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Page 4 of 11 Serra-Aracil et al. Mini-invasive Surg 2019;3:37 I http://dx.doi.org/10.20517/2574-1225.2019.36

Table 1. Clavien-Dindo classification [7]
Grade Definition
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical,
endoscopic, and radiological interventions
Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and
physiotherapy. This grade also includes wound infections opened at the bedside
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications
Blood transfusions and total parenteral nutrition are also included
Grade III Requiring surgical, endoscopic or radiological intervention
Intervention not under general anesthesia
Intervention under general anesthesia
Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU management
Grade IVa Single organ dysfunction (including dialysis)
Grade IVb Multiorgan dysfunction
Grade V Death of a patient
Suffix “d” If the patient suffers from a complication at the time of discharge (see examples in Table 2), the suffix “d” (for
“disability”) is added to the respective grade of complication. This label indicates the need for a follow-up to fully
evaluate the complication
*Brain hemorrhage, ischemic stroke, subarrachnoidal bleeding, but excluding transient ischemic attacks. CNS: central nervous system; IC:
intermediate care; ICU: intensive care unit

Since January 2005, morbidity has been prospectively recorded in all patients admitted to the Colorectal
[6]
Unit and the Department of General and Digestive Surgery at our hospital . The assessment of adverse
effects is peer-reviewed. The present study was approved by the local Institutional Ethics Committee
(CEIC: 2016-636) and complied with the criteria of the Declaration of Helsinki. The STROBE guidelines for
observational studies were followed.

Statistical analysis
SPSS version 23 was used for statistical analysis. Prospective data collection allowed analysis of the data
without the presence of missing values. The quantitative variables were described using mean values and
standard deviation if normality criteria were met; otherwise, median, interquartile range (IQR), and range
(R) were used. Categorical variables were described in absolute values and percentages.

RESULTS
During the study period, 788 patients underwent TEM in our Coloproctology Unit. Seventy-two patients
did not meet the inclusion criteria, leaving a total of 716 patients. Figure 1 shows the patients included
according to indication group.

Table 2 displays the epidemiological and preoperative variables of patients undergoing TEM. Median
age was 71 years, and 430 (60%) patients were men. Median lesion size was 4 cm. Neoadjuvant treatment
was administered in 44 (6.1%) patients. Median distance from the lower edge of the lesion to the anal
verge was 7 cm, and from the upper edge to the anal verge was 11 cm. The most frequent location was the
lateral quadrant, reported in 318 (44.4%) patients. Sessile morphology was the most common in 329 (47.1%)
patients.

As regards surgical, postoperative, and pathological variables [Table 3], 655 (91.4%) patients underwent
general anesthetic. The frequency of TEM and TEO use was similar (349 (48.7%) and 367 (51.3%),
respectively), although in recent years TEO has been more widely used. En bloc resection was possible in
658 (91.9%) patients. Median surgical time was 70 min. Peritoneal cavity perforation was recorded in 51
(7.1%) cases, without major morbidity and only one case required conversion to abdominal surgery. Vaginal
perforation was observed in 12 patients; despite repair, five recto-vaginal fistulas appeared (5/12, 41.7%).
The overall postoperative morbidity rate was 22.1% (158/716), although 98 (13.7%) complications were Cl-D