5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Anastomotic leakage was reported in 5% (2/37) of patients in the transanal total mesorectal excision (TaTME) group and in 11% (4/37) of patients in the laparoscopic total mesorectal excision (TME) group in a non‑randomised comparative study of 74 patients (p=0.39; no further details provided). Anastomotic leakage was reported in 5% (3/56) of patients in a case series of 56 patients with low rectal cancer treated by TaTME; no reoperation was needed. Anastomotic leakage was reported in 1 patient in a case series of 20 patients treated by a combined transanal and laparoscopic approach; the patient needed a further procedure to remove the coloanal anastomosis and construct a permanent end colostomy. This anastomotic leakage was secondary to ischaemia, most likely secondary to disruption of the blood supply to the proximal (descending) colon.

5.2 Colocutaneous fistula was reported in 1 patient in a case series of 12 patients with benign or malignant disease treated by transanal endoscopic microsurgery proctectomy; the fistula was successfully treated by resection and creation of an ileostomy.

5.3 Asymptomatic anastomotic strictures noted on physical examination were reported in 20% (4/20) of patients in the case series of 20 patients; they were treated by manual dilatation.

5.4 Urethral injury was reported in 7% (2/30) of patients in a case series of 30 patients (1 urethral injury was caused by a difficult dissection of a large anterior tumour and the other by the presence of a concurrent prostatic carcinoma). Both were treated endoscopically with no subsequent complications (no further details provided).

5.5 Acute renal failure was reported in 1 patient in the case series of 20 patients (no further details provided).

5.6 Acute urinary retention was reported in 3% (1/37) of patients in the TaTME group and in 11% (4/37) of patients in the laparoscopic TME group in the non‑randomised comparative study of 74 patients (p=0.16; no further details provided). Transient urinary disorders were reported in 9% (5/56) of patients in the case series of 56 patients; all patients were treated by temporary urethral catheterisation. After 3 months, all patients reported normal urinary function.

5.7 Severe faecal incontinence after intersphincteric resection, needing a colostomy, was reported in 6% (3/52) of patients in the case series of 56 patients with low rectal cancer. Incontinence for liquid stools was reported in 15% of patients and for gas in 35% of patients, in the case series of 30 patients at 12 months after stoma closure (number of patients not reported).

Pelvic fluid collections were reported in 3% (1/37) of patients in the TaTME group and in 13% (5/37) of patients in the laparoscopic TME group in the non‑randomised comparative study of 74 patients (p=0.08). The patient in the TaTME group was readmitted with fever: abdominal CT scans demonstrated the presence of fluid collections without gas. The patient was successfully treated with antibiotics.

Pelvic abscess was reported in 20% (4/20) of patients in the case series of 20 patients.

Sepsis within 30 days after the procedure was reported in 10% (3/30) of patients (2 had peritonitis and 1 had septic shock) in the case series of 30 patients. Peritonitis in 1 patient was secondary to a minor ileal wound, without a direct link with the procedure. The patient with septic shock had comorbidities including a lymphoma associated with chronic renal failure and diabetes and needed critical care (no further details provided).

5.8 Delayed healing of the perineal wound was reported in 33% (4/12) of patients in the case series of 12 patients and 50% (2/4) of these patients needed drainage of a perineal wound infection.

5.9 Ileus was reported in 11% (4/37) of patients in the TaTME group and in 5% (2/37) of patients in the laparoscopic TME group in the non‑randomised comparative study of 74 patients (p=0.39). Bowel obstruction was reported in 7% (2/30) of patients in the case series of 30 patients; both patients recovered after medical treatment.

5.10 Impotence was reported in 11% (2/18) of the 18 sexually active male patients in the case series of 56 patients.

5.11 Blood transfusion after surgery was needed in 4% (2/56) of patients in the case series of 56 patients.

5.12 Incarcerated parastomal hernia was reported in 1 patient in the case series of 12 patients.

5.13 Reoperation rate within 30 days after the procedure was the same in the TaTME group and in the laparoscopic TME group (8% [3/37] of patients; p=0.97) in the non‑randomised comparative study of 74 patients (no further details provided).

5.14 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: bleeding from the pelvic sidewall, pelvic haematoma, dissection in the incorrect plane into the pelvic sidewall and ascites. They considered that the following were theoretical adverse events: damage to specimens, poor cancer outcomes from increased local or distant recurrence and bowel dysfunction.

  • National Institute for Health and Care Excellence (NICE)