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Serra-Aracil et al. Mini-invasive Surg 2019;3:37  I  http://dx.doi.org/10.20517/2574-1225.2019.36                                 Page 3 of 11

               intention (benign tumors), which, after US and MRI, are staged US-MRI,T0-1 and US-MRI,N0; Group II,
               with curative intent (low grade adenocarcinomas, US-MRI,T0-1 and US-MRI,N0); Group III, consensus
               indication (low grade adenocarcinomas, US-MRI,T2 and US-MRI,N0) who reject radical surgery; Group
                                                           [11]
               IV, palliative care; and Group V, atypical indication .
               Inclusion criteria were patients in preoperative indication Groups I-IV who were candidates for TEM
               surgery.

               Exclusion criteria were patients in preoperative indication Group V, and those who, after intraoperative
               assessment of possible TEM, were assigned to abdominal surgery on technical grounds.

               Preoperative preparation, surgical technique, and postoperative evolution
                             [10]
               In our protocol , all patients with indication for TEM undergo anterograde mechanical preparation
               of the colon together with antibiotic and thromboembolic prophylaxis. General anesthetic is applied in
               most cases, unless the anesthesiologist decides to use spinal anesthesia due to the patient’s condition. The
               techniques used for local rectal excision are either TEM (Richard Wolf, Knittlingen, Germany) or TEO (Karl
               Storz GmbH, Tüttlingen, Germany). Full wall resection is performed by ultrasound scalpel, following the
               superficial plane of the perirectal fat.


               The lesion’s defect on the rectal wall should be sutured to prevent complications due to stenosis of the rectal
               lumen (in large defects) and postoperative bleeding due to fecal erosions. A long-lasting 3-0 absorbable
               monofilament suture such as polydioxanone (PDS, MonoPlus) is used with a 20-22 gauge curved cylindrical
               atraumatic needle. A 10 cm length is cut to facilitate handling in the interior of the rectoscope. A Vicryl
               (Ethicon) clip is placed at the ends, using an instrument known as Lapra-TY for placement, as an anchor
               and to avoid knot tying. A curved needle holder is used, which facilitates handling the suture.

               The suture should always be made in a transverse direction to avoid compromising the rectal lumen and
               to avoid formation of stenosis. The stitches are placed as full-thickness continuous sutures that are passed
               through the rectal wall, as previously described. Upon completion of suturing, irrigate once again with
               povidone iodine solution diluted to 1% with physiological saline solution.

               The bladder catheter is removed at the end of the surgery. Oral diet and ambulation are initiated after 6 h,
               and patients are discharged after 24 h unless they present complications.

               Main variable
               The main variable was post-surgical complications in patients undergoing TEO/TEM within 30 days of the
               intervention.


               Secondary variables
               The secondary variables were epidemiological, preoperative (patient- and tumor-dependent variables),
                                                                   [7]
               surgical, postoperative (Clavien-Dindo Classification, Table 1) , and pathological variables.

               In addition, postoperative morbidity (postoperative complications or adverse effects), defined as an
               unexpected consequence or injury caused to the patient due to the treatment, not due to their underlying
               disease, was evaluated. Morbidity was considered clinically relevant with a Cl-D grade ≥ II requiring
               specific medical action.


               Rectal bleeding was defined as more than 100 mL of red blood, or a bowel movement completely of blood
               (evaluated by nurse or surgeon). The same criteria were applied to patients consulting the emergency
               department.
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