Julia Hardt

Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions.

BackgroundTrial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available.MethodsThe ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register.ResultsThe search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database.ConclusionsAlthough still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor.

A pilot single-centre randomized trial assessing the safety and efficacy of lateral pararectus abdominis compared with transrectus abdominis muscle stoma placement in patients with temporary loop ileostomies: the PATRASTOM trial.

Transrectal stoma placement is considered the standard technique for positioning a stoma. A prospective series using a novel method of lateral pararectal stoma placement recently revealed a remarkably low stoma herniation rate. A randomized trial was conducted to compare the lateral pararectal with the transrectal stoma position with regard to parastomal herniation, stoma‐related morbidity and quality of life.

Resection enterostomy versus Hartmann’s procedure for emergency colonic resections

BackgroundIf a primary anastomosis is considered too risky after emergency colon resection either a resection enterostomy or an end stoma with closure of the distal bowel (Hartmann’s procedure) is possible. This study analyzes the rate of restoration of intestinal continuity and other surgical outcomes after resection enterostomy placement versus Hartmann’s procedure for emergency colon resections.MethodsAll patients who underwent emergency colorectal resections between August 2009 and June 2014 at the University Medical Center Mannheim were reviewed in regard to therapeutic approach, rate of restoration of bowel continuity, and surgical morbidity after the primary operation and after reversal surgery.ResultsFifty-five patients in whom both studied interventions would have been technically feasible were further analyzed. The rate of revisional surgery was significantly higher in the resection enterostomy cohort after the primary operation. There were no significant differences regarding morbidity, mortality, and the rate of restoration of intestinal continuity. Overall, bowel continuity could be restored in 63% (29/46) of the surviving patients. The median time of surgery of the initial as well as of the reversal surgery was significantly longer in the Hartmann’s group. Five of 13 patients underwent protective ileostomy placement in the Hartmann’s group at the time of the reversal (vs. none in the resection enterostomy group).ConclusionsThe bowel continuity can be restored in the majority of patients after emergency colonic resection. Conclusive evidence which surgical option should be preferred when a primary anastomosis is considered too risky—Hartmann’s procedure or resection enterostomy—is still lacking.

Reply to 'Response to a pilot single centre randomized trial: the PATRASTOM trial' and 'Assessing the efficacy of lateral rectus abdominis positioned stoma (LRAPS) formation in the PATRASTOM trial'.

Dear Editor, We appreciate the constructive response of Mr Stephenson and the CIPHER study group to our PATRASTOM trial [1,2]. Some of the aspects need to be discussed and clarified. As suggested by the CIPHER group, we agree that patients should rather be randomized intra-operatively to prevent exclusion of randomized patients as this may result in bias. The PATRASTOM trial was designed accordingly. Patients were randomized intra-operatively and none of the 15 patients excluded intra-operatively had actually been randomized. In detail, 60 of 82 potentially eligible patients were randomized; 56 of these underwent the final analysis (see Methods section and Fig. 1, the CONSORT diagram) [3]. The second point refers to the method of detection of parastomal herniation, which was the primary end-point of the study. After our Cochrane Review had shown inconclusive evidence regarding our question whether the lateral pararectal approach lowers the rate of parastomal herniation compared to the transrectal standard [4], the PATRASTOM trial was designed as a pilot with the aim of assessing the incidence of the primary end-point in both intervention groups (lateral pararectal vs transrectal stoma placement). Obviously, there are several ways to diagnose parastomal hernia (PSH) but most are rather subjective and inaccurate, especially when the PSH is small. Moreover, CT scanning often suggested as the ‘gold standard’ involves application of radiation and is debatable in the setting of a benign disease within a prospective study. In contrast direct visualization of parastomal herniation during an ileostomy reversal procedure is obviously a very sensitive and simple method, which allows the detection of even subclinical hernia formation. A covering ileostomy is a commonly carried out procedure and, as most are closed within a short time after construction, this clinical model seemed ideal for a study to generate useful initial data for a later larger study. As correctly stated the rate of PSH in loop ileostomies does not necessarily correspond to the absolute rate in end stomas but it gives an impression of the magnitude of the potential difference of the two stoma techniques of lateral pararectal and transrectal stoma formation. In our study we therefore opted for the design presented in our paper as it allowed generation of randomized data in a clinically feasible setting. As Stephenson correctly points out [2], due to the short follow-up, the incidence of long-term PSH is bound to be much higher than the overall ‘subclinical’ rate of around 16% after 3 4 months as diagnosed by intra-operative visualization. As he suspects, the patients having undergone ileostomy closure after transrectal placement may possibly have a higher true herniation rate at the original stoma site for the reasons he states. We shall look into this aspect during the follow-up study. It is true that none of the quality of life questionnaires used was specifically validated for patients with a loop ileostomy, but as most of our patients were assumed to have had a rectal cancer it seemed reasonable to use health questionnaires validated for such patients. In fact two-thirds of patients did have rectal cancer. Moreover, when looking at other randomized clinical trials (RCTs) of PSH, to the best of our knowledge only one, the Scandinavian multicentre StomaConst RCT (NCT01694238) trial, actually used specifically validated questionnaires for quality of life assessment in PSH patients [5]. Other RCTs used generic health quality of life questionnaires, such as SF-36 or EQ-5D. The CIPHER (Cohort Study to Investigate the Prevention of Parastomal Herniation) study is referred to. This is a prospective cohort study on 4000 patients in the UK and will add to the already large bulk of non-randomized data on PSH. It is hoped that the study will contribute to designing a valid randomized controlled study for PSH in end stomas. This will be especially interesting in the wake of several upcoming RCTs comparing mesh reinforcement with standard stoma formation (Dutch PREVENT trial [6], the Swedish STOMAMESH trial (https://clinicaltrials.gov/ct2/ show/study/NCT00917995), the Pan-European SMART trial (http://www.isrctn.com/ISRCTN94943190) and the Stoma-Const trial (https://clinicaltrials.gov/ ct2/show/study/NCT01694238). In conclusion, the data are still conflicting on how best to prevent PSH. But well-designed studies are in