Stapled transanal rectal resection for obstructed defaecation and evidence‐based practice

BJS has recently taken a lead in promoting evidence-based practice in its series dedicated to patient safety and nowhere is this more important than in the introduction of new surgical procedures1. In the past, surgeons have been guilty of endorsing the introduction of new procedures before their rigorous assessment in terms of safety, efficacy and costeffectiveness. Objective assessment has often been overlooked because of the intrinsic appeal of new procedures, the need to be a part of a pioneering group or, worse, owing to the financial incentives from industry. These temptations must be resisted in the interests of patient safety and good clinical practice. The use and abuse of new technologies in surgery has become a hot topic and has been highlighted in colorectal surgery by Prescatori and Seow-Choen2. The recent promotion of stapled transanal rectal resection (STARR) for obstructed defaecation syndrome is a prime candidate for a new procedure being introduced before its proper evaluation. Based on the technique of stapled haemorrhoidopexy developed by Antonio Longo, STARR employs a double-stapled circumferential resection of the lower rectum together with any associated rectocele, intussusception or mucosal prolapse. The use of two Proximate PPH-01 stapling guns (Ethicon Endosurgery, Ohio, USA) adds considerably to the cost of the operation, particularly when compared with conventional suturing techniques. This may be justifiable if the results of STARR stand up to critical scrutiny, but this cannot be determined from currently available evidence. The anatomical and physiological derangements underlying obstructed defaecation syndrome are complex and poorly understood. As a consequence, a plethora of surgical techniques have been described, with no one method achieving overall superiority. None of the techniques have addressed the underlying structural abnormalities of the syndrome in quite the same way as STARR. As a consequence, STARR has caught the imagination of coloproctologists, particularly in continental Europe, fuelling its rapid implementation into clinical practice. However, the evidence to support its widespread implementation is weak, with only three series published to date3–5. Two of these involve the same institution, none includes a control group, and all report only short-term follow-up. One is struck by a sense of déjà vu when considering the introduction of STARR; the parallels with the introduction of stapled haemorrhoidectomy are obvious. The latter was greeted with enthusiasm in 2000 following the publication of two small randomized trials6,7, but soon became the focus of controversy with the reporting of unacceptably high rates of severe postoperative pain8 and incidents of life-threatening pelvic sepsis9. Only several years and many randomized trials later are the benefits of stapled haemorrhoidectomy beginning to be realized. In much the same way, two of the three STARR studies report highly encouraging results3,4, but the third has been critical, with high rates of bleeding, pain, incontinence and recurrent constipation5. Furthermore, there has already been one death reported from a stapled rectocele repair, albeit in combination with a transperineal procedure10. In the interests of good clinical practice, it is imperative that STARR is implemented in a safe and responsible manner. The difficulty comes in deciding how to achieve this given the complexity and spectrum of abnormalities associated with obstructed defaecation syndrome. One operation does not ‘fit all’ and there are many patients who are best treated by non-operative means. Evidencebased practice promotes the randomized clinical trial as the preferred method for evaluating new technologies, but to which conventional surgical technique is STARR best compared? There is no ‘gold standard’ for comparison, and no technique that incorporates the extensive rectal resection of STARR. The indications for STARR have yet to be clearly defined, and those patients who will potentially benefit are likely to be different from those who benefit from conventional methods. In such circumstances, a good randomized clinical trial is probably not achievable. How then should we proceed in a responsible and safe manner, without totally stifling the pioneering spirit? The collection of accurate data is