed at 2-3-year follow-up. Lipofilling of cryptoglandular fistulae-in-ano with ADRC-enhanced lipofilling appears feasible and safe, and may add to the range of procedures that can be used to treat this difficult problem.