An on-site audit of the South African trial of high-dose chemotherapy for metastatic breast cancer and associated publications.

PURPOSE: The randomized study reported by Bezwoda et al of high-dose chemotherapy (HDC) for treatment of metastatic breast cancer was audited on site to verify the study results. Additional published studies were reviewed to determine whether they had been subject to the required institutional oversight. PATIENTS AND METHODS: Ninety patients were reported to have been randomized and treated on this trial. A log of the names, hospital numbers, entry dates, and regimen received had been provided by the principal investigator. A search of more than 15,000 sets of medical records available from two Johannesburg hospitals was performed to locate records for as many of these 90 patients as possible. Standard auditing techniques were used. Additional clinical trials published by Bezwoda were compared against the minutes of the University of the Witwatersrand Committee for Research on Human Subjects to verify review and approval. RESULTS: Records for only 61 of the 90 patients could be found. Of these 61, only 27 had sufficient records to verify eligibility for the trial by the published criteria. Of these 27, 18 did not meet one or more eligibility criteria. Only 25 patients appeared to have received their assigned therapy temporally associated with their enrollment date, and all but three of these 25 received HDC. The treatment details of individual patients were at great variance from the published data. Nine other trials reported by Bezwoda were not reviewed or approved by the appropriate institutional committee despite statements to the contrary in the publications. CONCLUSION: The multiple publications of this study do not report verifiable data, and nine other publications coauthored by the principal investigator contain at least one major untrue statement.

Surgical care in the isolated military hospital.

BACKGROUND: To maintain the health of service members and their families throughout the world, the Department of Defense has established several isolated military hospitals (IHs). The operational environment of IHs is such that illness and traumatic injury requiring surgical intervention is common. This study sought to examine the general and orthopedic surgical experience at an IH to determine whether surgical care could be provided in an effective and safe manner. METHODS: All patients evaluated by the general and orthopedic surgeon at Guantanamo Bay Naval Hospital from October 1, 1998, to April 1, 1999, were included in this study. The following data were retrospectively reviewed: patient demographic data, diagnosis, initial and follow-up care, medical evacuation data, operative procedures, and complications. RESULTS: There were 336 patients who presented for surgical evaluation, resulting in 660 follow-up appointments during the study period. There were 31 medical evacuations (3 emergent). The surgical services performed 122 major operative procedures. There were 58 inpatient admissions. There was 1 death, and surgical complications occurred in 2 patients, for an overall morbidity and mortality of 1.4% and 0.7%, respectively. CONCLUSION: Our data show that an IH is capable of providing surgical care, including care for traumatic injuries, in a safe manner. This is the first study that provides objective evidence that general and orthopedic surgery at an IH can be provided within the standard of care.

Pedicle fat grafts for the prevention of scar in low-back surgery. A preliminary report on the first 92 cases.

Encouraged by the results of an experimental study on dogs, the authors performed pedicle fat grafts in 92 patients. The grafts were used in the following groups of patients: following primary disc removal (37 cases); following scar removal in the multiply operated back with definite root findings (37 cases); in patients with spondylolisthesis who had had prior decompressions but developed fifth lumbar nerve root pain after lateral fusion (6 cases); in three patients with spondylolisthesis and simple decompression; in nine patients with spinal stenosis. Pedicle fat grafts were obtained from the subcutaneous layer of fat of the low back in 85 patients and from the buttocks in seven patients. The grafts were brought through openings in the fascia and muscle and were used to cover the dural sac as well as the margins of the nerve root. They were held in position by a fine suture of silk. The results after a minimum follow-up of 1 year and a maximum of 4 years have been excellent or good in 66 percent of the patients who have had lateral fusion with resultant L5 root compression, in 99 percent of patients with spondylolisthesis and decompression only, and in 66 percent of patients with spinal stenosis. The results in the other two groups compare favorably with those reported in the literature.

Long-term follow-up evaluation of a few patients with spondylolisthesis treated by excision of the loose lamina with decompression of the nerve roots without spinal fusion.

Long-term follow-up observations were recorded in 52 patients with spondylolisthesis who were treated by excision of the loose lamina with decompression of the nerve roots without spinal fusion. The longest follow-up period was 146 months (average, 71 months). Measured by the method of Taillard, the average postoperative increase in displacement in all of the patients, including children, was 5%. In patients with increasing slippage, results were satisfactory in 90% and failures in 10%, whereas 82.7% of the results were satisfactory and 17.3% were failures in the group that showed no progression. Five patients underwent long-term follow-up examinations with roentgenographic studies. Follow-up periods ranged from 17 to 32 years. The largest total displacement was 14%, while only 9% occurred in the other patients. It is obvious, even in this small series, that as the disc degenerates, forward displacement occurs; however, once the disc collapses, further displacement does not occur. The study also revealed that forward displacement does not necessarily cause symptoms. Despite the unusual appearance of recent roentgenograms, the five patients were asymptomatic and satisfied with the end results at last follow-up evaluation.

Autoamputation of the first sacral nerve roots in spondyloptosis.

To our knowledge, this is the first reported case of bilateral autoamputation of the first sacral nerve roots in a patient who has spondyloptosis. The authors think that autoamputation occurred in adolescence during a period of rapid forward displacement of the fifth lumbar vertebra on the sacrum. It is postulated that the lack of motor weakness is due to the long-standing nature of the denervation and that other adjacent nerve roots supplying the triceps surae have, over time, increased the power of those muscle fibers not supplied by the first sacral roots. This finding would encourage development of methods for early reduction and fusion in children showing marked restriction of straight leg raising (ie, tight hamstrings) to prevent rapid listhesis and fixation of the fifth lumbar vertebra to the sacrum.

Pedicle fat grafts for the prevention of scar formation after laminectomy. An experimental study in dogs.

The formation of scar tissue always follows lumbar disc surgery and usually causes no difficulty. Reoperation may be necessary because of disc reherniation or because of the scar tissue itself. Reoperation is tedious and dangerous because of the presence of scar formation. Beginning in February 1975, the authors performed laminotomies in 107 dogs in an attempt to study the possibility of prevention of scar tissue formation about the dural sac and nerve roots. Gelfoam and Gelfilm were found to increase scar formation. Micropore tape and plastics such as polyethylene, mylar, and woven and smooth silastic were tried without complete success. Free fat grafts gave better protection than other substances, but it was found that pedicle grafts of fat gave more complete prevention of scar. The living pedicle fat grafts also prevented the usual closure of the laminotomy. The technique of pedicle fat grafts has also been used with success in 36 human patients to date.

Facetectomy for the relief of intraforaminal compression of the fifth lumbar root at the collapsed lumbosacral disk.

This paper presents a long-term follow-up of 23 patients with collapsed lumbosacral disks showing evidence of fifth lumbar root compression treated by facetectomy without fusion. Fifth lumbar root compression is usually caused by protrusion of the fourth lumbar disk. If this is not present the fifth lumbar root will almost invariably be found to be impinged upon laterally in the foramen by one of several mechanisms, which are detailed in this paper. Decompression of the roots at the fifth lumbar foramen may be done by either unilateral or bilateral facetectomy depending upon whether the symptoms are unilateral or bilateral. There has been no forward displacement with unilateral facetectomy and only slight forward movement of the fifth lumbar vertebrae on the sacrum with bilateral facetectomy. There has been good relief of symptoms in most patients. Arthrodesis, as a rule, is not necessary.