Brij B. Agarwal

Prospective double-blind randomized controlled study comparing heavy- and lightweight polypropylene mesh in totally extraperitoneal repair of inguinal hernia: early results

BackgroundSuccess of totally extraperitoneal (TEP) inguinal herniorrhaphy depends upon strengthening of the weakened native tissue by inflammation resulting in mesh–aponeurosis scar tissue (MAST) complex formation. The inflammatory response attributable to polypropylene (PP) content of the mesh is linked to weight of PP and pore size of the mesh. Continuation of the inflammatory process beyond MAST complex formation can entrap contiguous structures, leading to adverse outcome such as groin pain. Reduction of PP content has been shown to be beneficial in animal studies. Paucity of randomized controlled trials (RCTs) on human beings has left choice of mesh to surgeon preference or cost. We carried out a double-blind RCT comparing heavy- and lightweight PP-based meshes in TEP.Patients and methodsConsecutive, married, sexually active male candidates for bilateral TEP herniorrhaphy were enrolled without any exclusion, with ethical and informed consent protocol. Standard TEP technique was followed for day-care surgery. Heavy- and lightweight meshes were implanted in each patient, one in either groin after randomization. Surgeon and patient were blinded to side of groin and type of mesh. An independent doctor (AID) evaluated the patients for groin pain, discomfort, sexual dysfunction, and clinical recurrence. A nonmedical secretary/AID transferred prospective data for both sides of groin collected by AID to Microsoft Excel.ResultsTwenty-five bilateral TEPs implanting 25 heavy- and 25 lightweight PP meshes, one of each type in each patient, were performed from December 2005 to July 2007 without difficulty or complication. Lightweight PP mesh was associated with significantly better pain scores, patient comfort, and sexual function. There was no infection or recurrence with either type of mesh.ConclusionLightweight PP mesh is associated with significantly better outcomes in TEP inguinal herniorrhaphy as compared with heavyweight PP mesh.

Anatomical footprint for safe laparoscopic cholecystectomy without using any energy source: a modified technique

BackgroundOver the last two decades, laparoscopic cholecystectomy has become the gold standard for treating cholecystolithiasis and an index operation for evaluation and assessment of laparoscopic surgical skills. Its wider application and continuous refinement have not been accompanied by a commensurate decrease in morbidity due to biliary, vascular, or visceral injuries. Use of an energy source, especially monopolar electrosurgery, has been identified as a culprit for many of these injuries. This study assessed the feasibility of performing laparoscopic cholecystectomy safely without using any energy source by taking advantage of the avascular anatomical planes.MethodPatients attending the surgery clinic of our center who were candidates for a laparoscopic cholecystectomy were enrolled. Informed consent was obtained from each patient before the procedure. The study was approved by the Ethical Review Board of the hospital and was conducted as per GCP guidelines.ResultsBetween June 2005 and July 2006, 83 patients were enrolled. All patients underwent laparoscopic cholecystectomy without any energy source being used. There was no incidence of biliary, vascular, or visceral injury. All patients remained hemodynamically stable. There was no conversion or mortality. The hospital stay was 8–16 h. Patients were followed up by telephone for the first 48 hours and then by regulat outpatient visits until they were well.ConclusionA safe laparoscopic cholecystectomy without using any energy source can be performed by following the proper anatomical footprint.

Journey of the carbon-literate and climate-conscious endosurgeon having a head, heart, hands, and holistic sense of responsibility

And what is good … and what is not good, need weask anyone to tell us these things—PlatoAdvances in minimally invasive surgery have seducedsociety as a whole. The appeal of endosurgery is premisedupon reduced morbidity, speedier recovery and return towork. ‘Primum non Nocere’ thus seems like second natureto the endosurgeon. Endosurgeons are also at the forefrontof developing innovative therapies utilizing evolvingtechnologies. Like any other technological development inthe world, laparoscopic surgery too has a potential impacton our environment. Murmurs of this concern are dis-cernible in a recent article [1]. This is a call for us to peepdown the ‘‘ozone hole.’’ The greenhouse effect of carbondioxide (CO

Transaxillary endoscopic excision of benign breast lumps : a new technique

BackgroundBenign breast lumps affect 10% of women in their lifetimes. Despite a favorable natural history enabling surveillance as an option, surgical excision continues to be popular. Avoiding a scar on the breast is an inherent feminine desire. Because the breast is a part with a high charge in the culture, women seek to keep it away from the surgical knife. Numerous minimally invasive approaches have evolved as a result of this psychology. These leave much to be desired. Circumareolar incision at best camouflages the scar, which still is sited on the breast. This scar is subject to the same sequelae as any other breast scar. The axilla, an anatomically contiguous space, provides easy access for endoscopic breast surgery. The authors used this access to excise benign breast lumps endoscopically. This spared the breast from a scar.MethodsBetween January 2002 and March 2005, 14 women with benign breast lumps underwent surgery. Transaxillary endoscopic excision of 18 such lumps was performed.ResultsA total of 14 women with 18 benign breast lumps underwent surgery. The mean operative time per patient was 66.78 min (range, 40–110 min). No axillary injury, bleeding, technical difficulty, surgical emphysema, conversion, hematoma, or rehospitalization occurred. All the women expressed their satisfaction and happiness with the operation.ConclusionEndoscopic excision of benign breast lumps is a safe and patient-friendly procedure.

Innovations in Endosurgery-Journey into the Past of the Future: To Ride the SILS Bandwagon or Not?

Progress in surgical practice has paralleled the civilizational evolution. Surgery has progressed from being the last resort in saving life to being form and function preserver. Post-renaissance Industrial age gave an impetus to this march of surgery. The currently on going digital technological revolution has further catalysed this march. Having achieved the stabilized and acceptable clinical outcomes, the surgeon has embarked on a journey of improving patient reported outcomes (PRO). Improvement in PROs with the advent of laparoscopic surgery with the attendant emphasis on minimising invasion has led to debates about invasion being just parietal or holistic in physiological sense. There is a concern that parietal invasiveness shouldn’t be a trade-off for compromised clinical outcomes. Single Incision Laparoscopic Surgery (SILS) in its current avatar with current instrumentation seems to be an enthusiastic bandwagon rolling on with the cosmetic benefits acting as veil to hide the potential clinical concerns. History of surgical innovations is riddled with tales of vindictiveness and vicissitude. Lest the same fate befalls SILS we would do better to examine the SILS bandwagon in its current form till the emerging technologies address the current concerns.

Laparoscopic biliary tract injury prevention: zero tolerance, error free performance

Laparoscopic cholecystectomy is the gold standard procedure for initiation of a surgeon to the field of therapeutic endosurgery. It is an index operation for the training and evaluation of endoscopic surgeons. It is an index of endosurgeon’s social prestige and social perception of endoscopic surgery as well. Cholecystectomy, performed first by Carl Langenbuch in Europe and then by Justus Ohage in America, has been an index of innovations in surgical approaches as well. Piloted from the open era to the endoscopic era by Eric Muhe, laparoscopic cholecystectomy remains an index for the reporting of new endosurgical approaches, whether transgastric, transvaginal, or transumbilical. Irrespective of the approach, biliary tract injuries continue to haunt the endosurgeon even after eclipse of the learning (proficiency) curve [1]. Professional, social, and ethical costs associated with biliary tract injury have raised concerns across professional bodies such as the Society of American Gastrointestinal and Endoscopic Surgeons and the American Hepato-Pancreatic-Biliary Association, leading to introspection [1]. Patient-reported outcomes, the cornerstone of any new procedure [2], necessitated further analysis of possible contributory factors. Delineation of the proper biliary anatomy in all patients, use of Strasberg’s critical view of safety, and anatomic dissection have continued to be emphasized [1]. A reduction in the potential for cognitive error by ‘‘believing the seen and visible’’ and not trying to visualize a formed belief is important [3]. Concepts of ‘‘systems based approach’’ and ‘‘readbacks’’ have become mandatory to the practice of safe surgery [3, 4]. This error reduction model approach has proven itself in the airline, shipping and nuclear industries. The fact that injuries still are a problem is apparent by the advocacy of intraoperative cholangiography to avoid missing the injuries [1]. Biliary tract injuries remain an index of adverse outcomes in laparoscopic cholecystectomy. Technical considerations, including the necessity of energized dissection (ED) and the possible risk of instrument malfunction, have been accepted as necessary evils [1, 5]. Universal reliance on ED in laparoscopic surgery has blunted the distinction between dissection and hemostasis. This tantamounts to acceptance of collateral damage [6] despite the higher potential for thermal spread and heat absorbance in laparoscopic surgery even with the latest ED devices [7]. With evolution of laparoscopic skills, the distinction between anatomic dissection and non-ED hemostasis has been established. Now ED is not required in the index endoscopic surgery (i.e., laparoscopic cholecystectomy) [7]. However, delineation of biliary anatomy may be a concern in cases with severe and extensive inflammation. Hopes were raised by beautiful delineation of the biliary anatomy in difficult circumstances by autofluorescence of bile used in an animal model [8]. Three years of scientific pursuit since then, have demonstrated its application in human beings now [9]. Fluorescent intravenous cholangiography using easily available and safety proven indocyanine green is a definite B. B. Agarwal K. C. Mahajan Sir Ganga Ram Hospital, New Delhi 110060, India

Informed consent-'da Vinci code' for our safety in empowered patient's safety

Respect for patient safety and quality of care improvement in laparoscopic surgery drives us to better ourselves perpetually. The same concerns, however, are becoming powerful bargaining tools in the hands of politicians, lawyers, insurance companies, and business tycoons [1]. We face unhappy patients, reluctant payers, and the stick of shifting regulations, with safety and quality concerns dangled like a carrot. We need to ponder why we have allowed ourselves to be boxed in by such a situation? Society’s yardstick for our performance and hence our reward is the outcome of the operation we perform [2]. The outcomes of our operations are at times unpredictable, causing personal regret despite heart and soul put into the care [3]. Also we lack consistency in reporting outcomes, and fail to practice what is preached [4]. We have been seen as reluctant to adopt critical incident reporting systems that have been advocated much earlier [2, 5]. A systems-based approach is not only a requirement imposed on us by an informed society but also a safeguard for us when things go wrong. The practice of evidencebased medicine is a basic tenet of such systems, informed consent being the very beginning of this systematic journey. Any hiccup in this journey is a potential stick in the hands of regulators. It prompts the financial fat cows to get us sign on a dotted line, exhorting us to be content in remembering that surgery is a calling with personal satisfaction of a job well done [1]. They envy our profession, the only one that has all three ingredients of the good life: learning, earning and yearning. The article by Neary et al. [6] addresses the issue of informed consent in a basic manner, raising some very pertinent and disturbing questions that demand a response. It reminds us that ‘‘informed consent’’ is not truly informative, participative, and voluntary from the patient’s perspective, or why would a significant number of them view it as a ‘‘disclaimer’’? Why would they see it as a protective mechanism for the provider only? Why would these perceptions cut across levels of maturity and gender? And why should such a perception be at cross purposes with the ‘‘patient questionnaire’’ and ‘‘staff questionnaire’’? The last question is an answer in itself and answers the preceding questions. Differing perceptions indicate either vested interest or failure of the communication process. Either way it contradicts the spirit of informed consent. This study holds a mirror to us. Our intentions are always pure and our dealings precise. In fact, surgery is the highest adjective used for anything done precisely. Our care, knowledge, judgment, and technical capability are hallmarks of precise clinical care. Probably, we should accept in ‘letter and spirit’ that informed consent is not merely getting a patient to sign a form. We need to give credence to the perceived vulnerability and helplessness of patients and avoid any coercive moments. We need to be holistically conscious of the social, cultural, economic, and educational plurality of society and increasingly less fiduciary in our dealings. We should not use the jargon of ‘‘reasonable physician standard,’’ ‘‘reasonable patient standard,’’ or ‘‘subjective standard.’’ We should rather empathize with the patient and try to harmonize our thinking process with his or her intellectual and mental frame. We should not hypothesize much about the quantum of information being sufficient or B. B. Agarwal Sir Ganga Ram Hospital, New Delhi 110060, India

Recurrent laryngeal nerve, phonation and voice preservation—energy devices in thyroid surgery—a note of caution

Reservations [1] about energized dissection (ED) in thyroidectomies (EDIT) and ED-induced iatrogenic catastrophes in laparoscopy exhort us to forsake adventurism, with technology un-benchmarked against standards of patient safety [2]. Surgeons embody Plato’s “techne iatrike”, Aristotle’s desire for dexterity, and artist’s sensibilities, remembering the technology as a double-edged sword, giving accolade and criticism equally [2]. The advocates of EDIT, reporting higher rate of insult to recurrent laryngeal nerve (RLN), confess to essentiality of meticulous surgical technique and await prospective randomized control trails (RCT), knowledge about thyroid specific heat dispersion and heat sink engineered ED. Even RCTs cannot negate the basics of surgical precision and hemostasis [3]. A few minutes gain should not be traded off against quadrupled complications. Redundancy of assistance is made a virtue violating the team-based “systems approach”, sounding contemptuous towards training. Surgeons train in heterogeneous fiscal atmospheres with universal concerns about ethics and safety. Time advantage remains unsupported by hepatectomy experiences where the collateral damageinduced biliary sealing is a virtue, but structures around thyroid cannot be bartered as collaterals for damage. “Patient-reported outcomes” are the proper “study end points” in this era of informed patients, and “technological toy”-wielding surgeon, as altered “phonation frequency range”, and vocal flitter reported in thyroidectomies with preserved RLN indicate invisible insult during dissection. Involuntary spread of invisible energy in ED insults the precision of cold sharp dissection, something regaining respect even in laparoscopic surgery [4]. History of thyroid surgery is a study of evolution of hemostasis. Advocacy of ED for hemostasis is contemptuous for pioneers whose names live on in the hemostats that we use, i.e., Schiebervorrichtung of Fricke, Kocher, Halsted, Mayo, Crile, and Lahey. Hemostatic techniques in thyroid surgeries are an index of surgical skills. It might surprise us that the hemostatic forceps were developed to replace cautery. Even Halsted castigated Cushing (co-inventor of Bovie) by saying “The only weapon with which the unconscious patient can immediately retaliate upon the incompetent surgeon is hemorrhage”. The benchmark in hemostasis evolved despite criticism from Berry calling thyroidectomy “worse than useless” and Gross “No honest and sensible surgeon, it seems to me, would engage in it”. Invisible RLN insult from thermal spread goes undetected because only laryngeal electromyography can exclude such an insult. There are more vulnerable structures, i.e., parathyroid vasculature and the nerve of Amalita Galli Curci. ED is an environmental compromise too [4]. To submit all patients to something that has a small benefit in a small group of patients and yet has complications that are measurable in the larger group seems madness [5]. Langenbecks Arch Surg (2009) 394:911–912 DOI 10.1007/s00423-009-0504-x

The man—machine interface, a paradox of technology. Is the black box (BB) concept an angel or a demon?

Congratulations for publishing the article by Verdaasdonk et al. [1]. This is a testimony to the torch-bearer role of your August journal in advancing the progress of endoscopic surgery. Evolution of endosurgery has been aided and preceded by innovations in technologies such as endo-optics, cable connections, insufflators, energy sources, light sources [2], and recording apparatus. However, they are not immune to malfunction or malapplication and cannot replace human judgment. A good surgeon believes what he sees and not otherwise [3]. He dissects in avascular anatomical planes by sharp dissection [4] keeping the energy sources as standby only [5]. In laparoscopic cholecystectom, a range of skills can be performed without using energy sources [5], a potentially harmful yet necessary tool. Even in hernia surgery the potential harm from technology is being recognized and this is just the tip of the iceberg [6]. This scenario is alarming due to the aspersions cast upon our honesty [7], documentation [8], and politics [9]. To err is human and there is no aura to an error [10]. Adverse events may occur when least expected [11]. The chances of error increase in minimally invasive surgery due to over-reliance on technology [1]. We have been following the black box (BB) concept by recording all of our procedures with the satisfaction of being able to go back and analyze an unexpected outcome. This has given us increased confidence and peace of mind. Heightened awareness and demands from the society [12], the systems approach, and the desirability of mandatory reporting [10]mandate the adoption of the BB concept. Technology is rolling ahead like a steamroller, so it is better to be part of it, rather than be rolled over by it. Society is watching our attire [13], etiquette [14], whether we are technolgy savvy, and our communication skills [12]. We should assume this leadership [12] by voluntarily adopting the BB concept. This will be a useful tool for teaching, self-monitoring, and selfimprovement. Our demigod stature of past may not retun but surely a self-regulatory step such as the BB concept will enhance our prestige and esteem [15]. Shying away will not postpone this, but will be judged as contemptuous by the society. References

The risk of communicating TEP-related infertility risk is an opportunity and not a "Cinderella concern" any more.

Congratulations to our Editors on promoting publications aimed at improving outcomes of surgical procedures. It speaks volumes of their professional acumen as well as social responsibility. Totally extraperitoneal (TEP) inguinal herniorrhaphy has gained acceptability as a cost-effective standard-of-care procedure with all the inherent advantages of minimally invasive surgery [1]. Polypropylene (PP)based meshes have been integral to effectiveness of this procedure. Biocompatibility of PP-based meshes continues to challenge the scientific demeanor of the surgeon. Two recently published works have dwelt on this challenge [2, 3]. These articles have indicated improved biocompatibility with reduced PP content. While inflammatory response is muted, its markers are detectable even years later [3]. The persistent inflammatory response and resultant cicatrization has potential to insult the contiguous structures including vas, leading to functional obstruction and spermatozoid repression [4]. This PP-mesh-induced response to the structures of the spermatic cord [5] is discouraging in the context of reported improvement in testicular function after herniorrhaphy [6]. The anticipated improvement in testicular function attributed to vascular dynamics [6] also becomes doubtful in light of the possibility of prosthesisinduced vascular insult [7]. Irrespective of these observations there is no denying the greater likelihood of male factor infertility after inguinal herniorrhaphy as compared to the general population [8]. This concern needs our attention [9]. The issue of male factor infertility attributable to obstructive azoospermia seems difficult to investigate prospectively [9]. My personal experience of dealing with post-TEP secondary male infertility within a year or so of TEP prompted me to think about the issue dispassionately. The histopathological evidence of insult to the integrity of vas in animal studies [4] mandates a feasible approach to study it in humans. I have tried having a pre-TEP-related vas insult issues incorporated into the informed consent of my patients. This has led many patients to avoid a TEP done by me. My experience in laparoscopic cholecystectomy without energy sources [10] and endoscopic breast lumps surgeries [11] was similar. Many patients expressed doubts about my approach due to the disapproving opinion from my professional friends. I continue to explore the window of opportunity of getting my patients to agree to a pre-TEP semen analysis. This will surely help in the future to document scientifically the TEP-associated infertility risk. B. B. Agarwal Indian Medical Association, WTB, New Delhi, India