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Biomedical subjects

M Rothmund

Publications and source records attributed to M Rothmund.

At least 37 records · Page 2Linked to original sources
PubMed2004

[Diagnosis and surgical treatment of insulinoma--experiences in 40 cases].

BACKGROUND AND OBJECTIVE: Most insulinomas are solitary, benign and functional neuroendocrine pancreatic tumors which give rise to manifold symptoms. Their preoperative localization is often unclear, but the cure rate after their excision is very high. It was the aim of this study to analyse and evaluate our group of patients with regard to preoperative tumor localization and overall surgical results. METHODS: Data were collected as part of prospective observations and retrospective evaluation of all patients treated for insulinoma between 1987 and 2003 at the department of visceral- thoracic- and vascular surgery at the Philipps University of Marburg. In all of them the diagnosis had been confirmed by a fasting test. RESULTS: 40 patients with an insulinoma (22 females, 18 males; average age 52 years [range 12-87 years]) had been operated. The sensitivity of preoperative localization was 65% for endoscopic ultrasound, 33% for ultrasound, 33% for computed tomography, 15% for magnetic resonance imaging and 0% for somatostatin-receptor scintigraphy. But all insulinomas were identified intraoperatively by pancreas dissection and ultrasound (IOUS). 38 patients were completely cured by excision of the tumor. CONCLUSION: After positive biochemical and fasting tests and exclusion of diffuse abdominal metastases by transabdominal ultrasound, all patients should without further preoperative investigations undergo surgical excision of the insulinoma after bidigital palpation of the pancreas and IOUS. But if laparoscopic excision is planned, endoscopic ultrasound should be undertaken preoperatively.

Adolescent↗
PubMed2004

[Lateral, partial sphincter myotomy as therapy of chronic anal fissue. Long-term outcome of an epidemiological cohort study].

AIM: We observed a relatively high rate of severe forms of anal incontinence in patients who had undergone lateral, partial, internal, open sphincterotomy for chronic fissure in ano years ago in our clinic. An explicit investigation of pre- and postoperative data for a representative patient group was undertaken to find out whether this incidental finding proved to be meaningful. PATIENTS AND METHODS: The perioperative data from 523 patients who underwent sphincterotomy (Parks) between 1986 and 1997 were analyzed by uni- and multivariate analysis. RESULTS: Of 209 patients included in the study, 94.7% could be considered healed after operation. Up until the 12th postoperative week, 14.8% of patients were incontinent in stage I and II (Parks). This increased up to 21% at the time of follow-up, mainly in stage II and III, which significantly differed from a healthy control group. CONCLUSION: Lateral sphincterotomy leads in most cases to quick healing of the chronic fissure in ano with a low recurrence rate. The added effect of degenerative changes was observed to be linked, however, with a higher long-term rate of anal incontinence.

Adult↗
PubMed2004

[Multiple endocrine neoplasia type 1. Surgical therapy of primary hyperparathyroidism].

Primary hyperparathyroidism (pHPT) occurs in about 90% of patients with multiple endocrine neoplasia type 1 (MEN1). In contrast to sporadic pHPT, multiple gland disease is most common in MEN1. The appropriate surgical approach is still controversial. The aim of this study was to analyze the results of surgical therapy of pHPT in patients with genetically confirmed MEN1. In an observational study, preoperative data, operative procedures, long-term results, and a possible genotype-phenotype correlation were analyzed in patients with pHPT and genetically confirmed MEN1. According to our results, tPTX+T (total parathyroidectomy+thymectomy+autotransplantation) seems to be a more favorable surgical approach in patients with MEN1 pHPT than sDE (selective gland exstirpation) and stPTX (subtotal parathyroidectromy) without cervical thymectomy, because recurrences or persistence of the disease are rare. A prospective randomized trial is needed to compare stPTX including cervical thymectomy vs tPTX+T. A genotype-phenotype correlation could not be identified.

Chi-Square Distribution↗
PubMed2004

Medical and surgical treatment for secondary and tertiary hyperparathyroidism.

Prevention and treatment of secondary hyperparathyroidism (SHPT) in patients on chronic maintenance hemodialysis and of tertiary hyperparathyroidism (THPT) in patients after kidney transplantation is a challenge for the nephrologist and for the surgeon. Indication and results of medical and surgical therapy for SHPT and THPT have remained under discussion during the last decades. This review resumes the current medical and surgical strategies for patients with SHPT and THPT.

Bone and Bones↗
PubMed2003

[Neuroendocrine tumors of the gastrointestinal tract (NETGI) and second primary malignancies--which is dominant?].

INTRODUCTION: 13-46% of all patients with a neuroendocrine tumor of the gastrointestinal tract (NETGI, "Carcinoid") develop a carcinoma. The goal of our study was to find out the frequency of other malignancies in our patients with an NETGI and to discover which of the tumors was decisive for the clinical course. PATIENTS AND METHODS: We documented the clinical findings in 55 patients with an NETGI who underwent surgery in our hospital, noted the occurrence of other malignancies and recorded a current follow-up. RESULTS: 13 of 55 patients (24%) had an additional carcinoma after a median follow-up of 53 months. In 11 of the 13 patients the NETGI was identified accidentally. None of them had developed the carcinoma after the NETGI. CONCLUSION: In most of our patients (11 out of 13) the carcinoma was clinically predominant and discovered before the NETGI. Thus, a special follow-up looking for a carcinoma is probably not mandatory after the diagnosis of an NETGI.

Carcinoid Tumor↗
PubMed2003

Checking for interviewer bias in outcome assessment: a method for strengthening the design of prospective, randomised trials in surgery.

BACKGROUND: Blind, randomised trials are conceived as the gold standard in clinical research, but this ideal, in its strict sense, can rarely be achieved in surgical settings. One way to strengthen the study design is to check for observer bias in the assessment and evaluation of surgical outcome. METHOD: In a randomised, prospective trial comparing nasogastric versus gastrostomy tubes the primary endpoint was the subjective inconvenience induced by the tube system and was assessed in the context of a standardised face-to-face interview. These interviews were tape-recorded on a pocket memo. Two independent raters listened to these interviews and judged--on the basis of how the interviewer formulated the questions--which treatment arm they thought the patients were assigned to and how confident they were in their judgement. RESULTS: The overall proportion of correct judgements was 50.5% for rater 1 and 53.2% for rater 2. In other words, both judgement performances were not greater than chance. Nevertheless, the raters' confidence in their judgements increased significantly ( P<0.05) in the course of the rating procedure, whereas the actual proportion of correct judgements did not. There was no overlap between the two raters [kappa = 0.022, not significant (NS)] and between actual group assignment and both raters' judgements (kappa = 0.012, NS and kappa = 0.110, NS). CONCLUSION: The two independent raters were not able to detect systematic variations in the interviewing style that were contingent on treatment arm assignment. This gives further credence to the results of the randomised trial showing greater patient-reported discomfort and inconvenience with the nasogastric tube than with the gastrostomy tube. The present report describes a feasible method to monitor subtle biases that may occur in trial settings. This helps to strengthen the design of randomised clinical trials in surgery.

Feasibility Studies↗
PubMed2003

Prevalence of multiple endocrine neoplasia type 1 in young patients with apparently sporadic primary hyperparathyroidism or pancreaticoduodenal endocrine tumours.

BACKGROUND: The appropriate treatment for a sporadic endocrine tumour may be different from those that present as part of the multiple endocrine neoplasia type 1 (MEN1) syndrome. As primary hyperparathyroidism (pHPT) and pancreaticoduodenal endocrine tumours (PETs) are the most common organ manifestations of MEN1, the prevalence of germline mutations in the MEN1 gene was determined in young patients with apparently sporadic pHPT or PETs. METHODS: Eighteen of 705 patients with pHPT and 11 of 93 patients with PETs operated on between 1987 and 2001 had no family history of MEN1, only one organ manifestation and were aged 40 years or less at the time of diagnosis. Fifteen patients with pHPT and eight with PETs agreed to MEN1 gene mutation analysis, which was performed by single-strand conformational variant analysis and direct DNA sequencing. RESULTS: Two of 15 patients (13.3 (95 per cent confidence interval (c.i.) 1.6 to 40.4) per cent) with apparently sporadic pHPT had a MEN1 germline mutation. Both mutations were found in patients with pHPT due to multiglandular disease, whereas the remaining 13 patients had a solitary adenoma. None of the eight patients with PETs carried a MEN1 germline mutation. CONCLUSION: Sporadic pHPT due to multiglandular disease in patients younger than 40 years may represent the first organ manifestation of MEN1 despite a negative family history.

Adolescent↗
PubMed2002

[Information deficits and hesitant acceptance of combined pancreas-kidney transplantation in Germany. A survey at German dialysis centers].

BACKGROUND AND OBJECTIVE: The pancreas kidney transplantation (PKTx) currently is the only treatment for cure for patients with diabetes mellitus Type 1. Despite the availability of organs and the need for therapy the PKTx rate is much lower in Germany than it is in the United States. Is this attributable to an information gap?. MATERIAL AND METHODS: A questionnaire contrasting 16 statements pro and con PKTx was sent to 960 dialysis centres in Germany. RESULTS: 397 out of 960 questionnaires were returned, resulting in an response rate of 41.4 %. Regional representation was established. The central argument against combined PKTx was an assumed lack of organs (89 %). Other con-arguments were assuming a long waiting list (60 %), lack of qualified transplantation centres (40 %) and poor long-time transplant function (38 %). The most important moderator variable of the distribution of correct/incorrect answers was the direct contact to a cooperating transplant centre. Respondents with direct contact (n = 230) were significantly (p < 0.05 to < 0.001) more likely to hold correct answers with respect to 14 out of 16 single PKTx-related statements. The size of the dialysis centre as determined by the number of patients treated did not alter the distribution of correct/incorrect answers. CONCLUSION: The majority of nephrologists treating patients with Type 1 diabetes underestimate the potential of PKTx. More efforts to increase information are necessary.

Attitude of Health Personnel↗
PubMed2002

[Function and responsibility of an interdisciplinary tumor center. Need for a "cancer center" for multimodal therapy concepts].

BACKGROUND AND OBJECTIVE: Cancer will be the leading cause of death in industrialized countries within the next few years. A successful treatment represents a great challenge within the next years and requires multimodality treatment approaches. An multidisciplinary tumour center is essential for coordination and communication between different departments and institutions and is important to maintain standards in diagnostic and therapeutic procedures. METHODS: Two years ago, a cancer center was founded in Marburg. The central facility of its work is a twice weekly tumour conference, where patients requiring multimodality treatment approaches are presented and treatment procedures are fixed and documented. Furthermore, guidelines for diagnosis and treatment of the various cancer diseases will be established and the transfer of clinical and experimental research to the actual patient treatment is intended. RESULTS: A total of 407 patients were discussed within the first year. Leading cancer entities were lung cancer, colorectal cancer and tumours of the upper GI-tract. The tumour conference has improved the communication between all involved disciplines. The process of standardisation of diagnostic and therapeutic procedures is ongoing. The next step will be the documentation of the further follow up of all patients discussed in the tumour conference. CONCLUSIONS: In the communication between all disciplines involved in cancer patient care, success, be it a survival benefit or an improvement in quality of life, is most likely. All the described tasks are best organized within a cancer center.

Adolescent↗
PubMed2002

[How do general surgery patients experience the intensive care unit? Results of a prospective observational study].

INTRODUCTION: Subjective experiences of patients during their stay in the intensive care unit (ICU) have so far rarely been described. The aim of this study was to analyze the experiences of patients during their stay in the ICU. METHODS: In a prospective study, 100 general surgical ICU patients were recorded consecutively. A questionnaire that covered a broad range of possible ICU experiences was handed out to patients shortly following their stay in ICU. At the same time, a questionnaire was given to the personnel of the ICU to investigate how well nurses and doctors were able to adopt the patients' perspectives of the ICU experience. RESULTS: Concerning the physical symptoms, insomnia was to the fore (67% of patients). Despite pain medication, 25% of patients reported severe pain. The main psychological symptom was a feeling of helplessness (29% of patients). As a general cause for concern, 48% of patients complained about limited mobility. The patients were critical of the presence of severely ill patients. The standards of nursing and medical attention, however, were judged very positively. The evaluation of the staff differed from the patients' experiences in many respects; the clearest differences concerned the items of pain, sleeping disorders and the observance of privacy. CONCLUSIONS: The study results led to several practical consequences in the quality of management procedure (e.g., the introduction of a thorough night's rest at the ICU, optimized information for patients). Additionally, we initiated further studies concerning the quality of life of ICU patients.

Adult↗
PubMed2002

Quality of life profile: from measurement to clinical application.

Quality of life (QoL) can be assessed in an accurate, valid and reliable way by means of standardized QoL questionnaires and is an important endpoint in clinical trials today. The aim of this study is to implement quality of life as a diagnostic tool for problem-oriented follow-up care of cancer patients. This is done in the framework of an intervention study in the area of regional health care research using qualitative analysis and the methodological concept of barrier analysis. We developed the diagnostic tool by generating individual, graphic QoL profiles based on patients' responses to the EORTC QLQ-C30 and the corresponding disease-specific modules BR23 for breast cancer and CR38 for rectal cancer. The clinical application is investigated by assessing physicians' responses. The QoL profile is judged as a useful diagnostic tool by all participating physicians. It enables physicians to assess the QoL of the patient and incorporate the knowledge they gain in their daily practice. Especially in breast cancer follow-up care QoL profiles give added value to both patients and doctors. The next implementation steps have to extend the concept of QoL to larger groups of patients and physicians by overcoming the restraining factors as identified in the barrier analysis.

Journal Article↗
PubMed2002

Familial ACTH-independent Cushing's syndrome with bilateral macronodular adrenal hyperplasia clinically affecting only female family members.

Primary adrenal hyperplasia, which may occur as a familial disorder, is a rare cause of ACTH-independent Cushing's syndrome. In most of these cases the underlying pathology is primary adrenocortical micronodular dysplasia. Very few cases of familial Cushing's syndrome due to primary macronodular adrenal hyperplasia have been described. We report a family with seven affected family members. The pedigree indicates an autosomal dominantly inherited disorder. Interestingly only female family members developed the clinically apparent syndrome. The only available obligatory male gene carrier failed to adequately suppress his plasma cortisol level on overnight dexamethasone suppression test. His adrenal glands showed nodular enlargement on abdominal computed tomographic imaging. Screening of the MEN 1 gene and genetic analysis of the hot spot regions of the GNAS 1 (codons 201 and 227) and GNAI 2 (codons 179 and 205) genes did not show any mutations in the constitutional DNA or the adrenal tissue DNA of the index patient. In conclusion, this family is the largest kindred reported in the literature with ACTH-independent Cushing's syndrome due to autosomal dominant inherited macronodular adrenocortical hyperplasia. Four currently alive and affected family members in two generations and further careful observation of the yet unaffected members of the third available generation might offer the opportunity to identify the still unknown gene defect in the future.

Adrenal Hyperplasia, Congenital↗
PubMed2001

Nasogastric tube versus gastrostomy tube for gastric decompression in abdominal surgery: a prospective, randomized trial comparing patients' tube-related inconvenience.

BACKGROUND: Perioperative decompression of the stomach is still a common procedure and can be achieved using either nasogastric tubes (NTs) or gastrostomy tubes (GTs). While both procedures appear to be equally effective, some authors believe that NTs are less convenient for patients than GTs. However, to date, no reliable prospective data are available on this issue. METHODS: We conducted a prospective, randomized trial comparing NTs versus GTs with a total of 110 patients undergoing elective colon surgery. The primary outcome measure was the patient's tube-related inconvenience and pain, assessed in a standardized interview on day 2 after surgery and quantified by means of a visual-analog scale (VAS). A questionnaire including the EORTC QLQ-C30 and additional items regarding retrospective tube-related judgements was administered on the day of discharge and 4 weeks after discharge. Secondary endpoints were the therapy-related morbidity and general complications. RESULTS: When patients were asked which of their drainage tubes (all patients had three or four drainage tubes, such as decompression drains, urinary drains, central venous line) was most inconvenient, 43% (CI 33-53%) in the NT group reported that the NT was most inconvenient, while only 4% (CI 1-10%) of the GT patients judged the GT most inconvenient ( P<0.001, Chi(2) test). This effect was also found in VAS ratings of inconvenience and discomfort ( P<0.01). Also postoperatively (p.o.), NT patients evidenced less preference for their tube system (day 2 p.o.: 71%, CI 61-80%; 4 weeks p.o.: 66%, CI 56-75%) than did GT patients (day 2 p.o.: 94%, CI 88-98%; 4 weeks p.o.: 91% CI 84-96%); again, these differences were statistically significant ( P<0.02; Chi(2) test). No differences between groups emerged regarding global quality of life or conventional clinical outcomes. CONCLUSION: This prospective randomized trial supports the clinical observation that NT causes more subjective inconvenience than GT. In cases when a prolonged postoperative ileus is expected, decisions for a prophylactic decompressing tube system have to weigh up the possibilities of different averse clinical as well as subjective outcomes. It is then preferable to include patients' preferences in the individual decision making process (shared-decision making).

Aged↗
PubMed2001

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part one: rationale and hypothesis.

GENERAL DESIGN: Presentation of a novel study protocol to evalue the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). The rationale and hypothesis are presented in this part of the protocol of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: Part one of this protocol describes the concepts of three major sections of the study: Definition of optimum and sub-optimal recovery after operation. Recovery, as an outcome, is not a simple univariate endpoint, but a complex construction of mechanistic variables (i. e. death, complications and health status assessed by the surgeon), quality of life expressed by the patient, and finally a weighted outcome judgement by both the patient and the surgeon (true endpoint). Its conventional early assessment within 14-28 days is artificial: longer periods (such as 6 months) are needed for the patient to state: "I am now as well as I was before". Identification of suitable target patients: the use of biological response modifiers (immune modulators) in addition to traditional prophylaxes (i. e. antibiotics, heparin, volume substitutes) may improve postoperative outcome in appropriate selected patients with reduced host defence and increased immunological stress response, but these have to be defined. Patients classified as ASA 3 and 4 (American Society for Anaesthesiologists) and with colorectal cancer will be studied to prove this hypothesis. Choice of biological response modifier: Filgrastim has been chosen as an example of a biological response modifier because it was effective in a new study type, clinic-modelling randomised trials in rodents, and has shown promise in some clinical trials for indications other than preoperative prophylaxis. It has also enhanced host defence and has been anti-inflammatory in basic research. CONCLUSION: The following hypothesis will be tested in patients with operations for colorectal cancer and increased preoperative risk (ASA 3 and 4): is the outcome as evaluated by the hermeneutic endpoint (quality of life expressed by the patient) and mechanistic endpoints (mortality rate, complication rate, relative hospital stay, assessed by the doctor) improved in the group receiving filgrastim prophylaxis in comparison with the placebo group? Quality of life will be the first primary endpoint in the hierarchical, statistical testing of confirmatory analysis.

Bacterial Infections↗
PubMed2001

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. CONCLUSION: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Clinical Protocols↗
PubMed2001

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part three: individual patient, complication algorithm and quality manage.

GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). A randomised, placebo controlled, double-blinded, single-centre study is performed at an University Hospital (n = 40 patients for each group). This part presents the course of the individual patient and a complication algorithm for the management of anastomotic leakage and quality management. OBJECTIVE: In part three of the protocol, the three major sections include: The course of the individual patient using a comprehensive graphic display, including the perioperative period, hospital stay and post discharge outcome. A center based clinical practice guideline for the management of the most important postoperative complication--anastomotic leakage--including evidence based support for each step of the algorithm. Data management, ethics and organisational structure. CONCLUSIONS: Future studies with immune modifiers will also fail if not better structured (reduction of variance) to achieve uniform patient management in a complex clinical scenario. This new type of a single-centre trial aims to reduce the gap between animal experiments and clinical trials or--if it fails--at least demonstrates new ways for explaining the failures.

Algorithms↗