Discomfort five years after laparoscopic and Shouldice inguinal hernia repair: a randomised trial with 867 patients. A report from the SMIL study group.

BACKGROUND: In recent years long-term discomfort after inguinal hernia surgery has become an issue of great concern to hernia surgeons. Long-term results on discomfort from large randomised studies are sparse. METHODS: One-thousand one-hundred and eighty-three patients were randomised in a multicentre trial with the primary aim of comparing recurrence rates after laparoscopic TAPP and Shouldice repair. Evaluating late discomfort and its possible risk factors were secondary objectives, and are reported here. The patients were clinically examined after 1 and 5 years, and answered questionnaires 2 and 3 years postoperation. RESULTS: Of 1,068 operated patients, 867 were eligible for analysis after 5 years (81.2%). The percentage of patients experiencing discomfort of any kind were 8.5% in the TAPP group and 11.4% (p = 0.156) in the Shouldice group. Although discomfort was usually mild it was severe for 0.2 and 0.7%, respectively. Severe pain the first postoperative week was a risk factor for late discomfort in the Shouldice group (OR 2.25, P = 0.022) but not in the TAPP group. No other risk factor for late discomfort was found. CONCLUSION: There was no difference between late discomfort at five-year follow-up after laparoscopic TAPP and Shouldice repair. Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in Shouldice patients.

Recurrent inguinal hernia: randomized multicenter trial comparing laparoscopic and Lichtenstein repair.

BACKGROUND: The optimal treatment for recurrent inguinal hernia is of concern due to the high frequency of recurrence. METHODS: This randomized multicenter study compared the short- and long-term results for recurrent inguinal hernia repair by either the laparoscopic transabdominal preperitoneal patch (TAPP) procedure or the Lichtenstein technique. RESULTS: A total of 147 patients underwent surgery (73 TAPP and 74 Lichtenstein). The operating time was 65 min (range, 23-165 min) for the TAPP group and 64 min (range, 25-135 min) for the Lichtenstein group. Patients who underwent TAPP reported significantly less postoperative pain and shorter sick leave (8 vs 16 days). The recurrence rate 5 years after surgery was 19% for the TAPP group and 18% for the Lichtenstein group. CONCLUSION: The short-term advantage for patients who undergo the laparoscopic technique is less postoperative pain and shorter sick leave. In the long term, no differences were observed in the chronic pain or recurrence rate.

Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair.

BACKGROUND: Laparoscopic herniorrhaphy has emerged as a recognized operative method for inguinal hernia repair. This study compared the short-term results of two tension-free methods of repair: totally extraperitoneal (TEP) laparoscopic patch repair and the open Lichtenstein mesh technique. METHODS: A total of 1513 men from 11 hospitals who presented with a primary unilateral inguinal hernia were randomized to one of the two methods. Operating time, short-term complications, reoperations, postoperative pain, consumption of analgesics, sick leave and time to resumption of normal physical activities were recorded. RESULTS: Some 1371 of the 1513 men underwent surgery, 665 in the TEP group and 706 in the Lichtenstein group. The median duration of operation was 55 min for both procedures and 91.0 percent of the patients in both groups were discharged on the day of operation. Patients in the TEP group experienced less postoperative pain (P<0.001), consumed fewer analgesics (P<0.001), had a shorter period of sick leave (7 versus 12 days; P<0.001) and a shorter time to resumption of normal physical activity (20 versus 31 days; P<0.001). CONCLUSION: The TEP technique took no longer to perform, and was associated with less postoperative pain, a shorter period of sick leave and a faster recovery, compared with open Lichtenstein hernia repair.

Randomized clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia.

BACKGROUND: The Shouldice technique is the 'gold standard' of open non-mesh hernia repair. The aim of this study was to compare 5-year recurrence rates after Shouldice and laparoscopic transabdominal preperitoneal patch (TAPP) repair for primary inguinal hernia. METHOD: Men with a primary unilateral inguinal hernia were randomized to either Shouldice or TAPP operation. An independent observer scored the surgeons' performance. Follow-up comprised clinical examination after 1 year, a questionnaire after 2 and 3 years, and a clinical examination after 5 years. RESULTS: Between February 1993 and March 1996, 1183 patients were included. Nine hundred and twenty patients were followed for 5 years, 454 in the TAPP group and 466 in the Shouldice group. Recurrences were evenly distributed between groups throughout the follow-up period. The cumulative recurrence rate after 5 years was 6.6 per cent in the TAPP group and 6.7 per cent in the Shouldice group. Postoperative pain was a risk factor for recurrence after Shouldice operation but not after TAPP repair. There was a correlation between a low surgeon's performance score and recurrence. CONCLUSION: The 5-year recurrence rate is acceptable, with no difference between TAPP and Shouldice repair. Poor operative performance resulted in a higher recurrence rate. The TAPP operation represents an excellent alternative for primary inguinal hernia repair.

Long-term effects of eradication of Helicobacter pylori on relapse and histology in gastric ulcer patients: a two-year follow-up study.

BACKGROUND: The main purpose of this study was to compare omeprazole (ome) plus two antibiotics (OMC) with omeprazole plus placebo (OP) with regard to gastric ulcer relapse for a period of 2 years in patients who were Helicobacter pylori-positive at inclusion. METHODS: Using double-blind randomization 125 patients with gastric ulcer were treated with either OMC (ome 20 mg b.i.d., metronidazole 400 mg b.i.d., clarithromycin 250 mg b.i.d.) (n = 64) or OP (ome 20 mg and placebo) (n = 61) for 1 week, followed by ome 20-40 mg o.d. until healing was confirmed endoscopically after 4, 8 or 12 weeks. Endoscopy and H. pylori diagnostics using culture, histology and serology were performed 6, 12 and 24 months after treatment or at symptomatic relapse. At inclusion, 35% of the OMC group and 38% of the OP group were taking non-steroidal anti-inflammatory drugs (NSAIDs). Nine percent (11/125) of the ulcers were malignant. RESULTS: The prevalence of H. pylori was 82% and the eradication rate 88% in the OMC group and 3% in the OP group. More than 90% of the ulcers were healed after 12 weeks. After 2 years, 76% of patients in the OMC group were in remission compared with 28% in the OP group (ITT) (P < 0.001). Sixty percent of patients in the OMC group that continued to take NSAIDs were in remission after 2 years compared with none in the OP group. Atrophy but not intestinal metaplasia decreased after treatment. CONCLUSIONS: Gastric ulcers are mainly caused by H. pylori, and relapse is effectively prevented by H. pylori eradication, even in patients on NSAIDs.

Long-term results from laparoscopic common bile duct exploration.

BACKGROUND: The aim of this study was to evaluate the long-term results after laparoscopic common bile duct exploration (LCBDE). METHODS: A retrospective review of 175 consecutive patients who underwent attempted LCBDE between 1992 and 1999 was conducted. Laparoscopic transcystic exploration was accomplished in 110 patients and laparoscopic choledochotomy in 52 patients. Conversion to an open common bile duct exploration was required for 13 patients (7.4%). Retained common bile duct stones occurred in eight patients (4.6%). The 30-day postoperative morbidity was 6.9%, and there was no 30-day mortality. All the patients (alive and localized) received a questionnaire evaluating long-term results. RESULTS: Of the 175 patients, 169 (4 unrelated deaths and 2 patients lost to follow-up evaluation) received and 152 (90%) returned the questionnaire. The follow-up period ranged from 6 to 72 months (median, 36 months). One patient developed recurrent common bile duct stones. There were no signs or evidence of common bile duct stricture in any patient. CONCLUSION: The LCBDE procedure can be performed without increased risk of late bile duct complications.

Postoperative convalescence after inguinal hernia surgery: prospective randomized multicenter study of laparoscopic versus shouldice inguinal hernia repair in 1042 patients.

Interest in inguinal hernia surgery has increased significantly with the introduction of new operating techniques during the past decade. This multicenter study compared short-term results in patients treated by the laparoscopic transabdominal preperitoneal patch technique (TAPP; n = 518) and the Shouldice technique (n = 524). We evaluated demographics, operative data, complications, hospital stay, postoperative pain, use of cs, functional status, sick leave, and complaints up to 3 months postoperatively. The median operating time was shorter in the Shouldice group (55 vs. 65 min), but there were no significant differences in complication rates, and major complications were rare. The hospital stay was 1 day or less in over 98% of cases in both groups, but more operations were performed on outpatient basis in the Shouldice group. In the TAPP group postoperative pain and analgesic consumption were less, postoperative functional status was better, and sick leave was shorter (10 vs. 14 days). These results show that the two methods are equally safe and have few major complications. The TAPP operation is associated with less postoperative pain, better postoperative functional status, and shorter sick leave, but at the price of a longer operating time.

Does training in a virtual reality simulator improve surgical performance?

BACKGROUND: The development of computerized surgical simulators in a virtual reality environment demands models for proper validation. Recent investigations have shown that a virtual reality simulator (MIST-VR) is a reliable tool for the assessment of laparoscopic psychomotor skills and that it improves the automation of the so-called fulcrum effect. Therefore, we set out to determine whether training with the MIST-VR would improve the surgical performance of surgically inexperienced medical students and to see if results obtained in the simulator would correlate with surgical performance. METHODS: A total of 29 medical students were randomized into two groups. One group received preoperative MIST-VR training. Both groups then performed a simulated laparoscopic appendectomy in a pig. The operations were videotaped and examined by three independent observers. RESULTS: There was no significant difference in performance between the two groups. The performance with the MIST-VR correlated with the results in surgery. CONCLUSION: A method that can measure surgical skill, based on the scoring of independent observers who view videotaped performances, seems to be reliable. MIST-VR did not improve the surgical skills of the subjects, but the results with MIST-VR did predict surgical outcome.

Laparoscopic management of common bile duct stones.

There are various techniques available for laparoscopic exploration of the common bile duct, but the most widely used are pharmacological relaxation of the sphincter of Oddi and saline flushing, laparoscopic transcystic exploration, and laparoscopic choledochotomy. Altogether 1319 patients have been reported in retrospective and prospective uncontrolled studies with more than 50 patients in each. The conclusion is that it is possible to make a laparoscopic exploration of the common bile duct in selected cases with low morbidity and mortality. As surgeons gain more experience they also learn who is and who is not a suitable candidate for this surgical option.

Increased risk of cancer in ulcerative colitis: a population-based cohort study.

OBJECTIVE: There is an increased risk of colorectal cancer among patients with ulcerative colitis (UC). However, the overall and site specific cancer risks in these patients have been investigated to a limited extent. To study the association between UC and cancer, a population-based study of 1547 patients with UC in Stockholm diagnosed between 1955 and 1984 was carried out. METHODS: The patients were followed in both the National Cancer Register and the National Cause of Death Register until 1989. For comparisons, regional cancer incidence rates in Stockholm County were used together with individually computed person-years at risk in the UC disease cohort. RESULTS: A total of 121 malignancies occurred among 97 individuals as compared with 89.8 expected (standardized morbidity ratio [SMR] = 1.4; 95% confidence interval (CI), 1.1-1.6). Overall, an excess number of colorectal cancers (SMR, 4.1; 95% CI, 2.7-5.8), and hepatobiliary cancers in men (SMR = 6.0; 95% CI, 2.8-11.1) associated with primary sclerosing cholangitis, was observed. The risk of pulmonary cancer was decreased (SMR = 0.3; 95% CI, 0.1-0.9). In all, 91 extracolonic malignancies were observed, compared with the 82.3 expected (SMR = 1.11; 95% CI, 0.9-1.3). CONCLUSIONS: In UC patients, the overall cancer incidence is increased mainly because of an increased incidence of colorectal and hepatobiliary cancer. This increase is partly counterbalanced by a decreased risk of pulmonary cancer compared with that in the general population.

Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. The IOIBD Budesonide Study Group.

BACKGROUND & AIMS: Prevention of postoperative recurrence after resection for Crohn's disease (CD) would be of great clinical benefit. The efficacy of oral budesonide for prevention of endoscopic recurrence was evaluated in patients undergoing resection for ileal or ileocecal CD. METHODS: Sixty-three patients received budesonide and 66 received placebo in a double-blind, randomized trial with parallel groups. Ileocolonoscopy, including biopsy, was performed after 3 and 12 months. Indications for surgery were fibrostenosis (78 patients), disease activity (41), and other reasons (10). RESULTS: The frequency of endoscopic recurrence did not differ between the groups at 3 and 12 months. In patients with disease activity as indication for surgery, the endoscopic recurrence rate at the anastomosis was lower in the budesonide group at 3 months, although not significantly (21% vs. 47%; P = 0.11), and at 12 months (32% vs. 65%; P = 0.047). There was no such difference with respect to fibrostenosis as indication for surgery. No differences in adverse event patterns were found between the two groups. CONCLUSIONS: Oral budesonide, 6 mg daily, offered no benefit in prevention of endoscopic recurrence after surgery for ileal/ileocecal fibrostenotic CD but decreased the recurrence rate in patients who had undergone surgery for disease activity.

Diagnostic laparoscopy in 1043 patients with suspected acute appendicitis.

OBJECTIVE: To evaluate the efficacy of diagnostic laparoscopy in patients with suspected acute appendicitis, the number of complications associated with the laparoscopic technique, and the effect of leaving a macroscopically normal-looking appendix in place. DESIGN: Three prospective protocols. SETTING: Three departments of surgery, one in Norway and two in Sweden. SUBJECTS: 1043 patients aged 15 years or over. INTERVENTIONS: Diagnostic laparoscopy in patients with signs and symptoms of acute appendicitis who were to be operated on. MAIN OUTCOME MEASURES: Morbidity, mortality, and histological appearance of removed appendices, and outcome whether or not the patient was operated on. RESULTS: 819 patients had appendectomies (61% laparoscopically and 39% by conversion to open operation) with a total complication rate of 10%. In 211 patients a diagnostic laparoscopy was done as a single procedure. There were 181 women in this group and 86 of them had gynaecological disorders. The complication rate was 2% among these 211 patients and after a follow up of two years no patients had been readmitted for appendicectomy. 13 patients were subjected to other open procedures. The overall mortality was 0.4%. CONCLUSION: Diagnostic laparoscopy is safe and can be recommended in patients with suspected acute appendicitis, particularly in women. A macroscopically normal-looking appendix can be left in place.

[Laparoscopy possible even in cholelithiasis. Results for 96 patients from three different hospitals are reviewed]. / Laparoskopi möjlig även vid koledokussten. Resultaten för 96 patienter från tre sjukhus redovisas.

At laparoscopic cholecystectomy, a procedure routinely used at Swedish surgery departments today, common bile duct stones are found to be present in 5-10 per cent of cases. During recent years, several alternative procedures have been evolved for the management of duct stones, such as operative or postoperative endoscopic sphincterolomy, or conversion to open surgery and choledochotomy. The article gives an account of laparoscopic treatment of common bile duct stones, and results obtained in 96 patients from three surgery departments in Sweden. Three different primary techniques were used: saline flushing via the cholangiography catheter, after intravenous injection of 1 mg of glucagon (in six cases of small stones); transcystic common duct exploration (TCDE), with cholodochoscopy and a Dermia basket (68 cases); and laparoscopic choledochotomy and choledochoscopy (22 cases). The success rate was 88 per cent (84/96), and mortality zero. In many cases the postoperative course was similar to that of patients undergoing laparoscopic cholecystectomy alone. We recommend TCDE in cases of common bile duct stones of no more than 8-9 mm in diameter, and where the cystic duct is large. Single-stage laparoscopic treatment of bile duct stones seems to be a safe and effective method of dealing with two problems in the same setting, and is an important alternative in the management of duct stones.

Survival and cause-specific mortality in inflammatory bowel disease: a population-based cohort study.

BACKGROUND & AIMS: A population-based cohort study of 1251 subjects with Crohn's disease and 1547 subjects with ulcerative colitis, diagnosed in Stockholm between 1955 and 1984, was performed to examine the survival, changes in survival over time, and cause-specific mortality. METHODS: The cohort of patients was followed up in the National Cause-of-Death register until 1990. National mortality rates were used for comparisons. RESULTS: The observed vs. expected survival rate after 15 years was 93.7% (95% confidence interval [CI], 91.8%-95.7%) for Crohn's disease and 94.2% (95% CI, 92.4%-96.1%) for ulcerative colitis. Overall, 174 deaths occurred vs 115.42 expected (standardized mortality ratio, 1.51; 95% CI, 1.29-1.75) in Crohn's disease. In ulcerative colitis, 255 deaths occurred compared with 186.78 expected (standardized mortality ration, 1.37; 95% CI, 1.20-1.54). Inflammatory bowel disease was the major contributor to the elevated mortality rate, but mortality from colorectal cancer, asthma, and non-alcohol-related liver diseases was increased in ulcerative colitis; mortality from other gastrointestinal diseases was increased in ulcerative colitis as well as in Crohn's disease. CONCLUSIONS: Data in the present study are compatible with the hypothesis that subjects with inflammatory bowel disease have an increased mortality compared with the general population.

Decrease in muscle glutamine, ribosomes, and the nitrogen losses are similar after laparoscopic compared with open cholecystectomy during the immediate postoperative period.

BACKGROUND: The purpose of the study was to compare the postoperative muscle amino acid pattern, the ribosome concentration and size distribution, and postoperative nitrogen balance in patients who underwent either laparoscopic or open cholecystectomy. METHODS: Patients who underwent cholecystectomy by means of either laparoscopy (n=8;LAP) or laparotomy (n=8;OPEN) were studied. The concentrations of amino acids, ribosomes, and polyribosomes, reflecting protein synthesis, were determined in skeletal muscle tissue before operation and on postoperative day 2. The cumulated nitrogen balance was determined. RESULTS. Decreases in muscle glutamine (26.7% +/- 8.4% in the LAP group and 30.3% and +/- 4.5% in the OPEN group) and in polyribosomes (28.7% +/- 6.5% in the LAP group and 23.6% +/- 8.5% in the OPEN group) were observed without differences between the groups (mean +/- SEM). The nitrogen losses were similar in both groups (15.2 +/-1.6 gm in the LAP group and 15.5 +/- 1.2 gm in the OPEN group). CONCLUSION: A stress++ response with effects on amino acid and protein metabolism in muscle in present also after laparoscopic cholecystectomy. On postoperative day 2 this response is of similar magnitude after both the laparoscopic and the open procedures.

Crohn's disease and cancer: a population-based cohort study.

BACKGROUND/AIMS: To study the association between Crohn's disease and cancer, we performed a population-based study of 1251 subjects with Crohn's disease diagnosed in Stockholm from 1955 to 1984 and followed in both the National Cancer Register and the National Cause-of-Death Register until 1989. METHODS: For comparisons, regional cancer incidence rates in Stockholm County were used together with individually computed person-years at risk in the Crohn's disease cohort. RESULTS: Overall, 69 malignancies occurred among 67 individuals as compared with 59.80 expected malignancies (standardized morbidity ratio [SMR] = 1.15; 95% confidence interval, 0.90-1.46). An excess number of cancers of the upper gastrointestinal tract (SMR, 3.05; 95% confidence interval, 1.67-5.11) was observed, mainly because of an increased number of cancers of the small intestine (SMR, 15.64; 95% confidence interval, 4.26-40.06). An increased occurrence of urinary bladder cancer was also observed (SMR, 2.68; 95% confidence interval, 1.08-5.53). CONCLUSIONS: The occurrence of colorectal cancer was not increased.

Short-term starvation alters the free amino acid content of the human intestinal mucosa.

1. The effects of short-term starvation and refeeding on the free amino acid concentrations of the intestinal mucosa were characterized in male subjects (n = 6), using endoscopically obtained biopsy specimens from the duodenum and from all four segments of the colon. 2. The alterations in the amino acid concentrations in response to short-term starvation were overall uniform in both duodenal and colonic mucosa as well as in plasma. Most amino acids decreased, whereas branched-chain amino acids increased. 3. In the colon, glutamic acid and glutamine decreased during the starvation period, whereas they remained unaltered in the duodenum. This was the major difference in response to short-term starvation between the amino acid concentrations in the intestinal mucosa of the duodenum and colon. 4. Refeeding for 3 days normalized the amino acid concentrations except for glutamic acid, asparagine and histidine, which remained low in the colon, and threonine, which showed an overshoot in both parts of the intestine. 5. The changes in mucosal amino acid concentrations seen in response to starvation and refeeding were uniform in the four segments of the colon. This suggests that sampling from the rectum/sigmoid colon will give representative values for the free amino acid concentrations of the entire large intestine.

Free amino acids in biopsy specimens from the human colonic mucosa.

The content of free amino acids and total protein was determined in endoscopic biopsy specimens from the rectum, descending colon, transverse colon, and ascending colon in 10 patients. The amino acids were quantified by ion-exchange chromatography and were detected by fluorescence. The amino acid pattern and the rank order of the individual amino acids in the colon were different compared to those in plasma. Glutamate, taurine, aspartate, glutamine, glycine, alanine, serine, lysine, valine, and ornithine were the 10 most abundant amino acids in the colon. The rank order was the same in all of the different segments of the colon. The concentrations of the amino acids decreased the more aborally the biopsies were taken. The protein content in the rectum was significantly lower than that in the transverse colon, but there were no difference between the different segments otherwise. The study demonstrated the possibility of determining free amino acids from endoscopic biopsies of human colonic mucosa. Biopsy specimens from the descending colon and/or rectum/sigmoid colon may be considered representative of the entire large intestine. The technique may be used for repeated sampling in studies of the amino acid metabolism of the intestinal mucosa.

The content of free amino acids in the human duodenal mucosa.

The free amino acid concentrations and the total protein content of the duodenal mucosa were determined in biopsy specimens obtained during endoscopic examinations in 10 healthy subjects. The amino acids were separated and quantified by ion exchange chromatography using fluorescence detection. The protein content was analysed according to Lowry. The amino acid pattern found in the duodenal mucosa was quite different from that in the plasma. The total amounts of all individual free amino acids were considerably higher in the mucosa than in the plasma (16.2 +/- 0.6 mmol/kg biopsy weight compared to 2.4 +/- 0.1 mmol/l). Taurine, glutamate and aspartate constituted more then 65% of the total content of all amino acids in the mucosa. Glutamine, the most abundant amino acid in plasma (21%), ranked only as sixth in the duodenal mucosa (4%); still, the absolute concentrations were quite similar in the mucosa and plasma (0.60 +/- 0.05 mmol/kg vs. 0.53 +/- 0.02 mmol/l). This study demonstrates the possibility of determining free amino acids in endoscopic biopsy specimens from the human duodenum. The technique is recommended for repeated sampling in clinical studies on the amino acid metabolism of the intestinal mucosa.