Endoscopic Submucosal Dissection (ESD) Offers a Safer and More Cost-effective Alternative to Transanal Endoscopic Microsurgery (TEM): An International Collaborative Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) are minimally invasive procedures that treat early rectal cancer (ERC). Both are effective treatments, yet there are very few studies comparing them. The aim of our study was to identify ideal candidates for each procedure. MATERIALS AND METHODS: Between January 2016 and November 2019, 204 ERC patients were managed with either ESD (n=101) or TEM (n=103) at 7 international centers. Data analyzed included clinical success, tumor characteristics, procedure info, and recurrence rates. RESULTS: Median tumor size was 40 mm±23.9 in the ESD group and 56 mm±27.9 in the TEM group, significantly larger in the latter ( P <0.00001). Average procedure time was 131.5±67.9 minutes in ESD group and 104.9±28.4 minutes in TEM group ( P =0.000347). Average hospital stay was 3.3±2.6 days in the ESD group and 4.7±0.7 days in the TEM group ( P <0.00001). Adverse event rate was 6.8% in the ESD group and 24% in the TEM group. There were no significant difference in the rate of en bloc resection, technical success, tumor location, necessity of additional procedures, and tumor recurrence rates. CONCLUSION: Compared with TEM, ESD is a safer procedure with shorter hospital stay and should be offered for patients who have ERC.

Transanal endoscopic microsurgery versus radical resection for early-stage rectal cancer: a systematic review and meta- analysis.

PURPOSE: In the treatment of early-stage rectal cancer, a growing number of studies have shown that transanal endoscopic microsurgery is one of the alternatives to radical surgery adhering to total mesorectal excision that can reduce the incidence of adverse events without compromising treatment outcomes. The purpose of this meta-analysis is to compare the safety and treatment effect of transanal endoscopic microsurgery and radical surgery adhering to total mesorectal excision to provide a basis for clinical treatment selections. METHOD: We searched the literatures of four major databases, PubMed, Embase, Web of science, and Cochrane Library, without limitation of time. The literatures included randomized controlled studies and cohort studies comparing two surgical procedures of transanal endoscopic microsurgery and radical surgery adhering to total mesorectal excision. Treatment effectiveness and safety results of transanal endoscopic microsurgery and radical surgery were extracted from the included literatures and statistically analyzed using RevMan5.4 and stata17. RESULT: Ultimately, 13 papers were included in the study including 5 randomized controlled studies and 8 cohort studies. The results of the meta-analysis showed that the treatment effect and safety of both transanal endoscopic microsurgery and radical surgery in distant metastasis (RR, 0.59 (0.34, 1.02), P > 0.05), overall recurrence (RR, 1.49 (0.96, 2.31), P > 0.05), disease-specific-survival (RR, 0.74 (0.09, 1.57), P > 0.05), dehiscence of the sutureline or anastomosis leakage (RR, 0.57 (0.30, 1.06), P > 0.05), postoperative bleeding (RR, 0.47 (0.22, 0.99), P > 0.05), and pneumonia (RR, 0.37, (0.10, 1.40), P > 0.05) were not significantly different. However, they differ significantly in perioperative mortality (RR, 0.26 (0.07, 0.93, P < 0.05)), local recurrence (RR, 2.51 (1.53, 4.21), P < 0.05),_overall survival_ (RR, 0.88 (0.74, 1.00), P < 0.05), disease-free-survival (RR, 1.08 (0.97, 1.19), P < 0.05), temporary stoma (RR, 0.05 (0.01, 0.20), P < 0.05), permanent stoma (RR, 0.16 (0.08, 0.33), P < 0.05), postoperative complications (RR, 0.35 (0.21, 0.59), P < 0.05), rectal pain (RR, 1.47 (1.11, 1.95), P < 0.05), operation time (RR, -97.14 (-115.81, -78.47), P < 0.05), blood loss (RR, -315.52 (-472.47, -158.57), P < 0.05), and time of hospitalization (RR, -8.82 (-10.38, -7.26), P < 0.05). CONCLUSION: Transanal endoscopic microsurgery seems to be one of the alternatives to radical surgery for early-stage rectal cancer, but more high-quality clinical studies are needed to provide a reliable basis.

Risk factors and treatment of rectal stenosis after transanal endoscopic microsurgery.

AIM: Rectal stenosis is a relatively rare complication after transanal endoscopic microsurgery (TEM). This study aims to identify the predictive parameters for stenosis and the application of TEM in the treatment. METHOD: The clinical data of patients who underwent TEM for rectal adenoma and early cancer from 2008 to 2019 were retrospectively reviewed. We compared the clinicopathological characteristics of patients with stenosis and those without stenosis and analysed the risk factors for stenosis. Treatment outcomes of stenosis with TEM were evaluated. RESULTS: A total of 230 patients were enrolled in this study. Overall, the postoperative complication rate was 11.7% (27/230), including eight (3.5%) patients with stenosis. Patients with stenosis exhibited a higher rate of tumour showing a laterally spreading morphology (P = 0.048), a wider circumferential extent of mucosal defect (P < 0.001), a shorter distance of the tumour from the anal verge (P = 0.001) and a wider longitudinal extent of mucosal defect (P = 0.027). A circumferential extent of mucosal defect >3/4 (OR 94.945, 95% CI 3.611-2496.41, P = 0.006) was identified as the only independent risk factor for stenosis. The four patients with both stenosis and clinical symptoms were treated by incising the stenosis ring using the TEM platform; the stenosis was cured, and symptoms disappeared after one to four courses of treatment. CONCLUSIONS: Circumferential extent of mucosal defect ≥3/4 was an independent risk factor for stenosis in treating rectal adenoma and early cancer with TEM. Incision of the stenosis ring using the TEM platform is an effective strategy for treating stenosis.

Long-term outcomes of transanal endoscopic microsurgery for clinical complete response after neoadjuvant treatment in T2-3 rectal cancer.

BACKGROUND: Organ sparing by the transanal endoscopic microsurgery (TEM) procedure is a treatment for patients with locally advanced rectal cancer after chemoradiotherapy (CRT) and complete clinical response (cCR). AIMS: To assess the surgical and long-term oncological outcomes of TEM for the treatment in T2-3 rectal cancer after CRT and cCR. METHODS: This study was a retrospective review of a prospective database of patients with rectal cancer who underwent TEM after CRT and cCR from April 2011 to March 2020. RESULTS: 52 patients underwent TEM during a period of 9 years. This group of patients included 27 females and 25 males. The median age was 62 (32-86) years, lesion size was 2.5 (1-4) cm, and lesion distance from the anal verge 7.3 (4-10) cm. Median operative time was 79.5 (25-120) min and hospital stay was 1 day (14 h-4 days). Morbidity rate was 13.5% and reoperation rate due to major complications was 3.8%. Final histological findings confirmed 34 (65.4%) patients with ypT0, 7 (13.5%), 6 (11.5%), and 5 (9.6%) patients with carcinoma ypT1, ypT2, and ypT3, respectively. After a median follow-up period of 86 (5-107) months, 1 (2.4%) patient had local recurrences and 3 (7.3%) distant metastases. The 5-year disease-free survival was 91.7% and 5-year overall survival 89.5%. CONCLUSION: Our experience has shown significant rates of ypT0 and ypT1 associated with excellent long-term results. Performing TEM to treat T2-3N0 rectal cancer after CRT and cCR appears to be an oncologically safe and effective procedure.

Completion total mesorectal excision following transanal endoscopic microsurgery does not compromise outcomes in patients with rectal cancer.

BACKGROUND: Transanal endoscopic microsurgery (TEM) represents a choice of treatment in patients with neoplastic lesions in the rectum. When TEM fails, completion total mesorectal excision (cTME) is often required. However, a concern is whether cTME increases the rate of abdominoperineal resections (APR) and is associated with higher risk of incomplete mesorectal fascia (MRF) resection. The aim of this study was to compare outcomes of cTME with primary TME (pTME) in patients with rectal cancer. METHODS: This was a nationwide study on all patients with cTME from the Danish Colorectal Cancer Group database between 2005 and 2015. Patients with cTME were compared to patients with pTME after propensity score matching (matching ratio 1:2). Matching variables were age, gender, tumor distance from anal verge, American Society of Anesthesiologists (ASA) score and American Joint Committee on Cancer (AJCC) stage. RESULTS: A total of 60 patients with cTME were compared with 120 patients with pTME. Patients with cTME experienced more intraoperative complications as compared to pTME patients (18.3% vs. 6.7%, p = 0.021). However, there was no difference in the rate of perforations at or near the tumor/previous TEM site (6.7% vs. 2.5%, p = 0.224), conversion to open surgery (p = 0.733) or 30-day morbidity (p = 0.86). On multivariate analysis, cTME was not a risk factor for APR (OR 2.49; 95% CI 0.95-6.56; p = 0.064) or incomplete MRF (OR 1.32; 95% CI 0.48-3.63; p = 0.596). There was no difference in the rate of local recurrence between cTME and pTME (5.2% vs. 4.3%, p = 0.1), distant metastases (6.8% vs. 6.8%, p = 1), or survival (p = 0.081). The mean follow-up time was 6 years. CONCLUSION: In our study, the largest so far on the subject, we find no difference in postoperative short- or long-term outcomes between cTME and pTME.

Short-term clinical and functional results of rectal wall suture defect after transanal endoscopic microsurgery-a prospective cohort study.

PURPOSE: Our goal was to assess the outcomes of rectal wall suture during the early and late periods after transanal endoscopic microsurgery (TEM) and long-term bowel function. METHODS: Patients who underwent TEM for rectal neoplasms from May 2017 to March 2021 were prospectively included. A total of 70 patients were enrolled. Seven to 10 days after TEM, clinical data were recorded, and digital rectal examination and rigid proctoscopy were performed. After at least 6 months, bowel function was evaluated using low anterior resection syndrome (LARS) and Wexner questionnaires. RESULTS: Forty-five men with an average age of 67 ± 10.1 (40-85) were included. TEM sutures were recorded as intact in 48/70 (68%) and as dehiscent in 22/70 (32%). It did not have any significant clinical manifestation and was not related with longer postoperative stay or incidence of postoperative complications. Eight of 22 (36.4%) patients with suture dehiscence had per rectal bleeding or febrile temperature without any need for intervention or treatment. The only risk factor for wound dehiscence was a posteriorly located defect. In late postoperative period, there was no difference between groups in LARS or Wexner questionnaire (p value 0.72 and 0.85, respectively). CONCLUSIONS: Our study suggests that 1/3 of the patients' rectal wall defect after TEM will undergo dehiscence in early postoperative period and will not transfer to clinically significant manifestation (without a need of hospitalization or prolonging it). In late postoperative period, there is no difference in bowel function.

Inflammatory cloacogenic polyp in an adolescent - case report and review of the literature.

Inflammatory cloacogenic polyp is a rare lesion arising in the anal transitional zone. It is usually benign, but rare cases of malignant transformation are known. It is most commonly seen in the adult population from the fourth to the sixth decade of life, but it can be found among children and adolescents as well. The most common clinical symptoms include rectal bleeding and altered bowel habits, although some patients may be asymptomatic. Treatment involves transanal endoscopic microsurgery followed by a bowel regimen with stool softeners. We present the case report of a 14-year-old boy presenting with intermittent rectal bleeding in whom a polypoid lesion was found during digital rectal examination. The patient underwent proctosigmoidoscopy during which the suspicious lesion was removed by transanal endoscopic microsurgery and the histological diagnosis of inflammatory cloacogenic polyp was established. In the postoperative period, the patient was without any further problems. In this case report, we want to raise awareness of this rare diagnosis and emphasize its place in the differential diagnosis of rectal bleeding across all age groups.

[Results of total mesorectal excision and transanal endoscopic microsurgery for rectal adenocarcinoma with submucosal invasion]. / Rezul'taty total'noi mezorektumektomii i transanal'noi endomikrokhirurgii pri adenokartsinomakh pryamoi kishki s invaziei v podslizistyi sloi.

OBJECTIVE: To analyze early and long-term outcomes after total mesorectal excision (TME) and transanal endoscopic microsurgery (TEM) in patients with T1 rectal cancer. MATERIAL AND METHODS: A retrospective non-randomized comparative study included 2 groups of patients: group 1 - total mesorectal excision, group 2 - transanal endoscopic microsurgery. In the second group, total mesorectal excision was proposed for patients with tumor invasion depth pT1sm3 and/or lymphovascular invasion and/or low differentiation. If total mesorectal excision was performed as a salvage surgery, the patient was excluded from further analysis. RESULTS: There were 156 patients with rectal adenocarcinoma pT1 between October 2011 and August 2019 (102 cases - TEM, 54 cases - TME). We excluded 10 patients from the TEM group due to salvage surgery. Duration of TEM was 40.0 (34; 50) min, TME - 139 (120; 180) min (p=0.00001). Postoperative hospital-stay was also significantly less in the TEM group (7 (6; 9) vs. 10 (7; 11) days, p=0.00001). Six (6.5%) patients in the TEM group and 1 (1.8%) patient in the TME group developed a local recurrence in pelvic cavity (p=0.1). There were no distant metastases. Disease-free 3-year survival was 92% after TEM and 96% after TME (p=0.058). CONCLUSION: Transanal endoscopic microsurgery is a relatively safe alternative to total mesorectal excision for early rectal cancer.

Long-term outcomes of open versus closed rectal defect after transanal endoscopic microscopic surgery.

AIM: Management of the rectal defect after transanal endoscopic microsurgery (TEM) is a matter of debate. Data are lacking on long term outcomes and continence of patients with open or closed rectal defect. We sought to analyse these in a retrospective cohort study. METHODS: Patients undergoing TEM via the Specialist Early Rectal Cancer (SERC) MDT between 2012 and 2019 were included from a prospectively maintained database. These were divided into two groups - open and closed, based on management of rectal defect. Patient demographics and outcomes, including pre- and postoperative oncological staging, morbidity, mortality, length of stay and faecal incontinence severity score (FISI) scores were assessed. RESULTS: A total of 170 matched patients were included (70-open, 100-closed rectal defects). Short-term complications (bleeding, infection, urinary retention and infection, length of stay and pain) were 18.8% with no significant difference between the two groups (22% vs. 16%). Most of the defects were well healed upon endoscopic follow-up; more unhealed/sinus formation was noticed in the open group (p = 0.01); more strictures were encountered in the closed group (p = 0.04). Comparing the open and closed defect groups, there was no difference in the functional outcome of patients in those who developed sinus (p = 0.87) or stricture (p = 0.79) but a significant difference in post-TEMS FISI scores in those with healed scar, with those in closed rectal defect group with worsening function (p = 0.02). CONCLUSION: There are pros and cons associated with both rectal defect management approaches. Long-term complications should be expected and actively followed up. Patients should be thoroughly counselled about these and possible deterioration in continence post-TEM.

Feasibility and Safety of Endoscopic Submucosal Dissection for Recurrent Rectal Lesions that after Transanal Endoscopic Microsurgery: A Case Series.

OBJECTIVES: Recently, several studies have demonstrated the usefulness of endoscopic submucosal dissection (ESD) for residual or locally recurrent colorectal lesions after endoscopic treatment. However, the feasibility of ESD for recurrent rectal lesions after transanal endoscopic microsurgery (TEM) has not been fully investigated. In this study, we evaluated the feasibility and safety of ESD for recurrent rectal lesions after TEM. METHODS: The treatment outcomes of 10 lesions in 9 patients, who underwent ESD between January 2006 and March 2018 for recurrent rectal lesions after transanal endoscopic microsurgery, were evaluated. RESULTS: All lesions were successfully resected en bloc, and the R0 resection rate was 90%. The median size of the resected specimens and lesions (range) was 44 mm (21-70) and 27.5 mm (5-60), respectively. The pathological diagnoses included 4 adenomas and 6 cancerous lesions. The cancerous lesions included 5 cases of mucosal cancer and 1 case of superficial submucosal invasive cancer (depth of submucosal invasion <1,000 µm from the muscularis mucosae). No adverse events occurred. There was no recurrence during the follow-up period. CONCLUSIONS: ESD for recurrent rectal lesions after TEM by expert's hands appears to be safe and feasible.

Preoperative chemoradiotherapy affects postoperative outcomes and functional results in patients treated with transanal endoscopic microsurgery for rectal neoplasms.

BACKGROUND: The aim of this study was to quantify the incidence of short-term postoperative complications and functional disorders at 1 year from transanal endoscopic microsurgery (TEM) for rectal neoplasms, to compare patients treated with TEM alone and with TEM after preoperative chemoradiotherapy (CRT) and to analyse factors influencing postoperative morbidity and functional outcomes. METHODS: A retrospective study was conducted on all patients treated with TEM for rectal neoplasms at our institution in January 2000-December 2017. Data from a prospectively maintained database were retrospectively analysed. Patients were divided into two groups: adenoma or early rectal cancer (no CRT group) and locally advanced extraperitoneal rectal cancer with major or complete clinical response after preoperative CRT (CRT group). Short-term postoperative mortality and morbidity and the functional results at 1 year were recorded. The two groups were compared, and a statistical analysis of factors influencing postoperative morbidity and functional outcomes was performed. Functional outcome was also evaluated with the low anterior resection syndrome (LARS) score (0-20 no LARS, 21-29 minor LARS and 30-42 major LARS). RESULTS: One hundred and thirteen patients (71 males, 42 females, median age 64 years [range 41-80 years]) were included in the study (46 in the CRT group). The overall postoperative complication rate was 23.0%, lower in the noCRT group (p < 0.001), but only 2.7% were grade ≥ 3. The most frequent complication was suture dehiscence (17.6%), which occurred less frequently in the noCRT group (p < 0.001). At 1 year from TEM, the most frequent symptoms was urgency (11.9%, without significant differences between the CRT group and the noCRT group); the noCRT group experienced a lower rate of soiling than the CRT group (0% vs. 7.7%; p: 0.027). The incidence of LARS was evaluated in 47 patients from May 2012 on and was 21.3% occurring less frequently in the noCRT group (10% vs. 41.2%; p: 0.012). Only 6.4% of the patients evaluated experienced major LARS. In multivariate analysis, preoperative CRT significantly worsened postoperative morbidity and functional outcomes. CONCLUSIONS: TEM is a safe procedure associated with only low risk of severe postoperative complications and major LARS. Preoperative CRT seems to increase the rate of postoperative morbidity after TEM and led to worse functional outcomes at 1 year after surgery.

Endoscopic submucosal dissection (ESD) versus transanal endoscopic microsurgery (TEM) for treatment of rectal tumors: a comparative systematic review and meta-analysis.

BACKGROUND: While multiple studies have evaluated endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) to remove large rectal tumors, there remains a paucity of data to evaluate their comparative efficacy and safety. The primary aim of this study was to perform a structured systematic review and meta-analysis to compare efficacy and safety of ESD versus TEM for the treatment of rectal tumors. METHODS: Individualized search strategies were developed from inception through November 2018 in accordance with PRISMA guidelines. Measured outcomes included pooled enbloc resection rates, margin-negative (R0) resection rates, procedure-associated adverse events, and rates of recurrence. This was a cumulative meta-analysis performed by calculating pooled proportions. Heterogeneity was assessed with Cochran Q test and I2 statistics, and publication bias by funnel plot using Egger and Begg tests. RESULTS: Three studies (n = 158 patients; 55.22% male) were included in this meta-analysis. Patients with ESD compared to TEM had similar age (P = 0.090), rectal tumor size (P = 0.108), and diagnosis rate of adenoma to cancer (P = 0.53). ESD lesions were more proximal as compared to TEM (8.41 ± 3.49 vs. 5.11 ± 1.43 cm from the anal verge; P < 0.001). Procedure time and hospital stay were shorter for ESD compared to TEM [(79.78 ± 24.45 vs. 116.61 ± 19.35 min; P < 0.001) and (3.99 ± 0.32 vs. 5.83 ± 0.94 days; P < 0.001), respectively]. No significant differences between enbloc resection rates [OR 0.98 (95% CI 0.22-4.33); P = 0.98; I2 = 0.00%] and R0 resection rates [OR 1.16 (95% CI 0.36-3.76); P = 0.80; I2 = 0.00%] were noted between ESD and TEM. ESD and TEM reported similar rates of adverse events [OR 1.15 (95% CI 0.47-2.77); P = 0.80; I2 = 0.00%] and rates of recurrence [OR 0.46 (95% CI 0.07-3.14); P = 0.43; I2 = 0.00%]. CONCLUSION: ESD and TEM possess similar rates of resection, adverse events, and recurrence for patients with large rectal tumors; however, ESD is associated with significantly shorter procedure times and duration of hospitalization. Future studies are needed to evaluate healthcare utilization for these two strategies.

Quality of Life and Bowel Dysfunction after Transanal Endoscopic Microsurgery for Rectal Cancer: One Third of Patients Experience Major Low Anterior Resection Syndrome.

BACKGROUND/AIMS: The low anterior resection syndrome (LARS) severely affects quality of life (QoL) after rectal cancer surgery. Studies investigating LARS and the effect on QoL after transanal endoscopic microsurgery (TEM) for rectal cancer are scarce. The aim of our study was to assess bowel dysfunction and QoL after TEM. METHODS: Seventy-three -patients who underwent TEM for stage I rectal cancer were included in this single-centre, cross-sectional study Bowel dysfunction was assessed by the LARS-Score, QoL by the -European Organization for the Research and Treatment of Cancer QLQ-C30 and -CR29 questionnaires. RESULTS: Fifty-five respondents (75.3%) could be included for the analyses. The median interval since treatment was 4.3 years, and the median age at the follow-up point was 72 years. "Major LARS" was observed in 29% of patients and "minor LARS" in 26%. Female gender (OR 4.00; 95% CI 1.20-13.36), neo-adjuvant chemoradiotherapy (OR 3.63; 95% CI 1.08-12.17) and specimen thickness in millimetres (OR 1.10 for each mm increase in thickness; 95% CI 1.01-1.20) were associated with the development of major LARS. Patients with major LARS fared worse in most QoL domains. CONCLUSION: This is the first study demonstrating major LARS after TEM treatment for rectal cancer, with a negative effect on QoL, even years after treatment. Our data provides an adequate counselling before TEM in terms of postoperative bowel dysfunction and its effect on QoL.

Morbidity after transanal endoscopic microsurgery: risk factors for postoperative complications and the design of a 1-day surgery program.

BACKGROUND: Transanal endoscopic microsurgery (TEM) is a minimally invasive procedure with low morbidity. The definition of risk factors for postoperative complications would help to identify the patients likely to require more care and surveillance in an ambulatory or 1-day surgery (A-OdS) program. The main endpoints are overall 30-day morbidity and relevant morbidity. The secondary objectives are to detect risk factors for complications, rehospitalization, and the time of occurrence of the postoperative complications, and to describe the adverse effects following hospitalization that the A-OdS program would avoid. METHODS: This is an observational study of consecutive patients undergoing TEM between June 2004 and December 2016. Overall and relevant morbidity based on the Clavien-Dindo (Cl-D) classification were recorded, as were demographic, preoperative, surgical, and pathology variables. Univariate and multivariate analyses of the risk factors were carried out. RESULTS: Six hundred and ninety patients underwent surgery, of whom 639 were included in the study. Overall morbidity rate was 151/639 patients (23.6%); the clinically relevant morbidity rate was 36/639 (Cl-D > II) (5.6%) and mortality 2/639 (0.3%). The most frequent complication was rectal bleeding, recorded in 16.9% (108/639 patients) and grade I in 86/108 patients (78. 9%). The period with the greatest risk of complications was the first 2 days. The rehospitalization rate after 48 h was 7%. The risk factors for complications were as follows: tumor size > 6 cm (OR 3.2, 95% CI 1.3-7.8), anti-platelet medication (OR 2.3, 95% CI 1.1-5.1), and surgeon's experience < 150 procedures (OR 2.0, 95% CI 1-4.1). CONCLUSIONS: TEM is a safe procedure. The low rates of morbidity, re-hospitalization, and postoperative complications in the first 2 days after surgery make the procedure suitable for A-OdS.

Perforation in the peritoneal cavity during transanal endoscopic microsurgery for rectal tumors: a real surgical complication with a challenging prognosis?

BACKGROUND: Perforation in the peritoneal cavity during transanal endoscopic microsurgery represents a major challenge. It is usually treated by primary suture, though some authors propose laparoscopic repair with or without ostomy. It is unclear whether perforation increases the risk of tumor dissemination. AIM: The purpose of the study is to assess the safety of primary suture of peritoneal perforation and the long-term risk of dissemination, also, to determine risk factors for perforation and to propose a predictive model for lesions with risk of perforation. METHOD: This is an observational study with prospective data collection at Parc Taulí University Hospital, Sabadell, of patients undergoing transanal surgery with perforation into the peritoneal cavity from June 2004 to September 2017. The main variable is postoperative morbidity and mortality. The long-term follow-up of local recurrence and peritoneal tumor dissemination is described, and a quantitative predictive model for peritoneal cavity perforation is proposed. RESULTS: Forty-five patients out of 686 (6.6%) presented perforation into the peritoneal cavity. Ten patients (22.2%) in the perforation group had morbidity, a rate similar to the non-perforated group. There was no peritoneal dissemination in patients with adenoma or with carcinoma treated with curative intent. In the quantitative predictive model, risk factors for perforation were proximal edge of tumor > 14 cm from anal verge (6 points), size ≥ 6 cm (2), age ≥ 85 years (4), anterior quadrant (3) , and sex (2). Total scores of ≥ 6 points predicted perforation. CONCLUSIONS: Primary suture after peritoneal cavity perforation during transanal surgery is safe and does not increase the risk of recurrence or peritoneal dissemination. Our predictive model provides guidance regarding the risk of perforation and the need to suture the defect after transanal surgery resection.

Peritoneal perforation during transanal endoscopic microsurgery is not associated with significant short-term complications.

BACKGROUND: In patients treated by transanal endoscopic microsurgery (TEM), breach of the peritoneal cavity is a feared intraoperative challenge. Our aim is to analyze predictors and short-term outcomes of patients with peritoneal perforation (TEM-P) when compared to similar patients with no peritoneal compromise (TEM-N). METHODS: At St. Paul's Hospital, demographic, surgical, pathologic, and follow-up data for all patients treated by TEM is maintained in a prospectively populated database. A retrospective review was performed and two groups were established for comparison: TEM-P and TEM-N. Statistical analysis was performed using student's t or chi-squared test, where appropriate. RESULTS: Of 619 patients treated by TEM between 2007 and 2016, 39 (6%) patients were in the TEM-P group and 580 (94%) in the TEM-N group. There were no differences between the groups in patient age, gender, histology, or tumor size. Patients who had peritoneal perforations had more proximal lesions (11 vs. 7 cm, p < 0.0001), anterior lesions (56 vs. 43%, p < 0.05), and longer operations (80 vs. 51 min, p < 0.005). While most defects were closed endoluminally, 2 patients with perforation were converted to transabdominal surgery. There was a difference in overall hospital stay with TEM-P patients staying on average 2 days in hospital with fewer patients managed as day surgery (31 vs. 73%, p < 0.0001). There were no mortalities or significant 30-day complications in the TEM-P group and only one patient required readmission. CONCLUSIONS: The St. Paul's Hospital TEM experience suggests patients with peritoneal breach during TEM can be safely managed with outcomes similar to patients without peritoneal entry. Proximal, anterior lesions are at highest risk of peritoneal perforation.

Quality of life in patients with loco-regional rectal cancer after ELRR by TEM versus VLS TME after nChRT: long-term results.

BACKGROUND: Endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) may be an alternative treatment option to Laparoscopic total mesorectal excision (LTME), in selected patients with N0 rectal cancer. Post-operative quality of life (QoL) evaluation is an important parameter of outcomes related to high percentage of functional sequelae. We reported, in a previous paper, the short and medium term results of QoL in patients who underwent ELRR or LTME. The aim is to evaluate the 3 year QoL in patients with iT2-T3 N0/+ rectal cancer who underwent ELRR by TEM or LTME after neoadjuvant radio-chemotherapy (nChRT) in a retrospective analysis of prospectively collected data. METHODS: We enrolled in this study, 39 patients with iT2-T3 rectal cancer who underwent ELRR (n = 19) or LTME (n = 20), according to predefined criteria. QoL was evaluated by EORTC QLQ-C30 and QLQ-CR38 questionnaires at admission, after n-RCT and 1, 6, 12, and 36 months after surgery. RESULTS: No statistically significant differences in QoL evaluation were observed between the two groups, both at admission and after n-RCT. In short term (1-6 months) period, significantly better results were observed in ELRR group by QLQ-C30 in global health status (p = 0.03), physical functioning (p = 0.026), role functioning (p = 0.04), emotional functioning (p = 0.04), cognitive functioning, fatigue (p < 0.05), dyspnoea (p < 0.001), insomnia (p < 0.05), appetite loss (p < 0.05), constipation (≤ 0.05), and by QLQ-CR38 in: body image (p = 0.03) and defecation (p = 0.025). At 1 year, the two groups were homogenous as assessed by QLQ-C30, whereas the QLQCR38 still showed better results of ELRR versus LTME in body image (p = 0.006), defecation problems (p = 0.01), and weight loss (p = 0.005). At 3 years, no statistically significant differences were observed between the two groups. CONCLUSIONS: In selected patients with rectal cancer, who underwent ELRR by TEM or LTME, QoL tests at 3 years do not show any statistical differences on examined items.

Transanal Endoscopic Microsurgery with or without Completion Total Mesorectal Excision for T2 and T3 Rectal Carcinoma.

AIM: Transanal endoscopic microsurgery (TEM) is used for the resection of large rectal adenomas and well or moderately differentiated T1 carcinomas. Due to difficulty in preoperative staging, final pathology may reveal a carcinoma not suitable for TEM. Although completion total mesorectal excision is considered standard of care in T2 or more invasive carcinomas, this completion surgery is not always performed. The purpose of this article is to evaluate the outcome of patients after TEM-only, when completion surgery would be indicated. METHODS: In this retrospective multicenter, observational cohort study, outcome after TEM-only (n = 41) and completion surgery (n = 40) following TEM for a pT2-3 rectal adenocarcinoma was compared. RESULTS: Median follow-up was 29 months for the TEM-only group and 31 months for the completion surgery group. Local recurrence rate was 35 and 11% for the TEM-only and completion surgery groups respectively. Distant metastasis occurred in 16% of the patients in both groups. The 3-year overall survival was 63% in the TEM-only group and 91% in the completion surgery group respectively. Three-year disease-specific survival was 91 versus 93% respectively. CONCLUSIONS: Although local recurrence after TEM-only for pT2-3 rectal cancer is worse compared to the recurrence that occurs after completion surgery, disease-specific survival is comparable between both groups. The lower unadjusted overall survival in the TEM-only group indicates that TEM-only may be a valid alternative in older and frail patients, especially when high morbidity of completion surgery is taken into consideration. Nevertheless, completion surgery should always be advised when curation is intended.

Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study).

OBJECTIVE: Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas. DESIGN: Patients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital. RESULTS: Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective. CONCLUSION: Under the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

Outcomes of Closed Versus Open Defects After Local Excision of Rectal Neoplasms: A Multi-institutional Matched Analysis.

BACKGROUND: The management of the rectal wall defect after local excision of rectal neoplasms remains controversial, and the existing data are equivocal. OBJECTIVE: This study aimed to determine the effect of open versus closed defects on postoperative outcomes after local excision of rectal neoplasms. DESIGN: Data from 3 institutions were analyzed. Propensity score matching was performed in one-to-one fashion to create a balanced cohort comparing open and closed defects. SETTINGS: This study was conducted at high-volume specialist referral hospitals. PATIENTS: Adult patients undergoing local excision via transanal endoscopic surgery from 2004 to 2016 were included. Patients were assigned to open- and closed-defect groups, and further stratified by full- or partial-thickness excision. INTERVENTION: Closure of the rectal wall defect was performed at the surgeon's discretion. MAIN OUTCOME MEASURES: The primary outcome measured was the incidence of 30-day complications. RESULTS: A total of 991 patients were eligible (593 full-thickness excision with 114 open and 479 closed, and 398 partial-thickness excision with 263 open and 135 closed). After matching, balanced cohorts consisting of 220 patients with full-thickness excision and 210 patients with partial-thickness excision were created. Operative time was similar for open and closed defects for both full-and partial-thickness excision. The incidence of 30-day complications was similar for open and closed defects after full- (15% vs. 12%, p = 0.432) and partial-thickness excision (7% vs 5%, p = 0.552). The total number of complications was also similar after full- or partial-thickness excision. Patients undergoing full-thickness excision with open defects had a higher incidence of clinically significant bleeding complications (9% vs 3%, p = 0.045). LIMITATIONS: Data were obtained from 3 institutions with different equipment and perioperative management over a long time period. CONCLUSIONS: There was no difference in overall complications between open and closed defects for patients undergoing local excision of rectal neoplasms, but there may be more bleeding complications in open defects after full-thickness excision. A selective approach to defect closure may be appropriate. See Video Abstract at http://links.lww.com/DCR/A470.