Multi-Port vs. Single-port Cholecystectomy

Duration of the project Patients will be recruited for this study from September 2010 until September 2012 in all participating centers. All randomized patients will be followed up (after recovery) with outpatient clinic appointments 30 and 60 days from surgery. A long-term evaluation will be done 12 months after surgery. The last 3 months will be used for photographic analysis of cosmetic results, statistical analysis and reporting of data.

Hypothesis /Aims SPA technique is a feasible approach to the peritoneal cavity. While performing laparoscopic cholecystectomy the single umbilical access has an overall morbidity comparable to multiport laparoscopy (equivalence study) while it entails a reduced skin-incision's related morbidity rate, a reduced post-operative pain and allows a better cosmetic result. Other considered parameters (operative time, conversion rate and hospital stay) are supposed to be unchanged.

Background More recently Natural Orifice Translumenal Endoscopic Surgery (NOTES) has been highlighted to the attention of lay literature and media, after first clinical reports. Concept and feasibility had been tested in animal experiments since 20041, leading to the creation of new scientific societies and committees with the declared aim to regulate research activity, through sponsorships and registers, without reaching the goal completely. After less than three years, the race for the first cholecystectomy under NOTES conditions in a human being was having its course. Since then, many authors have reported various case collections, while many others presented consistent research activity in vitro or in vivo, but it looks evident that two different branches of research were being defined2 .

The first consists in what we would call Endoscopical Access Natural Orifice Surgery (EA-NOS) which includes all procedures truly performed through natural orifices, having the goal to design new platforms for surgery to be brought within the human body to recreate surgical conditions under safety. The evident difficulties to obtain such an environment with guaranteed ease of use, safety and efficacy, reduced to a mere research activity the interest in this field, with few clinical applications described consisting of hybrid procedures, i.e. procedures which were performed basically under laparoscopic conditions with the help of flexible instruments inserted through natural orifices. In fact, a recent large metanalysis of NOTES literature3 focusing on various surgical intra-abdominal procedures, all ascribable to EA-NOS, concluded that no human studies were found satisfactory for the inclusion criteria, for scarce disposable evidence, minor safety and efficacy compared to laparotomic and laparoscopic alternatives. The recommendation that human procedures should first pass through hybrid NOTES surgery, under strict guidelines, and in apposite controlled registers was later supported, as known, by the revision of NOSCAR "white paper" 4 . In fact, it is out of discussion that there is a need for a worldwide register, a standardization of the nomenclature, safety data to be used by ethical committees in order to authorize human trials, and implementation of the interface between medical societies, industry and regulatory offices. In this field, on behalf of the EURONOTES Foundation, we have promoted an european registry of NOTES procedures (www.euronotes.world.it) which preliminary results are now awaited.

The cooling of enthusiasm related to EA-NOS procedures has naturally forced surgeons to concentrate on techniques which could be more easily reproduced in clinical environments. This brought the interest towards what we would call Surgical Access Natural Orifice Surgery (SA-NOS)2 . In fact, an analysis of the literature would unveil that the vast majority of human studies can be ascribed to SA-NOS. A wider vision of what can be considered a SA-NOS approach, includes in this group not only transvaginal, thoroughly described in literature, but also trans-umbilical surgery. Although both approaches have the advantage of not being burdened by problems related to endoscopic defect's closure in terms of infection, safety, consistent technological research and time-consumption, there is no discussion that trans-umbilical techniques encountered more appreciation among surgeons. We have observed a rapid clinical diffusion driven by a technology development supported by all the different major surgical companies. Thus, it has to be said that single-port laparoscopic surgery is nothing new. It was 1992 when Marco Pelosi first described a laparoscopic appendectomy using a single umbilical puncture5 . Even multi-port single-incision trans-umbilical laparoscopic cholecystectomy was first described by Giuseppe Navarra already in 19977 . Despite this, interest towards single-port surgery grew-up only very recently. This might be on one side explained with the better establishment of laparoscopic techniques and skills over the years, but rises doubts about a possible industry driven interest.