Some patients with rectal cancer may have become ill along the way because they participated in the research project instead of having surgery.
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It writes writes Aftenposten.
In the case, they refer to a column written by Hans Wasmuth, who was the initiator of the study published on kirurgen.no. There he writes that many patients have probably been exposed to unnecessary health risks, in that they were not operated on like others.
The so-called Norwait study involved that up to a hundred patients should be mapped to see if there was enough radiation for cancer patients who have the least dangerous tumors, to avoid unnecessary operations. It had strict safety requirements, including that endoscopic images (images of the rectum) be taken of the patients who were included.
But then it turned out after two and a half years that one of the hospitals had not taken such pictures of all the patients, according to Wasmuth. In the article, he writes that it turned out that this hospital had unexpectedly many patients who had developed the spread or recurrence of cancer, and that the hospital had included more patients in the study than the other hospitals.
– Very sorry
According to Aftenposten, this is Haukeland Hospital. The newspaper writes that the head of the Department of Gastrosurgery at the hospital, Bjørn Nedrebø, confirms what Wasmuth is addressing.
He says the equipment for taking pictures did not work well enough, and that the hospital switched to letting two doctors examine the patients to assess who should be included in the study.
– We are very sorry. We should have withdrawn from the study when we realized that we did not have good enough pictures, he says to Aftenposten.
– The doctors here thought they followed the protocol of who should be included. We believe there has been a professional disagreement about the interpretation here. It is clearly striking that we have included so many more than other hospitals, he says.
10 patients were spread to other organs – something Nedrebø says is more than expected, although some may also develop spread after surgery. They had 31 patients.
– Some of these patients could have been operated on instead of participating in the wait-and-see survey. And then they might not have spread, he says.
In the article, Wasmuth also criticizes that the incidents were not reported to the supervisory authorities immediately, in November 2020. He also writes that research managers at most study hospitals have not been given sufficient information about what happened.
The professional council in the project manager for the study, the Norwegian Gastrointestinal Cancer Group (NGICG-CR), and the Cancer Registry have joined a response to the chronicle.
The Cancer Registry: Examined
NGICG-CR writes in its response that the professional council decided to stop the study in November 2020, and to initiate a monitoring of the study inclusion. The latter was postponed due to the covid situation.
“There is an ongoing investigation in the steering group and in the two health trusts, and it will therefore not be appropriate to comment on the matter further now,” they write.
The Cancer Registry writes that the study is organized as a multi-center study, where they are one of eight institutions responsible for research – in this study they have not been responsible for analyzes of the data, they write.
They point out that the study has been completed, and that the study inclusion must be reviewed.
“The investigation group has reviewed inclusion practice at seven of the study places, and will complete a report that will be presented and processed this autumn,” they write.
“We believe the professional council, project manager and the cancer register have taken the right and necessary steps in this study, and we do not recognize ourselves in the claim that there has been a long-running tug-of-war over the necessity of an impartial review as the case is presented.”
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