The Annals of the Royal College of Surgeons of England has retracted a 2013 article by a group from Dubai and Italy after learning of serious issues with the data in the report.
The article, “Transanal haemorrhoidal dearterialisation with mucopexy versus stapler haemorrhoidopexy: a randomised trial with long term follow-up,” purportedly described a long-term telephone follow-up study of patients who had undergone the procedure. Here’s the abstract:
The present study aimed to compare the long-term results of transanal haemorrhoidal dearterialisation (THD) with mucopexy and stapler haemorrhoidopexy (SH) in treatment of grade III and IV haemorrhoids.
One hundred and twenty-four patients with grade III and IV haemorrhoids were randomised to receive THD with mucopexy (n=63) or SH (n=61). A telephone interview with a structured questionnaire was performed at a median follow-up of 42 months. The primary outcome was the occurrence of recurrent prolapse. Patients, investigators and those assessing the outcomes were blinded to group assignment.
Recurrence was present in 21 patients (16.9%). It occurred in 16 (25.4%) in the THD group and 5 (8.2%) in the SH group (p=0.021). A second surgical procedure was performed in eight patients (6.4%). Reoperation was open haemorrhoidectomy in seven cases and SH in one case. Five patients out of six in the THD group and both patients in the SH group requiring repeat surgery presented with grade IV haemorrhoids. No significant difference was found between the two groups with respect to symptom control. Patient satisfaction for the procedure was 73.0% after THD and 85.2% after SH (p=0.705). Postoperative pain, return to normal activities and complications were similar.
The recurrence rate after THD with mucopexy is significantly higher than after SH at long-term follow-up although results are similar with respect to symptom control and patient satisfaction. A definite risk of repeat surgery is present when both procedures are performed, especially for grade IV haemorrhoids.
The notice is — alas — behind a pay wall. But you can read it here:
The Annals has taken the unusual and serious step of retraction of a paper published in May 20131 because serious doubt has been cast on the reliability of the report. After publication we were informed by the Hospital Director of a hospital in Dubai named as the research site that the first author had worked there for a short time but that his employment ceased before the stated end of recruitment to the study. The paper had five authors, all based in Italy, yet the Methods section described patient recruitment only in the City Hospital, Dubai.
The hospital pointed out several discrepancies between the report that we published and their records. These included that:
• the author performed only 27 haemorrhoid operations at the hospital, yet the paper deals with a sample of 143 patients;
• the paper states that approval was granted by the Ethics Committee before research began but the records show that no approval was granted by the Ethics Committee or by the hospital management to conduct any study at the hospital;
• the report described telephone follow-up interviews with patients in 2012 although it was not standard practice to perform telephone follow-ups 40 months after operating. Furthermore, the authors did not have access to patient records from the City Hospital in 2012.
The Annals asked the authors to comment on all of these points. It transpired that approval from an Ethics Committee in Italy was obtained only after recruitment had ended. The authors have failed to provide a convincing description of how recruitment, randomisation and data collection continued after the departure of the first author and how the follow-up data were collected.
In view of the continued uncertainty about the origin and reliability of the data in this report we have withdrawn it and we have informed the relevant regulatory authorities.
- Lucarelli P Picchio M Caporossi M et al. Transanal haemorrhoidal dearterialisation with mucopexy versus stapler haemorrhoidopexy: a randomised trial with long-term follow-up Ann R Coll Surg Engl 2013 95246251.
Although the main issue with ethics committee approval here appears to be that the authors misrepresented when they obtained it, post-treatment consent has been a subject of discussion in other cases.