Recently, an increase in well-differentiated rectal neuroendocrine tumors (WRNETs) has been noted. We aimed to evaluate transanal endoscopic microsurgery (TEM) for the treatment of WRNETs.
Between December 1995 and August 2009, 109 patients with WRNETs underwent TEM. TEM was performed for patients with tumors sizes of up to 20 mm and without a lymphadenopathy. These patients had been referred from other clinics after having been diagnosed with WRNETs by using a colonoscopic biopsy; they had undergone a failed endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) and exhibited an involved resection margin and remaining tumor after ESD or EMR, regardless of the distance from the anal verge. This study included 38 patients that had more than three years of follow-up.
The mean age of the patients was 51.3 ± 11.9 years, the mean tumor size was 8.0 ± 3.9 mm, and no morbidity occurred. Thirty-five patients were asymptomatic. TEM was performed after a colonoscopic resection in 13 cases because of a positive resection margin, a residual tumor or a non-lifting lesion. Complete resections were performed in 37 patients; one patient with a positive margin was considered surgically complete. In one patient, liver metastasis and a recurrent mesorectal node occurred after five and 10 years, respectively.
TEM might provide an accessible and effective treatment either as an initial or as an adjunct after a colonoscopic resection for a WRNET.
Well-differentiated rectal neuroendocrine tumors; Transanal endoscopic microsurgery; Colonoscopic resection; Treatment
Neoadjuvant chemoradiation has become the standard treatment in locally advanced rectal cancer (LARC) and improves local control. This study explored the feasibility of an intensified chemoradiation treatment followed by one cycle of capecitabine before surgery for LARC.
Methods and materials
Patients with histologically confirmed, newly diagnosed, locally advanced rectal adenocarcinoma (cT3-T4 and/or cN+) located within 12 cm of the anal verge were included in this study. Patients received intensity-modulated radiation therapy (IMRT) to the pelvis (total dose 44 Gy in 20 fractions), as well as concurrent oxaliplatin (50 mg/m2 d1 weekly) and capecitabine (625 mg/m2 b.i.d. d1–5 weekly). One cycle of capecitabine (1000 mg/m2 b.i.d. d1–14) was given two weeks after the completion of concomitant chemoradiation, and radical surgery was scheduled six weeks after chemoradiation.
Between October 2007 and November 2008, a total of 42 patients were enrolled in the study (median age 51 years; 31 male). Of these, 38 underwent surgical resection and 4 refused radical surgery because of almost complete primary tumor regression and complete symptom relief after neoadjuvant therapy. Fifteen patients underwent sphincter-sparing lower anterior resection. Six patients had a pathological complete response (pCR). The incidence of grade 3 hematologic, gastro-intestinal, and skin toxicities were 4.7%, 14.3%, and 26.2%, respectively. Grade 4 toxicity was not observed. Surgical complications (incisional infection within 2–3 weeks after surgery) were observed in 5 patients. Good responders (defined as TRG 3–4) had a significant difference in DFS (81.6% vs. 16.8%, respectively; p = 0.000) and OS (83.9% vs. 40.7%, respectively; p = 0.007) compared to those who were evaluated as TRG 1–2.
Our study indicates that neoadjuvant chemoradiation followed by one cycle of capecitabine before surgery has a good treatment efficacy, with only mild toxicities associated with chemoradiation and acceptable surgical complications. Treatment response was an early surrogate marker and correlated to oncologic prognosis.
Rectal cancer; Intensity-modulated radiation therapy; Neoadjuvant chemoradiotherapy
Treatment of rectal cancer requires a multidisciplinary approach with standardized surgical, pathological and radiotherapeutic procedures. Sphincter preserving surgery for cancer of the lower rectum needs a long-course of neoadjuvant treatments to reduce tumor volume, to induce down-staging that increases circumferential resection margin, and to facilitate surgery.
To evaluate the rate of anal sphincter preservation in low lying, resectable, locally advanced rectal cancer and the resectability rate in unresectable cases after neoadjuvent chemoradiation by oral Capecitabine.
Patients and methods
This trial included 43 patients with low lying (4–7 cm from anal verge) locally advanced rectal cancer, of which 33 were resectable. All patients received preoperative concurrent chemoradiation (45 Gy/25 fractions over 5 weeks with oral capecitabine 825 mg/m2 twice daily on radiotherapy days), followed after 4–6 weeks by total mesorectal excision technique.
Preoperative chemoradiation resulted in a complete pathologic response in 4 patients (9.3%; 95% CI 3–23.1) and an overall downstaging in 32 patients (74.4%; 95% CI 58.5–85). Sphincter sparing surgical procedures were done in 20 out of 43 patients (46.5%; 95% CI 31.5–62.2). The majority (75%) were of clinical T3 disease. Toxicity was moderate and required no treatment interruption. Grade II anemia occurred in 4 patients (9.3%, 95% CI 3–23.1), leucopenia in 2 patients (4.7%, 95% CI 0.8–17) and radiation dermatitis in 4 patients (9.3%, 95% CI 3–23.1) respectively.
In patients with low lying, locally advanced rectal cancer, preoperative chemoradiation using oral capecitabine 825 mg/m2, twice a day on radiotherapy days, was tolerable and effective in downstaging and resulted in 46.5% anal sphincter preservation rate.
Clinical implementation and widespread application of natural orifice translumenal surgery (NOTES) has been limited by the lack of specialized endoscopic equipment, which has prevented the ability to perform complex procedures including colorectal resections. Relative to other types of translumenal access, transanal NOTES using transanal endoscopic microsurgery (TEM) provides a stable platform for endolumenal and direct translumenal access to the peritoneal cavity, and specifically to the colon and rectum. Completely NOTES transanal rectosigmoid resection using TEM, with or without transgastric endoscopic assistance, was demonstrated to be feasible and safe in a swine survival model. The same technique was successfully replicated in human cadavers using commercially available TEM, with endoscopic and laparoscopic instrumentation. This approach also permitted complete rectal mobilization with total mesorectal excision to be performed completely transanally. As in the swine model, transgastric and/or transanal endoscopic assistance extended the length of proximal colon mobilized and overcame some of the difficulties with TEM dissection including limited endoscopic visualization and maladapted instrumentation. This extensive laboratory experience with NOTES transanal rectosigmoid resection served as the basis for the first human NOTES transanal rectal cancer excision using TEM and laparoscopic assistance. Based on this early clinical experience, NOTES transanal approach using TEM holds significant promise as a safe and substantially less morbid alternative to conventional colorectal resection in the management of benign and malignant colorectal diseases. Careful patient selection and substantial improvement in NOTES instrumentation are critical to optimize this approach prior to widespread clinical application, and may ultimately permit completely NOTES transanal colorectal resection.
Colorectal diseases; Transanal endoscopic microsurgery; Natural orifice translumenal endoscopic surgery
Since its introduction in 1983, transanal endoscopic microsurgery (TEM) has emerged as a safe and effective method to treat rectal lesions including benign tumors, early rectal cancer, and rectal fistulas and strictures. This minimally invasive technique offers the advantages of superior visualization of the lesion and greater access to proximal lesions with lower margin positivity and specimen fragmentation and lower long-term recurrence rates over traditional transanal excision. In addition, over two decades of scientific data support the use of TEM as a viable alternative to radical excision of the rectum with less morbidity, faster recovery, and greater potential cost savings when performed at specialized centers.
Capecitabine is an attractive oral chemotherapeutic agent that has a radiosensitizing effect and tumor-selectivity. This study was performed to evaluate the efficacy and toxicity of preoperative chemoradiation therapy, when used with oral capecitabine, for locally advanced rectal cancer.
Materials and Methods
A prospective phase II trial of preoperative chemoradiation for locally advanced adenocarcinomas of the lower two-thirds of the rectum was conducted. A radiation dose of 50 Gy over five weeks and a daily dose of 1650 mg/m2 capecitabine in two potions was administered during the entire course of radiation therapy. Surgery was performed with standardized total mesorectal excision four to six weeks after completion of the chemoradiation.
Between January 2002 and September 2003, 61 patients were enrolled onto this prospective phase II trial. The pretreatment clinical stages were T3 in 64% (n=39), T4 in 36% (n=22) and N1-2 in 82% (n=50) of these patients. Fifty-six (92%) patients completed the chemoradiation as initially planned and a complete resection performed in 58 (95%). Down-staging was observed in 45 patients (74%) and a pathologic complete response in 6 (10%). Among the 37 patients with tumors located within 5 cm from the anal verge on colonoscopy, 27 (73%) underwent a sphincter-preserving procedure. No grade 3 and 4 proctitis or hematological toxicities were observed.
Preoperative chemoradiation therapy with capecitabine achieved encouraging rates of tumor downstaging and sphincter preservation, with a low toxicity profile. This combined modality can be regarded as a safe and effective treatment for locally advanced rectal cancer.
Rectal cancer; Preoperative; Chemoradiotherapy; Capecitabine
Transanal endoscopic microsurgery as a local therapy option for rectal neoplasms is a tissue-sparing technique that protects the anal sphincter. The present retrospective analysis reports the course of observation after local excision of adenomas and T1 low-risk carcinomas using transanal endoscopic microsurgery.
In a retrospective analysis we examined data on 279 patients for local recurrence. A total of 144 patients had a rectal adenoma (n = 103) or a R0 resection of low-risk T1 carcinomas (n = 41). In this collective, we also examined parameters concerning perioperative management, complications, intraoperative blood loss and duration of hospital stay.
Patients with adenoma were on average 64.9 (range 37 to 90) years old; 83.5% of the adenomas were located 3 to 11 cm from the anocutaneous line. In adenoma patients the recurrence rate was 2.9% for an observation period of 21.8 months. The postoperative course was without any complications in 98.1% of patients.
Patients with T1 low-risk carcinoma were 64.6 (range 30 to 89) years old. In all cases, an R0 resection could be performed. The recurrence rate was 9.8% for an observation period of 34.4 months. In this group the postoperative course was free of complications in 97.6% of patients.
The high efficacy of transanal endoscopic microsurgery ensures minimally invasive treatment of adenomas and low-risk T1 carcinomas with low complication rates and a low rate of therapeutic failure.
Transanal endoscopic microsurgery; Rectal adenoma; Rectal carcinoma; Local excision; Endoscopic surgery
INTRODUCTION: The objective was to assess the impact on the management of colorectal patients treated in a district general hospital within the first year after the introduction of transanal endoscopic microsurgery (TEM). PATIENTS AND METHODS: Data were collected for consecutive unselected patients who underwent TEM. Comparative data were derived from a matched group of patients who underwent anterior resection, peranal procedures (PAR) or transanal resection (TAR) in this unit. RESULTS: Twenty-two patients underwent TEM (11 men and 11 women; aged, 29-87 years; median, 75 years). Eighteen patients had a pre-operative diagnosis of benign rectal neoplasms; three were found to have invasive carcinoma, which might have been missed during TAR. Four patients had a pre-operative diagnosis of rectal cancer and TEM provided local tumour control in three cases. The operating time ranged between 20-150 min (mean, 65 min; median, 57 min). Hospital stay ranged between 0-10 days (mean, 3.7 days; median, 3 days), with a total of 97 in-patient days for the entire group of patients. Twenty-four operations were performed (22 TEM and two salvage anterior resections), with an estimated cost of 1544 pounds sterling for consumables used. Alternative treatments in the absence of TEM were considered to involve 10 anterior resections, 5 closures of ileostomy, 30 TAR procedures and one PAR procedure, with an estimated 306 days of in-patient admission, 46 operations and 6245 pounds sterling spent on consumables. CONCLUSIONS: Availability of TEM allows more efficient treatment for a significant number of patients with rectal tumours. The cost of the equipment is offset by a significant decrease in the length of in-patient admissions.
To evaluate rate of pathologic complete response (pCR) and toxicity of two neoadjuvant chemoradiation (chemoRT) regimens for T3/T4 rectal cancer in a randomized phase II study.
Methods and Materials
Patients with T3 or T4 rectal cancer < 12 cm from the anal verge were randomized to preoperative RT (50.4 Gy in 1.8 Gy fractions) with (1) concurrent capecitabine (1200 mg/m2/d M-F) and irinotecan (50 mg/m2 weekly × 4 doses) (arm 1), or (2) concurrent capecitabine (1650 mg/m2/d M-F) and oxaliplatin (50 mg/m2 weekly × 5 doses) (arm 2). Surgery was performed 4–8 weeks after chemoRT, and adjuvant chemotherapy 4–6 weeks after surgery. The primary endpoint was pCR rate, requiring 48 evaluable patients per arm.
146 patients were enrolled. Protocol chemotherapy was modified due to excessive GI toxicity after treatment of 35 patients; 96 were assessed for the primary endpoint—final regimen described above. Patient characteristics were similar for both arms. Following chemoRT, tumor downstaging was 52% and 60%, and nodal downstaging (excluding N0 patients) was 46% and 40%, for arms 1 and 2, respectively. The pCR rate for arm 1 was 10% and for arm 2 was 21%. For arms 1 and 2, respectively, preop chemoRT grade 3/4 hematologic toxicity was 9% and 4%, and grade 3/4 non-hematologic toxicity was 26% and 27%.
Preoperative chemoRT with capecitabine plus oxaliplatin for distal rectal cancer has significant clinical activity (10/48 pCRs) and acceptable toxicity. This regimen is currently being evaluated in a phase III randomized trial (NSABP R04).
Neoadjuvant; chemotherapy; radiation; rectal; cancer
Transanal excision of rectal polyps with laparoscopic instrumentation and a single incision laparoscopic port is a novel technique that uses technology originally developed for abdominal procedures from the natural orifice of the rectum. Transanal endoscopic microsurgery (TEM) is a well established surgical approach for certain benign or early malignant lesions of the rectum, under specific indications. Our technique is a hybrid technique of transanal surgery, a reasonable method for polyp resection without the need of the sophisticated and expensive instrumentation of TEM which can be applied whenever endoscopic or conventional transanal surgical removal is not feasible.
Polypectomy; SILS; Transanal endoscopic microsurgery; Laparoscopy; Endoscopy
AIM: To evaluate the status of anorectal function after repeated transanal endoscopic microsurgery (TEM).
METHODS: Twenty-one patients undergoing subtotal colectomy with ileorectal anastomosis were included. There were more than 5 large (> 1 cm) polyps in the remaining rectum (range: 6-20 cm from the anal edge). All patients, 19 with villous adenomas and 2 with low-grade adenocarcinomas, underwent TEM with submucosal endoscopic excision at least twice between 2005 and 2011. Anorectal manometry and a questionnaire about incontinence were carried out at week 1 before operation, and at weeks 2 and 3 and 6 mo after the last operation. Anal resting pressure, maximum squeeze pressure, maximum tolerable volume (MTV) and rectoanal inhibitory reflexes (RAIR) were recorded. The integrity and thickness of the internal anal sphincter (IAS) and external anal sphincter (EAS) were also evaluated by endoanal ultrasonography. We determined the physical and mental health status with SF-36 score to assess the effect of multiple TEM on patient quality of life (QoL).
RESULTS: All patients answered the questionnaire. Apart from negative RAIR in 4 patients, all of the anorectal manometric values in the 21 patients were normal before operation. Mean anal resting pressure decreased from 38 ± 5 mmHg to 19 ± 3 mmHg (38 ± 5 mmHg vs 19 ± 3 mmHg, P = 0.000) and MTV from 165 ± 19 mL to 60 ± 11 mL (165 ± 19 mL vs 60 ± 11 mL, P = 0.000) at month 3 after surgery. Anal resting pressure and MTV were 37 ± 5 mmHg (38 ± 5 mmHg vs 37 ± 5 mmHg, P = 0.057) and 159 ± 19 mL (165 ± 19 mL vs 159 ± 19 mL, P = 0.071), respectively, at month 6 after TEM. Maximal squeeze pressure decreased from 171 ± 19 mmHg to 62 ± 12 mmHg (171 ± 19 mmHg vs 62 ± 12 mmHg, P = 0.000) at week 2 after operation, and returned to normal values by postoperative month 3 (171 ± 19 vs 166 ± 18, P = 0.051). RAIR were absent in 4 patients preoperatively and in 12 (χ2 = 4.947, P = 0.026) patients at month 3 after surgery. RAIR was absent only in 5 patients at postoperative month 6 (χ2 = 0.141, P = 0.707). Endosonography demonstrated that IAS disruption occurred in 8 patients, and 6 patients had temporary incontinence to flatus that was normalized by postoperative month 3. IAS thickness decreased from 1.9 ± 0.6 mm preoperatively to 1.3 ± 0.4 mm (1.9 ± 0.6 mm vs 1.3 ± 0.4 mm, P = 0.000) at postoperative month 3 and increased to 1.8 ± 0.5 mm (1.9 ± 0.6 mm vs 1.8 ± 0.5 mm, P = 0.239) at postoperative month 6. EAS thickness decreased from 3.7 ± 0.6 mm preoperatively to 3.5 ± 0.3 mm (3.7 ± 0.6 mm vs 3.5 ± 0.3 mm, P = 0.510) at month 3 and then increased to 3.6 ± 0.4 mm (3.7 ± 0.6 mm vs 3.6 ± 0.4 mm, P = 0.123) at month 6 after operation. Most patients had frequent stools per day and relatively high Wexner scores in a short time period. While actual fecal incontinence was exceptional, episodes of soiling were reported by 3 patients. With regard to the QoL, the physical and mental health status scores (SF-36) were 56.1 and 46.2 (50 in the general population), respectively.
CONCLUSION: The anorectal function after repeated TEM is preserved. Multiple TEM procedures are useful for resection of multi-polyps in the remaining rectum.
Familial adenomatous polyposis; Repeated transanal endoscopic microsurgery; Anorectal function; Anorectal manometry; Subtotal colectomy
Limited data suggest that extracapsular lymph node involvement (LNI) has a negative prognostic impact in gastrointestinal malignancies. The aim of this study was to assess the prevalence and prognostic impact of LNI in patients with primary resected rectal cancer. Between 1997 and 2007, 243 rectal cancer patients underwent surgical therapy without neoadjuvant treatment at our Department. Of these, 12 (5%) patients received transanal endoscopic microsurgery and were not included for further analyses. In the remaining patients, a (low) anterior resection was performed in 79% and an abdominoperineal rectal amputation in 21%. The total number of analyzed lymph nodes and the number of metastatic lymph nodes with/without extracapsular LNI were determined and the prognostic impact of LNI was assessed. The median number of analyzed lymph nodes was 14. In total, 59% of patients were node-negative, 18% of patients were node-positive without extracapsular LNI and 23% of patients were node-positive with extracapsular LNI. A positive lymph node status with extracapsular LNI was significantly correlated with a poorer T-, N- and M-category, grading and more frequent lymphatic vessel infiltration compared with node-negative or node-positive without extracapsular LNI patients (p<0.001). The overall 5-year survival rate of node-negative patients was 75%, for node-positive without extracapsular LNI patients 69% and for node-positive with extracapsular LNI patients 36% (p<0.001). By multivariate analysis, the N-category with extracapsular LNI was characterized as an independent prognostic factor. Extracapsular lymph node involvement reveals an independent negative prognostic impact in patients with rectal cancer undergoing surgical therapy. Staging systems for rectal cancer should include the implementation of extracapsular lymph node involvement.
rectal cancer; prognostic factors; extracapsular lymph node involvement; adjuvant therapy
Neoadjuvant chemoradiation therapy followed by curative surgery has gained acceptance as the therapy of choice in locally advanced rectal cancer. However, deterioration of anorectal function after long-course neoadjuvant chemoradiation therapy combined with surgery for rectal cancer is poorly defined. The aim of this study was to evaluate the physiological and clinical change of anorectal function after neoadjuvant chemoradiation therapy for rectal cancer.
We analyzed 30 patients on whom preoperative anorectal manometry data were available both before and after chemoradiation from October 2010 to September 2011. All patients underwent long-course neoadjuvant chemoradiation therapy. We compared manometric parameters between before and after neoadjuvant chemoradiation therapy.
Of 30 patients, 20 were males and 10 females. The mean age was 64.9 ± 9.9 years (range, 48-82). Before nCRT, the rectal compliance was higher in patients with ulceroinfiltrative type (P = 0.035) and greater involvement of luminal circumference (P = 0.017). However, there was the tendency of increased rectal sensory threshold for desire to defecate when the patient had decreased circumferential ratio of the tumor (P = 0.099), down-graded T stage (P = 0.016), or reduced tumor volume (P = 0.063) after neoadjuvant chemoradiation.
Neoadjuvant chemoradiation therapy did not significantly impair overall sphincter function before radical operation. The relationship between tumor response of chemoradiation and sensory threshold for desire to defecate may suggest that neoadjuvant chemoradiation may be helpful for defecatory function as well as local disease control, at least in the short-term period after the radiation in locally advanced rectal cancer patients.
Anorectal function; Neoadjuvant chemoradiation; Manometry; Rectal cancer
Anastomotic leak after low anterior resection (LAR) in patients with rectal cancer who have received neoadjuvant chemoradiation can be challenging to treat and can lead to the creation of a permanent stoma. We report the case of a post-operative anastomotic leak after a Baker-type anastomosis during a low anterior resection was successfully managed with transanal endoscopic microsurgical (TEM) debridement and repair. TEM can be a successful endoluminal alternative treatment in the management of anastomotic leak after LAR and can prevent the morbidity associated with re-exploration and colostomy.
We analyzed the effect of neoadjuvant chemoradiation on feasibility and outcomes in rectal cancer patients undergoing laparoscopic resection of the rectum.
This was a retrospective analysis of a consecutive series of laparoscopic resections for rectal cancer from 1998 to 2004 (N=60).
Eight patients received preoperative chemoradiation therapy (neoadjuvant group) for rectal cancer and 52 patients did not (primary surgical group). The conversion rate was higher in the neoadjuvant group, but this did not reach statistical significance (3/8, 37% in the neoadjuvant group vs. 7/52, 13% in the primary surgical group, P=0.12). Operative time was longer in the neoadjuvant group (170±60 vs 228±70 min, P=0.03). Complication rates (3/52, 5.7% in the primary surgical vs. 0% in the neoadjuvant group, P=1.0), and a median number of resected lymph nodes (14.5 in the primary surgical vs. 16.0 in the neoadjuvant group, P=0.81) were similar between groups.
Laparoscopic resection of rectal cancer in patients after preoperative chemoradiation treatment seems to be associated with a higher conversion rate and a longer duration of surgery. No change in mortality and morbidity was detected. We encourage further investigation of laparoscopic rectal surgery for treatment of rectal cancer.
Rectal cancer; Laparoscopic resection; Neoadjuvant chemoradiation
Transanal endoscopic video-assisted excision of benign and malignant rectal lesions with pneumorectal distension appears to optimize the visual field and avert several of the pitfalls commonly associated with transanal endoscopic microsurgery.
Transanal endoscopic microsurgery is a safe and efficacious surgical approach for local excision of benign adenomas and early-stage rectal cancer. However, utilization of the technique has been limited due to the unavailability of high-priced specialized instrumentation at many institutions and the technically demanding training required. To avoid these obstacles, we have explored an alternative approach called Transanal Endoscopic Video-Assisted excision, which combines the merits of single-port access and local transanal excision.
A disposable single-incision port is inserted into the anal canal for transanal access. The port contains 3 cannulae for introducing instrumentation into the rectal lumen, and a supplementary cannula for carbon dioxide insufflation. Pneumorectum results in rectal distention and optimizes the visual field during the procedure. Standard laparoscopic instrumentation is utilized for visualization and transanal excision of rectal pathologies.
Transanal endoscopic video-assisted excision is an innovative approach to local excision of benign and malignant rectal lesions. The approach averts several of the pitfalls commonly experienced with transanal endoscopic microsurgery. Continued investigation and development of this novel modality will be important in establishing its role in minimally invasive surgery.
Anal canal; Laparoscopy; Microsurgery; Rectal neoplasms
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.
The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.
Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.
Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.
The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
Trial registration number
In this review article the surgical technique of Transanal Endoscopic Microsurgery (TEMS) is examined. A number of techniques have been used to treat adenomas of the rectum. The treatment of large adenomas which occupy a large surface of the rectal lumen or adenomas which are flat and grow in a "carpet-like" fashion is particularly challenging. Major rectal surgery carries a risk of morbidity and mortality, particularly in elderly and unfit patients. Although local excision with transanal resection (TAR) and the Kraske sacral operation have been used in the past, during the last twenty years TEMS has become the method of choice for those lesions. TEMS is efficient and minimally invasive. The technique allows the patient to recover rapidly and the incidence of complications is much lower than that of major surgery. In case of recurrence the option of repeat TEMS or major surgery remain available. TEMS has been slow to gain popularity mainly for reasons of cost and steep learning curve but it is now an established procedure and a valuable therapeutic option which is particularly useful for elderly and unfit patients. Gastroenterologists should be aware of the nature and indications of TEMS in order to advise and refer selected patients with rectal adenomas accordingly.
Geographic Information Systems (GIS) have been used in a wide variety of applications to integrate data and explore the spatial relationship of geographic features. Traditionally this has referred to features on the surface of the earth. However, it is possible to apply GIS in medicine, at the scale of the human body, to visualize and analyze anatomic and clinical features.
In the present study we used GIS to examine the findings of transanal endoscopic microsurgery (TEM), a minimally-invasive procedure to locate and remove both benign and cancerous lesions of the rectum. Our purpose was to determine whether anatomic features of the human rectum and clinical findings at the time of surgery could be rendered in a GIS and spatially analyzed for their relationship to clinical outcomes.
Maps of rectal topology were developed in two and three dimensions. These maps highlight anatomic features of the rectum and the location of lesions found on TEM. Spatial analysis demonstrated a significant relationship between anatomic location of the lesion and procedural failure.
This study demonstrates the feasibility of rendering anatomical locations and clinical events in a GIS and its value in clinical research. This allows the visualization and spatial analysis of clinical and pathologic features, increasing our awareness of the relationship between anatomic features and clinical outcomes as well as enhancing our understanding and management of this disease process.
AIM: To compare the sensitivity and specificity of two imaging techniques, endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI), in patients with rectal cancer after neoadjuvant chemoradiation therapy. And we compared EUS and MRI data with histological findings from surgical specimens.
METHODS: Thirty-nine consecutive patients (51.3% Male; mean age: 68.2 ± 8.9 years) with histologically confirmed distal rectal cancer were examined for staging. All patients underwent EUS and MRI imaging before and after neoadjuvant chemoradiation therapy.
RESULTS: After neoadjuvant chemoradiation, EUS and MRI correctly classified 46% (18/39) and 44% (17/39) of patients, respectively, in line with their histological T stage (P > 0.05). These proportions were higher for both techniques when nodal involvement was considered: 69% (27/39) and 62% (24/39). When patients were sorted into T and N subgroups, the diagnostic accuracy of EUS was better than MRI for patients with T0-T2 (44% vs 33%, P > 0.05) and N0 disease (87% vs 52%, P = 0.013). However, MRI was more accurate than EUS in T and N staging for patients with more advanced disease after radiotherapy, though these differences did not reach statistical significance.
CONCLUSION: EUS and MRI are accurate imaging techniques for staging rectal cancer. However, after neoadjuvant RT-CT, the role of both methods in the assessment of residual rectal tumors remains uncertain.
Endoscopic ultrasound; Magnetic resonance imaging; Rectal cancer; Neoadjuvant chemoradiation therapy; Diagnostic accuracy
Transanal endoscopic microsurgery (TEM) is a minimal invasive technique for local excision of rectal tumours. The procedure is performed via a rectoscope with a diametre of 4 cm. The aim of this prospective study was to assess both functional outcome and quality of life after TEM.
Patients and methods
Between 2004 and 2006, 47 patients were studied prior to and at least 6 months after TEM. Demographics, operative details and post-operative complications were recorded. Functional outcome was determined using the Faecal Incontinence Severity Index (FISI). Quality of life was measured using the EuroQol EQ-5D questionnaire and the Faecal Incontinence Quality of Life (FIQL) score.
Six months after surgery, median FISI score was found to be decreased (p
< 0.01), depicting an improvement in faecal continence. This improvement was most significant in tumours within 7 cm from the dentate line (p = 0.01). From the patients’ perspective, post-operative quality of life was found to be higher (p
< 0.02). A significant improvement was observed in two of the four FIQLS domains (embarrassment, p = 0.03; lifestyle, p = 0.05). The domains of lifestyle, coping and behaviour and embarrassment were correlated with the FISI (all p < 0.05).
This study indicates TEM has no deteriorating effect on faecal continence. Moreover, once the tumour has been excised using TEM, quality of life is improved.
Rectal neoplasms; TEM; Local excision; Quality of life; Functional outcome
Transanal endoscopic microsurgery was introduced in the early 1980s. Since then, increasing numbers of rectal adenomas are being excised by this technique. The aim of this study was to evaluate our institution's experience with transanal endoscopic microsurgery for rectal adenoma and carcinoma.
Seventy-five patients (adenomas, n=58) underwent more than 90 TEM resections over a period of 5 years.
Postoperative complications were minimal with 3% (n=2) in the adenoma group requiring transfusion and 0% 30-day mortality. One patient in each group developed transient fecal incontinence. During the follow-up period, 6 patients (10%) in the adenoma group underwent further local resections for their recurrences. Two patients in the carcinoma group (1 each of pathological T1 and T2 stage) developed recurrence at 24 months. A female with a T2 tumor was found to have an inoperable lesion and underwent sigmoid colostomy. Five of 17 patients had postoperative radiotherapy, and 2 patients developed radiation enteritis. Four patients died during follow-up due to unrelated reasons.
The transanal endoscopic microsurgery technique appears to be safe and associated with minimal morbidity. Careful selection of patients with thorough preoperative assessment is necessary for carcinoma patients. Patients with T1 lesions and favorable histology should only be considered for curative resection by this technique.
Transanal endoscopic microsurgery; Rectal adenoma; Rectal carcinoma; Local resection
Introduction. Despite initial enthusiasm, the use of transanal endoscopic microsurgery (TEM) is still quite limited at present because of the expense of highly specialized equipment and the complexity of the learning curve. Furthermore, some authors report a relevant, although temporary, effect on anorectal function because of the considerable anal dilatation which can even produce a rupture of the internal anal sphincter. The “glove TEM” proposes itself as an alternative to traditional TEM that could settle these problems. Materials and Methods. The technique is accurately described together with the necessary equipment to perform it. Between 2011 and 2012, we operated eight patients with this technique for rectal adenomas or early carcinomas achieving R0 resection in all cases and reporting no early or late complications during the first five months of followup. Discussion. This technique offers multiple advantages compared to the original TEM. (i) It allows the use of all available laparoscopic instruments. (ii) It gives a great manoeuvrability of the instruments in contrast to rigid rectoscope systems. (iii) Given the limited length of the device, it permits to operate on tumors closer to the dentate line. (iv) It is less traumatic to the anal sphincter. It is definitively much cheaper. Conclusions. We believe that this new technique is easy to perform, cost-effective, and less traumatic to the anal sphincter compared to traditional TEM.
Transanal endoscopic microsurgery (TEM) was developed by G. Buess in 1983 as a minimally invasive surgery for the removal of anorectal lesions that cannot be excised by conventional transanal instruments. TEM uses specialized equipment including an operating proctoscope and insufflator to form an airtight system. We reviewed the experience of a single surgeon using this technique at our institution.
A retrospective and prospective review of all patients who underwent TEM between November 2002 and April 2007 by a single surgeon at our institution was performed. One hundred thirteen patients were identified. All 113 patients had a preoperative enema. Those with rectal lesions also underwent rectal endoscopic ultrasonography (REUS). A single dose of preoperative cefazolin and metronidazole was given before the start of all procedures. All patients were followed with flexible sigmoidoscopy at 1, 6, and 12 months.
A total of 113 patients underwent TEM excision between November 2002 and April 2007. Diagnoses included benign adenomas (64.6%), carcinoid tumors (14.6%), T1 cancers (18.8%), and a small number of T2 cancers (2.1%). The mean distance from the anal verge was 16 cm. Mean operative time was 79 minutes (range, 48–170 minutes). The average blood loss was 100 cc. The average length of hospital stay was less than 24 hours; 92 patients went home the same day. The longest length of stay was 7 days for a patient who had a long segment of carpet adenomas between 14–6 cm and the peritoneum was entered and subsequently closed. However, postoperatively, there was a question of peritoneal signs and the patient was explored. No spillage was found but the presence of clots was found. In one case, the procedure could not be completed due to a tortuous rectum and the patient underwent a low anterior resection instead. Two patients experienced postoperative bleeding that stopped without intervention and did not require transfusion. One patient developed a hematoma that drained on its own. In all cases, postoperative pain was controlled with oral narcotics. Eight patients had a recurrence of their lesion.
Endoscopic removal of adenomatous colorectal polyps during diagnostic procedures is the first-line treatment of such lesions. It is efficient, safe, relatively inexpensive, and associated with the lowest complication rate. However, this is not always possible due to size and/or location limitations. Additionally, adenomas in the middle or upper rectum are difficult to remove using standard transanal excision instruments. In our series, only 5 of 113 patients (4%) experienced any type of complication. These consisted of bleeding and hematoma. This finding is consistent with other evidence in the literature. TEM is an effective treatment for lesions between 6–18 cm. We believe that it is less invasive than abdominal surgery or the Kraske procedure. The need for conversion and the complication rates are low. It is a useful tool for surgeons to excise lesions that cannot be reached by traditional transanal instruments. Of the 8 patients who had recurrences, 6 were benign while 2 were malignant. The 2 patients with malignant recurrences were not candidates for abdominal surgery due to their comorbidities. TEM is adequate for the removal of rectal lesions, providing the patients are appropriate candidates for the procedure.
We sought to evaluate the efficacy and safety data of a combination regimen using weekly irinotecan in combination with capecitabine and concurrent radiotherapy (CapIri-RT) as neoadjuvant treatment in rectal cancer in a phase-II trial. Patients with rectal cancer clinical stages T3/4 Nx or N+ were recruited to receive irinotecan (50 mg m−2 weekly) and capecitabine (500 mg m−2 bid days 1–38) with a concurrent RT dose of 50.4 Gy. Surgery was scheduled 4–6 weeks after the completion of chemoradiation. A total of 36 patients (median age 62 years; m/f: 27:9) including three patients with local recurrence were enclosed onto the trial. The median distance of the tumour from the anal verge was 5 cm. The main toxicity observed was (NCI-CTC grades 1/2/3/4 (n)): Anaemia 23/9/−/−; leucocytopenia 12/7/7/2, diarrhoea 13/15/4/−, nausea/vomiting 9/10/2/−, and increased activity of transaminases 3/3/1/−. One patient had a reversible episode of ventricular fibrillation during chemoradiation, most probably caused by capecitabine. The relative dose intensity was (median/mean (%)): irinotecan 95/91, capecitabine 100/92). Thirty-four patients underwent surgery (anterior resection n=25; abdomino-perineal resection n=6; Hartmann's procedure n=3). R0-resection was accomplished in all patients. Two patients died in the postoperative course from septic complications. Pathological complete remission was observed in five out of 34 resected patients (15%), and nine patients showed microfoci of residual tumour (26%). After a median follow-up of 28 months one patient had developed a local recurrence, and five patients distant metastases. Three-year overall survival for all patients with surgery (excluding three patients treated for local relapse or with primary metastatic disease) was 80%. In summary, preoperative chemoradiation with CapIri-RT exhibits promising efficacy whereas showing managable toxicity. The local recurrence and distant failure rates observed after a median 28 months are low compared with standard 5-fluorouracil based therapy.
capecitabine; irinotecan; locally advanced rectal cancer; chemoradiotherapy