Leon Morgenstern

Can Surgical Research Be Ethical

Medical history is my hobby. In a roundabout way that is how I came to revisit an old interest of mine, the ethics of surgical research. I was reading an account of an early innovative surgical procedure, the first ligation of the abdominal aorta. It was performed in 1817 by Sir Astley Cooper, the father of arterial surgery. He had previously ligated a carotid artery for aneurysm in 1805, but the aorta was quite a different matter. In dogs, he had found that ligation of the aorta was not incompatible with survival, although it left the animal with weakened lower limbs. When on April 9, 1817, a patient presented at Guy’s Hospital in London with a bleeding aneurysm in the left groin, Cooper at first recommended that the wound be treated with conservative, nonoperative measures. Two weeks later, however, the aneurysm began to bleed profusely, threatening the patient with lethal exsanguination. Cooper then decided that tying the aorta was the only solution. Though he had done it on dogs and practiced it in the autopsy room, he had never done it in humans. There is no indication that he discussed it with the patient. The operation was a brilliant technical feat for those early days in surgery. Unfortunately, the patient died 40 hours after the operation. This was long before anything resembling current ethical codes for human subject research existed. Today, we have a profusion of them. Judged by current ethical standards, was it ethical for him to try the new procedure on his patient? This was the stimulus that revived my interest in research ethics, which I had once taught. In particular, I reread the literature on the ethics of innovative surgery, a subject singularly germane to this journal. I was mildly surprised to find that the topic was well covered and thoughtfully discussed in a number of well-written articles. It was what I didn’t find there that became the basis for this article. Is surgical innovation becoming so complex and so ethically challenging today that it raises the question, “Can surgical research be ethical?” These are the topics on which I did not find an in-depth discussion.

A continuing challenge: the training of laparoscopic surgeons.

Training surgeons is an arduous and difficult task. Historically, it evolved from the loosely organized preceptorships of earlier times to the highly complex residency training systems we are familiar with today. Now we face a new set of challenges in the wake of the laparoscopic revolution, for the training of the surgeon has become more difficult and arduous then ever before. It is these challenges that will be addressed in the comments that follow. I can claim no expertise in the training of laparoscopic surgeons, for I said farewell to the operating room at the very beginning of the laparoscopic era. But I had decades of experience in training residents in open surgery, which gives me a basis for comparison between times “then” and times “now” as well as the perspective of an onlooker rather than a participant. First, it is obvious that skills in laparoscopic surgery are of a highly different nature than in open surgery. Maneuvers that were performed by fingers and hands in direct contact with tissues and organs are now performed at a considerable distance from them. The sense of touch has been virtually eliminated. Within the constraints of two-dimensional viewing, the need for hand-eye coordination is infinitely greater. Not all residents are endowed with an innate ability to develop this skill. Numerous tests and devices have been devised to assess ability and to measure progress.1-3 This imposes an awesome responsibility on mentors and teachers: namely, the obligation to weed out individuals who do not meet the skill requirements. It was different in the era of “open” surgery. As proven many times over historically, great surgeons were not necessarily great technicians. This can no longer be the case with laparoscopic surgery. Second, the major portion of the learning expeence in open surgery was obtained while the resident functioned as an assistant during the surgical procedure. This is no longer the same in laparoscopic surgery, which does not offer the same hands-on experience. The assistant has a lesser participatory role in the procedure, often limited to retraction and exposure. Because of this diminution in hands-on experience, the learning curve in laparoscopic surgery will always be steeper than with open surgery. Hospitals, professional organizations, and specialty societies have struggled with the assessment of competence in the laparoscopic surgeon, especially in advanced procedures.5,6 It is an awesome responsibility that we have not yet met satisfactorily. Third, there are other obstacles to the optimum development of the laparoscopic surgeon, some old and some new. In major nonuniversity teaching

An Unlikely Pioneer in Laparoscopy: Benjamin Henry Orndoff, MD

was part of the Department of Electrotherapeutics. Students quipped that it was good only for “bullets, bones, and kidney stones.” However, the young graduate chose it for his career in medicine. Within 10 years, in 1916, he succeeded in establishing the Department of Radiology at the Stritch School of Medicine of Loyola University, Illinois. It was the first Department of Radiology established at an American medical school. He remained chairman of that department for 48 years! What induced him, as a radiologist, to probe the secrets of the unopened abdomen with a technique he called “peritoneoscopy” is not clear. First, he began by using a pharyngoscope or a cystoscope with a lamp and lens system in animals to learn the method. Later, he used a modification of the more sophisticated instrument devised by Hans Christian Jacobeus in Sweden. He induced a pneumoperitoneum through an intraspinal needle with oxygen under local anesthesia. His penchant for radiology then took over. He fluoroscoped the abdomen to determine the relative distention of the peritoneal cavity and to locate pathological organs, which it would be desirable to avoid when the peritoneoscope is inserted. He then inserted his trocar and cannula, threading his peritoneoscope through the cannula to make his observations. Orndoff began his clinical applications of peritoneoscopy in December 1919, reporting them to the Loyola Research Society, Chicago, in 1920 and later that year to the Omaha Roentgen Society, Nebraska. He had accumulated 42 clinical cases, on the basis of which he published in his seminal article, “The Peritoneoscope in the Diagnosis of Diseases of the Abdomen.” He described his observations on patients with localized and generalized peritonitis, hemoperitoneum, ascites, ectopic pregnancy, salpingitis, ovarian tumors, and intra-abdominal neoplasms of various kinds, including carcinomas of the stomach, pancreas, and hematologic malignancies. The history of laparoscopy has been well documented in a number of recent publications. Having recently written on the role of Bertram Bernheim, the first laparoscopist in the United States, I was intrigued by the paucity of information on the second laparoscopist in the United States, one who really deserves the credit in the United States for introducing the laparoscopy akin to the technique we use today. In the usual historical accounts, he usually gets a line or 2, his name is frequently misspelled, and minimal or no credit is given for his contribution. Yet, his contribution was substantial, and the circumstances around it were unusual. The innovator whom I refer to was not a surgeon, internist, or gastroenterologist. To my surprise, he was a radiologist famed for many achievements in radiology but only for 1 memorable achievement in surgery, namely, the introduction of pneumoperitoneum and peritoneoscopy in 1920. This is the story of Benjamin Harry Orndoff, the radiologist, and how he breached the peritoneal barrier in the United States long before its meteoric rise in surgical practice later in the 20th century. Dr Orndoff was born in Pennsylvania in 1881. As a boy, he helped care for sick animals on the family farm, which may have led him later to the study of the healing arts. He graduated from Valparaiso University in Indiana with a degree in pharmacology in 1905. Medical school followed shortly thereafter, and he received his MD from the Chicago College of Medicine and Surgery, Illinois, in 1906. Radiology was still in its infancy then. In the medical school, it Surgical Innovation Volume 15 Number 1 March 2008 5-6

The Decline and Fall of the Surgical Incision

Every surgeon can remember when he made his first incision. My most vivid recollection is not of when I made my first incision, but of when I was about to make it. I was a first year surgical resident, flushed with the excitement of my first operation. It was to have been a lateral incision for a felon of the distal phalanx of the right thumb. (You can see how vividly I recall the scene, despite the passage of 6 decades!) As I was about to incise the swollen digit, my supervising attending surgeon requested that I hand him the scalpel and he then proceeded to show me how it “should be done.” I have never forgotten the moment. I have never forgiven the attending. It was to have been a rite of passage. Instead it was a usurpation of rights. But that is not the subject of this piece. What stimulated me to recall that ignominious episode at the start of my surgical career was a news item extolling the wonders of a new operation without an incision. That got me to thinking about incisions in general, most particularly about abdominal and thoracic incisions. In one generation, my own, they had devolved from the generous sweep of the scalpel from xiphoid to pubis, or from scapula to mid-axillary line, to barely discernible stab wounds for trocar insertion. Incisions have not only gotten smaller, they are in the process of disappearing altogether. That devolution is the subject of my essay. Before the advent of anesthesia, abdominal incisions were rarely elective and seldom used. The acknowledged pioneer of abdominal surgery (Ephraim McDowell, 1771-1830) did his first operation in 1809 through a left rectus incision measuring 9 inches in length for an ovarian tumor and another in 1816 through a midline incision from 2 inches above the umbilicus to an inch above the os pubis, also for an ovarian tumor. These operations were done on remarkable women with the aid of tincture of opium, clenched teeth, restraints, and remarkable courage on the part of both patient and surgeon. Both women recovered (miraculously), earning for McDowell his distinguished patrimony and worldwide acclaim. With the aid of anesthesia, introduced in the mid19th century, incisions got bigger as surgeons became better and bolder. By the latter part of the 19th century, Theodor Billroth (1829-1894) could also claim some parental rights to abdominal surgery with his celebrated gastrectomy in 1881 and other pioneering abdominal operations. Eponymic abdominal incisions followed, such as the “Kocher” for cholecystectomy, the “Kehr” for more difficult cholecystectomies, the “McBurney” for appendectomy and the “Pfannenstiel” for hysterectomy. Two World Wars and the burgeoning endemicity of violent trauma popularized the xiphoidto-pubis incision. In my surgical residency days, there was no question that the capstone of the surgical teaching on surgical incisions was “bigger is better.” An oft-quoted aphorism was that incisions healed from side-to-side and not end-to-end. No matter that patients hurt more from end-to-end than they did from side-to-side. The challenge to the established precept of bigger and bigger incisions came with the introduction in the 1980s of the mini-laparotomy. With good light, strict attention to surgical anatomy (and good luck), gallbladders could be removed through relatively miniscule incisions. This was the ultimate challenge for the surgical artisan and certainly doable, but only a minority of surgeons adopted it. For the great majority of surgeons, ample incisions still afforded the best exposure, the least margin of error, and the best insurance against catastrophic outcomes. Exploratory laparotomy lived up to its expectations when the incision was equal to the task of exposing an elusive diagnosis. As operations increased in complexity and technical difficulty, From the David Geffen School of Medicine (Emeritus, Professor of Surgery) at the University of California, Los Angeles, Los Angeles, California.

No place to hide: the ethics of disclosure.

Behind both these editorial commentaries was a litany of real or perceived inappropriate rewards given to doctors by makers of medical devices. As in previous years, the chief players were in interventional cardiology and orthopedic implants. Tens of millions of dollars were involved to “buy” influence among surgeons. Four hundred thousand dollars for just 8 days of consulting to one surgeon;

The 200th Anniversary of the First Endoscope: Philipp Bozzini (1773-1809):

700 000 to another for 9 months of consulting fees. Recreational rewards to others (cruises, resorts, sailing, fishing, etc). Not a pretty picture for the public.