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.

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.

Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer.

BACKGROUND: The extent to which chemotherapy may relieve tumour-related symptoms, improve quality of life and prolong survival in patients with gastric cancer is not known in spite of the extensive use of this treatment modality. The aim of this study was to estimate any gain in the quantity and quality of life produced by chemotherapy in these patients. PATIENTS AND METHODS: Between January 1991 and February 1995, 61 patients with gastric cancer were randomized to either chemotherapy in addition to best supportive care or to best supportive care. Chemotherapy was allowed in the latter group if the supportive measures did not lead to palliation. Chemotherapy was the ELF-regimen consisting of 5-fluorouracil, leucovorin and etoposide, or, in elderly patients with poor performance, a 5-fluorouracil/leucovorin regimen (FLv). Quality of life was evaluated with the EORTC-QLQ-C30 instrument. RESULTS: More patients in the chemotherapy group (45%, 14/31) had an improved or prolonged high quality of life for a minimum period of 4 months compared to those in the best supportive care group (20%, 6/30, P < 0.05). A similar difference was seen in the treating physician's evaluation of whether the patient was subjectively improved or continued to do well for at least 4 months (17/31, 55% versus 6/30, 20%, P < 0.01). Overall survival was longer in the chemotherapy group (median 8 vs. 5 months) although the difference was not statistically significant (P = 0.12). After corrections for imbalances in pretreatment characteristics, chemotherapy treatment was, however, associated with a survival benefit (P = 0.003). Also, the quality-adjusted survival time and time to disease progression were longer for patients randomized to chemotherapy (median 5 vs. 2 months, P = 0.03). CONCLUSIONS: The results show that chemotherapy can add to both quantity and quality of life in advanced gastric cancer. The number of patients who benefit from treatment is, however, still rather limited.

Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer.

BACKGROUND: In certain patients with pancreatic and biliary cancer, chemotherapy may relieve tumour-related symptoms, improve quality of life and possibly prolong survival. The extent of these improvements is not completely known in spite of the extensive use of this treatment modality. The aim of this study was to estimate any gain in the quantity and quality of life produced by chemotherapy in patients with pancreatic and biliary cancer. PATIENTS AND METHODS: Between January 1991 and February 1995, 90 eligible patients with pancreatic or biliary cancer were randomized to either chemotherapy in addition to best supportive care or to best supportive care. Chemotherapy was allowed in the latter group if the supportive measures did not lead to palliation. Chemotherapy was either sequential 5-fluorouracil/leucovorin combined with etoposide (FELv) or, in elderly and poor performance patients, the same regimen without etoposide (FLv). Quality of life was evaluated with the EORTC-QLQ-C30 instrument. RESULTS: Mean scale scores in the QLQ-C30 improved more often/deteriorated less frequently in the chemotherapy group than in the best supportive care group. More patients in the chemotherapy group (36%, 17/49) had an improved or prolonged high quality of life for a minimum period of 4 months compared to those in the best supportive care group (10%, 4/41, P < 0.01). Overall survival was significantly longer in the chemotherapy group (median 6 vs. 2.5 months, P < 0.01). Also, the quality-adjusted survival time was longer for patients randomized to chemotherapy (median 4 vs. 1 months, P < 0.01). The effects were seen both in pancreatic and biliary cancer. CONCLUSIONS: The results show that chemotherapy can add to both quantity and quality of life in advanced pancreatic and biliary cancer. The number of patients who benefit from treatment is, however, still limited; for this reason careful selection before, and close monitoring during, treatment are necessary.

Prevention of relapse of reflux esophagitis after endoscopic healing: the efficacy and safety of omeprazole compared with ranitidine.

Ninety-eight patients with erosive and/or ulcerative esophagitis unhealed after at least 3 months' treatment with standard doses of cimetidine (greater than or equal to 1200 mg daily) or ranitidine (greater than or equal to 300 mg daily) were primarily included in an acute healing phase study, and 51 were allocated to 40 mg omeprazole once daily and 47 to 300 mg ranitidine twice daily. After 12 weeks of treatment, 46 (90%) patients given omeprazole were healed, compared with 22 (47%) allocated to ranitidine. Healed patients were then given maintenance treatment with either 20 mg omeprazole once daily or 150 mg ranitidine twice daily for 12 months. Plasma gastrin was determined and gastric mucosal biopsy specimens were obtained during the entire study to assess the structure of the exocrine and endocrine cell populations of the oxyntic mucosa. Sixty-seven per cent of the total number of patients randomized to omeprazole were maintained in clinical and endoscopic remission throughout the 12-month study period as compared with only 10% among those given ranitidine (p less than 0.0001). After 4 weeks of omeprazole treatment basal gastrin levels were slightly increased, with a 95% confidence interval for the change of from 8.6 to 16.9 pmol/l. No further increase in basal gastrin levels was observed during the ensuing study months. No significant histopathologic lesion was found in the oxyntic gland mucosa. In conclusion, omeprazole was far superior to ranitidine in preventing recurrence, a goal achieved without adverse events and significant abnormalities in the oxyntic mucosal exocrine or endocrine cells but with a moderate increase in basal gastrin levels.

Pneumatosis cystoides intestinalis in young patients. Case report.

A 19-year-old student with non-symptomatic pneumatosis cystoides intestinalis in the right colon is presented. He had no history of any pulmonary or other disease. According to a review of the literature there is no rational for any treatment or specific follow-up in patients with a non-symptomatic pneumatosis cystoides intestinalis.

Clinical results of reoperation after failed highly selective vagotomy.

The results after reoperation after failed highly selective vagotomy during a 10 year period have been reviewed retrospectively. Forty of 306 patients (13 percent) underwent reoperation due to recurrent ulcer (25 patients), severe dyspepsia without proved recurrence (12 patients), and gastric stasis without recurrence (3 patients). In the first two groups, 16 patients had a second vagotomy and 17 underwent partial gastrectomy, 10 with gastroduodenostomy and 7 with gastrojejunostomy. The need for a second reoperation was disquietingly high after both revagotomy (5 of 16 patients) and partial gastrectomy with gastroduodenostomy (4 of 10 patients). These results contrasted with a successful outcome in all seven patients who underwent reoperation with partial gastrectomy and gastrojejunostomy. At the time of follow-up, 85 percent of the reoperated patients (34 of 40 patients) were in Visick grade 1 or 2 as determined by their own judgement.

Clinical results 1-10 years after highly selective vagotomy in 306 patients with prepyloric and duodenal ulcer disease.

Overall clinical results were assessed 1-10 years after routinely performed highly selective vagotomy (HSV) in 326 consecutive patients suffering duodenal and prepyloric ulcer disease, operated on by 37 surgeons of varying seniority at a district general hospital. Three hundred and six (94 per cent) patients were followed up. No mortality was recorded after 326 primary and 50 reoperative procedures. Postoperative complications were few and diminished during the study period. Persistent moderate to severe dumping was found in 2.3 per cent of the patients; slight and periodic, but in no case disabling, diarrhoea in 11 per cent and gastric retention in 2.1 per cent. The overall clinical ulcer recurrence rate was 13.8 per cent, with a tendency towards better results during the second 5 year period. Significant differences were found between individual surgeons and groups of surgeons. Recurrences tended to be located more proximally than the primary ulcer. Fifty reoperations were performed in forty patients for ulcer recurrence (twenty-five), persistent ulcer-like symptoms (twelve) and gastric retention (three). When all recurrences and reoperations were classified as failures the symptomatic assessment according to Visick showed 67 per cent of the patients in grades I-II and 26 per cent in grade IV but the corresponding figures from the patients' own classification including the results of reoperations were 79 per cent and 7 per cent. It is concluded that for the time being HSV is the method of choice for the elective surgical treatment of duodenal and prepyloric ulcer disease.

Recurrences 1 to 10 years after highly selective vagotomy in prepyloric and duodenal ulcer disease. Frequency, pattern, and predictors.

Three hundred and six (94%) of all consecutive patients with prepyloric or duodenal ulcer disease undergoing highly selective vagotomy at a District General Hospital were followed up after 1 to 10 completed years of observation. The 5- and 10-year cumulative recurrence rates were 11.6% and 16.8%, respectively. These figures were not related to age, sex, duration of ulcer disease, or preoperative peak acid output. Prepyloric ulcers had a significantly higher recurrence rate than duodenal ulcers during the first 5 years but this difference was eliminated at 10 years. The recurrence rates varied highly significantly between different surgeons. The 5-year recurrence rate in patients operated during the first 5-year period amounted to 13.4% and was steadily increasing. A corresponding figure for those operated during the second 5-year period was 5.3% and remained constant after 3 years of observation. This difference might reflect an improved surgical technique initiated by repeated evaluation of the clinical results.

Bleeding as a complication to endoscopic biopsies from the gastric remnant after ulcer surgery.

Bleeding is a potential but rare complication after endoscopic biopsies of the gastric mucosa in non-operated patients. The resected stomach, however, seems to run an increased risk of this complication. In a retrospective study comprising 1843 consecutive biopsy examinations of the gastric remnant, 15 bleeding episodes were recorded (0.8%). The frequency of bleeding was 1.1% for the Billroth-II-resected stomach and 0.2% for the Billroth-I-resected stomach. In two patients the bleeding was excessive, requiring emergency surgery. Six other patients required blood transfusions. The observed frequency of bleeding was probably a minimal estimate, suggested by a 20% occult bleeding found in a small prospective study. When planning follow-up examination of patients who have had a gastrectomy, the risk of bleeding should be taken into account, and the patients should be appropriately informed and supervised.

The aerobic and anaerobic microflora of the gastric remnant more than 15 years after Billroth II resection.

The bacteriology of the gastric remnant contents was examined in 150 patients 15-20 years after Billroth II resection for duodenal ulcer disease. Samples of gastric contents were aspirated through a gastroscope, and aerobic and anaerobic microflora were cultured and analyzed semiquantitatively. All patients but one had bacterial growth, with a mean number of 6.8 strains per remnant. One third of the bacterial strains were anaerobic, and many of them had their normal habitat in the colon. The role played by bacteria of the gastric remnant in the etiology of mucosal pathology and gastric remnant disease is discussed.

Cimetidine or propantheline combined with antacid therapy for short-term treatment of duodenal ulcer.

Seventy-one patients with duodenal ulcer disease completed a 3- to 6-week controlled randomized trial in which cimetidine (1 g daily) was compared with an optimally effective dose of propantheline. Both groups had free access to an antacid suspension. There were no significant differences between the groups concerning ulcer healing, relief of ulcer symptoms, antacid consumption, or patient compliance. After 3 weeks of treatment, endoscopic examination revealed complete ulcer healing in 63% of the cimetidine and 47% of the propantheline treated patients. The corresponding figures after 6 weeks were 94% and 86%, respectively. After 12 weeks, ulcer recurrence was confirmed in 26% of the cimetidine- and 23% of the propantheline-treated patients. Except for the absence of anticholinergic adverse reactions, no significant advantages could be confirmed for combined cimetidine and antacid treatment.

Fasting blood levels of gastrin, somatostatin, and pancreatic polypeptide in peptic ulcer disease.

Fasting plasma levels of immunoreactive gastrin, somatostatin, and pancreatic polypeptide (PP) were determined in 67 patients with an endoscopically proven duodenal, pyloric, or prepyloric ulcer. Pretreatment gastrin (45.6 +/- 53.6 pmol/l, mean +/- S.D.) and somatostatin (54.5 +/- 27.5 pg/ml) did not differ significantly from those in 22 healthy controls (21.8 +/- 20.2 pmol/l and 64.8 +/- 24.7 pg/ml, respectively). The gastrin and somatostatin levels were not changed by 3 weeks of treatment either with propantheline and antacids or with cimetidine and antacids. The mean PP value before treatment was significantly (p less than 0.01) higher in duodenal ulcer patients (0.76 +/- 0.55 ng/ml) than in healthy subjects of similar age (0.36 +/- 0.26 ng/ml). The increased PP level was not lowered significantly by medical treatment even when this resulted in healing of the ulcer.

Scintigraphic assessment of biliary reflux into the residual stomach after subtotal gastrectomy and gastrojejunostomy.

A method is described for evaluating biliary reflux into the gastric remnant after subtotal gastrectomy, avoiding naso- or orogastric intubation. Gamma camera detection and continuous recording of the distribution and possible gastric reflux of 99Tcm-HIDA after intravenous injection was employed, before and after stimulation of bile flow by a fatty meal. The technique is simple and specific, but further clinical evaluation is needed.

Clinical results of 229 patients with duodenal ulcer 1-6 years after highly selective vagotomy.

The aim of this study was to assess the clinical results after highly selective vagotomy (HSV) when used routinely at a district general hospital. A total of 229 patients with chronic duodenal or prepyloric ulcers was included in a 92 per cent complete follow-up 1-6 years after an elective HSV without drainage. There was no postoperative mortality, and the frequency of postoperative complicatons was low. Transient dysphagia and early fullness each occurred in about a quarter of the patients, whereas persistent dumping was found only in 1.3 per cent and diarrhea in 2.2 per cent of the patients. Recurrent ulcer was diagnosed in 12.7 per cent of the patients, but this figure decreased to 9.3 per cent after exclusion of one of the 24 surgeons involved. The overall clinical results according to the modified Visick classification were recorded as excellent or very good in 70 per cent and unsatisfactory in 20 per cent. The failures were almost exclusively due to a proved or suspected recurrence or to gastric retention, and further operations have been performed on 27 of these patients. After reoperation only 8 patients (3.5 per cent) remained failures according to the patient's own judgement at the time of follow-up. The recurrence ratein this study was considered disquietingly high with regard to the short observation time. However, other obvious advantages of the method and the possibility of improved results after adjustment of the surgical technique were considered to justify continued use of HSV as a routine procedure.

Colonoscopic appendectomy. Report of two cases.

Colonoscopic appendectomy has been performed in two patients, who had had their appendices inverted into the caecum as an incidental procedure at earlier abdominal surgery.

Posterolateral diaphragmatic hernia--long-term results.

During the years 1965--1974, 125 cases of posterolateral diaphragmatic hernia have been operated at five departments of pediatric surgery in Sweden. The overall operative mortality was 50%. A follow-up investigation included 19 cases, where in 12 cases spirometry and in 11 cases studies of the mobility of the diaphragm were included. Physical examination revealed excellent results in most cases. Lung function studies, however, show a moderate (20--30%) reduction, which is not surprising with regard to lung hypoplasia and impaired movement of the diaphragm on the operated side. In adolescence and younger age, these patients are mostly in excellent condition; but later, when lung function is also reduced by the age factor, their neonatal condition may be of importance.

Clinical results and recurrences 1-4 years after parietal cell vagotomy in duodenal ulcer patients.

168 patients with duodenal or prepyloric ulcer, treated with parietal cell vagotomy (PCV), were followed up one to four years after operation. 67% of the patients had more than 5 years' history of ulcer disease and in 44% preoperative bleeding or perforation could be confirmed. According to the modified Visick classification the clinical results were considered excellent or very good in 71%, with a marked tendency to better results for those surgeons with the greatest experience in performing parietal cell vagotomy. The result was considered unsatisfactory in 25 patients (15%) and this was in all cases due to reoperation and/or recurrent ulcer. There was no postoperative mortality and a low frequency of postoperative complications. Dumping was found in only one patient and mild diarrhoea in two. At follow-up, 16 patients (9.5%) had had a proven and 8 (4.5%) a suspected recurrent ulcer and 3 had gastric retention without recurrence. The recurrence rate was very high for those patients operated during the first year after the introduction of PCV, but then decreased significantly. 18 patients required reoperation. Antrectomy or truncal vagotomy with drainage is considered the method of choice for patients with an incomplete PCV and recurrent ulcer.