5 Timeline for use of taTME

TaTME is mentioned for the first time in the National Action Programme with Guidelines for Diagnostics, Treatment and Follow-up of Colorectal Cancer (5th edition), which is published by the Norwegian Directorate of Health, with the following wording in chapter  9.1.5 Laparoscopic transanal access:
“The technique is in the development phase and although there are good results from individual centres, a systematic review in 2015 concludes that the oncological safety has not yet been adequately documented. The method should therefore be used within the framework of prospective clinical trials, with sound information for participating patients, to provide greater knowledge of outcomes.” (23)

Oncosurgical spring meeting under the auspices of the Norwegian Gastro Intestinal Cancer Group (NGICG) –
taTME results from two hospitals and notices of concern from the professional community at the Radium Hospital are presented.
 

Autumn surgical meeting under the auspices of the Norwegian Association for Gastroenterological Surgery (NFGK) – preliminary results that included just over 100 patients were presented.  Contributions from gastrointestinal surgeons at two hospitals were presented concerning recurrences after taTME for five and two patients, respectively. The method is discussed. The professional community decides to suspend the use of taTME in Norway, and NGICG is thereafter notified. There is agreement at the meeting to conduct a scientific audit of all taTME procedures that have been carried out in Norway. The agreement to suspend use of the method in Norway must be communicated internationally as quickly as possible.

14.01.19: Letters from NGICG-CR are sent to the medical directors of the regional health authorities to notify them about concerns regarding elevated complication and recurrence rates after taTME (Appendix 3). As a consequence, NGICG-CR discourages the use of taTME in the surgical treatment of rectal cancer in Norway until the following measures are established:

"a national programme for systematic instruction and training of surgeons in this technique. A national prospective study that includes all of the patients to be treated using this technique."

24.01.-25.01.19: The 9th  Ahus Colorectal Symposium is held. For the first time, results are posted publicly, including to the international community. The symposium has participants from the USA and Europe.
The preliminary results of the autumn surgical meeting are presented once again, but with updated data: nine patients with recurrences are known at this point. In addition, the special types of local recurrences observed are noted.

The Norwegian results are commented on in a “Letter to The Editor” by Americans Gachabayov et al. in the international journal Updates in Surgery. (24).
 

NGICG-CR is encouraged by the medical directors of the regional health authorities to notify the method to the National System for Managed Introduction of New Health Technologies (New Methods).

National Action Programme with Guidelines for Diagnostics, Treatment and Follow-up of Colorectal Cancer, 6th edition, is published with a minor text change from the 5th edition (the change is marked by NHIB in bold). In Chapter 9.1.5 Combined laparoscopic and transanal access, the following is stated:
“The technique is in the development phase and although there are good results from an international registry, the introduction of the technique requires structured training and randomised trials. The method should therefore be used within the framework of prospective clinical trials, with sound information for participating patients, in order to gain greater knowledge of outcomes.” (26)

It should be noted that the chapter on laparoscopic rectal surgery, Chapter 9.1.4, is expanded with a concern: “It gives grounds for concern, however, that recent studies show uncertainty regarding the oncological quality of the surgical preparation by laparoscopic access. Even though the laparoscopic technique for rectal cancer is increasingly gaining acceptance, it is important to impose requirements for training and quality assurance of the procedure. The individual hospital performing this type of intervention therefore has a special responsibility for itself documenting competence, safety and results.”

However, when the 6th edition of the National Action Programme with Guidelines for Diagnostics, Treatment and Follow-up of Colorectal Cancer is published, the taTME method has already been suspended in Norway. 

TaTME is notified by the regional medical directors themselves to the Ordering Forum, as they consider the method to be technically demanding with a considerable training need on any introduction. The Norwegian Institute of Public Health (FHI) is commissioned to conduct a literature search to identify available documentation of the method.

Media reports that Norwegian Health Minister Bent Høie is not satisfied with the information the hospitals have provided to the 157 patients who underwent taTME surgery. The Minister requires the regional health authorities to issue more detailed patient information (27).

July 2019

The interregional medical directors meeting makes the following decision based on FHI’s documentation assessment of taTME:
“Transanal total mesorectal excision (taTME) may not be introduced. The documentation is deficient. If the method is required to be assessed once again, a new order must be submitted to the National System for Managed Introduction of New Health Technologies (New Methods).” (31).