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IP 1184 [IPG514] NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of transanal total mesorectal excision of the rectum This procedure is used for patients who need to have their whole rectum removed (for example, patients with rectal cancer or chronic inflammatory bowel disease that has not responded well enough to medical treatment). The rectum is removed using instruments introduced through an access device placed into the anus, combined with laparoscopic (keyhole) surgery through the abdomen, rather than through a long incision in the lower abdomen or a standard laparoscopic procedure alone. Introduction The National Institute for Health and Care Excellence (NICE) has prepared this interventional procedure (IP) overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This IP overview was prepared in April 2014 and updated in November 2014. Procedure name Transanal total mesorectal excision of the rectum Specialist societies Association of Coloproctology of Great Britain and Ireland British Association of Surgical Oncology (BASO). IP overview: Transanal total mesorectal excision of the rectum Page 1 of 50 IP 1184 [IPG514] Description Indications and current treatment Transanal total mesorectal excision (TaTME) can be used to treat malignant or benign disease of the rectum. Malignant disease: The incidence of rectal cancer rises sharply with age. Symptoms include rectal bleeding and change in bowel habit, although the early stages may be asymptomatic. Treatment of rectal cancer depends on its stage which is conventionally assessed using Dukes’ classification system: stage A – confined to the lining of the rectum stage B – grown into the muscle wall stage C – spread to at least 1 lymph node in the area stage D – spread to another organ in the body. Surgery is the main treatment modality for patients with locally confined disease. It involves resection of the affected part of the rectum, with or without preservation of the anus (and formation of a colostomy when preservation of the anus is not technically possible). Adjunctive radiotherapy and chemotherapy may also be used to reduce the risk of local recurrence and prevent metastatic disease. Benign disease: Benign conditions that may lead to the need for resection of the rectum include ulcerative colitis and Crohn’s disease. Both are chronic conditions, characterised by periods of clinical relapse and remission. Treatment depends on the severity and extent of the disease and is aimed at reducing the frequency and severity of recurrences. Drug therapy, including corticosteroids and immunosuppressive agents (such as azathioprine), usually controls the disease adequately. For more severe cases, treatment with a monoclonal antibody (such as infliximab) may be considered. Surgical removal of the affected areas may be necessary for severe cases that do not respond to medical treatment. What the procedure involves TaTME aims to improve the clinical outcome of rectal excision, and to reduce the length of stay in hospital and morbidity after surgery. It may facilitate proctectomy that would be difficult by an open or laparoscopic approach in people with a narrow pelvis or high body mass index, or where the position of the tumour is low in the rectum. IP overview: Transanal total mesorectal excision of the rectum Page 2 of 50 IP 1184 [IPG514] Before surgery, the patient has bowel preparation and prophylactic antibiotics. With the patient under general anaesthesia and in the lithotomy position, standard laparoscopic mobilisation of the left colon and upper rectum is performed. After insertion of an operating platform into the anus, the lower rectum including the total mesorectum is mobilised in a reversed way using standard laparoscopic instruments. The transanal part of this procedure starts with insertion of a purse-string suture to close the rectal lumen, followed by a full thickness rectotomy. After identification of the total mesorectal excision (TME) plane, the dissection progresses proximally until connection is made with the dissection from above. The specimen can be removed through the transanal platform or, if the tumour is large, through the abdomen using a small incision. Anastomosis to connect the colon and the anus can be done using sutures (hand-sewn technique) or staples. When anastomosis is not possible, the patient is given a permanent stoma. When an anastomosis is done, a temporary ileostomy is usually created. Outcome measures Quality of the mesorectal excision. Quirke's grading assesses the quality of the mesorectal envelope from 3 indicating a completely intact specimen to 1 indicating an incomplete mesorectal envelope. It is assigned by pathologists. Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to transanal total mesorectal excision (TaTME) of the rectum. Searches were conducted of the following databases, covering the period from their commencement to 3 November 2014: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. IP overview: Transanal total mesorectal excision of the rectum Page 3 of 50 IP 1184 [IPG514] Table 1 Inclusion criteria for identification of relevant studies Characteristic Criteria Publication type Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patient Patients with benign or malignant rectal disease. Intervention/test Transanal total mesorectal excision of the rectum. Outcome Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Language Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. List of studies included in the IP overview This IP overview is based on approximately 275 patients from 2 non-randomised comparative studies1-2 and 8 case series3-10. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. IP overview: Transanal total mesorectal excision of the rectum Page 4 of 50 IP 1184 [IPG514] Table 2 Summary of key efficacy and safety findings on transanal total mesorectal excision of the rectum Study 1 Fernandez-Hevia M (2014) Details Study type Non-randomised comparative study Country Spain Recruitment period 2011-13 (for transanal TME) and 2010-2011 (for laparoscopic TME) Study population and number n=74 patients with middle or low rectal cancer (37 transanal TME versus 37 laparoscopic TME) Age and sex Transanal TME mean 64.5 ± 11.8 years; 65% (24/37) male. Laparoscopic TME mean 69.5 ± 10.5 years; 60% (22/37) male. Mean BMI: 23.7 kg/ m2 [range 18 to 31kg/ m2] (transanal TME) versus mean BMI: 25.1 kg/ m2 [range 15 to 31.6 kg/ m2] (laparoscopic TME) Patient selection criteria Transanal TME group: consecutive patients with middle or low rectal histologically confirmed adenocarcinoma located up to 10 cm from the anal verge. Laparoscopic TME: retrospective cohort of consecutive patients of identical characteristics as in the transanal TME group. Technique Patients received mechanical bowel cleansing the day before surgery. They also received antibiotic prophylaxis with 2 g of cefoxitin, or 400 mg of ciprofloxacin and 500 mg of metronidazole for patients allergic to penicillin, intravenously. Transanal TME: 2 surgical teams worked at the same time (1 performing the abdominal phase as for the laparoscopic group and 1 performing the perineal phase). The Lone star retractor (CooperSurgical Inc.) was used. In very low tumours, the retractor was used to do an intersphincteric dissection and then, the Gelpoint path Transanal Access Platform was inserted. After dissection, the specimen was extracted transanally. A handsewn coloanal anastomosis was done. In middle and low rectal tumours, the Gelpoint path Transanal Access Platform was positioned in the anal canal after the Lone start retractor was positioned. The rectal anastomosis was done with a circular stapler EEA 33 mm single-use stapler with 4.8 mm staples (Autosuture, Covidien). For large tumours, a bulky mesentery or a size mismatch between the rectum and the specimen, an assisted incision was used to extract the specimen (Pfannenstiel or previous incision). Laparoscopic TME: A Pfannenstiel was often used as an assisted incision. In some cases, the

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