Efficacy and safety assessment of ERCP in patients with malignant biliary obstruction.

BACKGROUND: To assess the efficacy and safety of Endoscopic retrograde cholangiopancreatography (ERCP) for malignant biliary obstruction (MBO). MATERIAL AND METHODS: A review of all ERCP-procedures performed at Akershus University Hospital during the six year period between 2009-2014 was analysed. Data for the period 2009- 2013 were obtained retrospectively and prospectively for 2014. Patients with jaundice due to MBO were selected for the present study. RESULTS: A total of 210 patients (51% females), median age of 70 years (range 33-96) were included. The total number of procedures were 314, whereof 218 (69%) were successful and 96 (31%) were failures. 292 procedures were palliative and 22 procedures were intended as 'bridge to surgery' whereof 15 patients underwent surgery. Pancreatic carcinoma occurred in 105 (50%) patients and was the most common reason for MBO. Straight plastic stents (I-stents) were applied in 145 (74%), double-pigtail stents (JJ-stents) in 29 (15%), self-expanding metal stent (SEMS) in 18 (9%) procedures and in 3 procedures (1.5%) an I-stent was inserted through an indwelling SEMS. Median duration of stentpatency in months was 2 (range 0-74) for I-stent, 1 (range 0-29) for JJ-stent and 4 (range 0-29) for SEMS. The rates of complication and mortality due to complication were 8.9% and 1.3% per procedure. CONCLUSION: Adequate drainage of MBO by ERCP was obtained in 69%. The rates of complication and procedure related mortality were at acceptable levels.

Prophylactic mesh at end-colostomy construction reduces parastomal hernia rate: a randomized trial.

AIM: Parastomal hernia (PSH) is the most common complication of an end-colostomy and about one-quarter of patients need operative repair, which is often unsuccessful. A randomized trial was carried out to compare the results of using mesh or no mesh at the time of formation of a colostomy with the clinical identification of PSH as the primary outcome. METHOD: In this two-centre randomized trial (Oslo University Hospital and Sykehuset Innlandet Hospital Trust, Norway), patients with rectal cancer undergoing open pelvic surgery were randomized to receive a retromuscular synthetic mesh (study group, n = 32) or no mesh (control group, n = 26) at the time of end-colostomy formation. Postoperative follow up was not blinded and included clinical examination and routine CT. RESULTS: The median period of follow up was 40 (range: 84) months. There were no differences in demographic variables or complications between the study and control groups. PSH developed in two patients of the study group and in 12 of the control group [OR = 0.04 (95% CI: 0.01-0.30) and hazard ratio 0.134 (95% CI: 0.030-0.603); P < 0.001]. The number needed to treat to avoid one PSH was 2.5 patients. CT demonstrated an increase over time in the size of the fascial orifice in patients with PSH without mesh prophylaxis, in contrast to a stable size in patients with mesh and in the control patients who did not develop PSH. CONCLUSION: The retromuscular insertion of synthetic mesh at the time of formation of an end-colostomy reduced the risk of PSH.

Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure.

PURPOSE: Supposing divergent aetiology, we found it interesting to investigate outcomes between primary (PH) versus incisional (IH) hernias. In addition, we wanted to analyse the effect of defect closure and mesh fixation techniques. METHODS: 37 patients with PH and 70 with IH were enrolled in a prospective cohort-study, treated with laparoscopic ventral hernia repair (LVHR) and randomised to ± transfascial sutures. In addition, we analysed results from a retrospective study with 36 PH and 51 IH patients. Mean follow-up time was 38 months in the prospective study and 27 months in the retrospective study. RESULTS: 35 % of PH's and 10 % of IH's were recurrences after previous suture repair. No late infections or mesh removals occurred. Recurrence rates in the prospective study were 0 vs. 4.3 % (p = 0.55) and the complication rates were 16 vs. 27 % (p = 0.24) in favour of the PH cohort. The IH group had a mesh protrusion rate of 13 vs. 5 % in the PH group (p = 0.32), and significantly (p < 0.01) larger hernias and adhesion score, longer operating time (100 vs. 79 min) and admission time (2.8 vs. 1.6 days). Closure of the hernia defect did not influence rate of seroma, pain at 2 months, protrusion or recurrence. An overall increased complication rate was seen after defect closure (OR 3.42; CI 1.25-9.33). CONCLUSIONS: With PH, in comparison to IH treated with LVHR, no differences were observed regarding recurrence, protrusion or complication rates. Defect closure (raphe), when using absorbable suture, did not benefit long-term outcomes and caused a higher overall complication rate. (ClinicalTrials.gov number: NCT00455299).

Gut perforation caused by biliary endoprosthesis.

Two cases are reported of perforation of the gut caused by biliary endoprosthesies in the three-year period 1993-1995. The first patient was an 81-year-old man who had perforation of the terminal ileum caused by a straight 10 French/7 cm stent which had been dislodged from the bile duct; he underwent laparotomy but did not recover. The second patient was an 86-year-old man who had perforation of the sigmoid colon caused by a straight 7 French/5 cm stent left in the duodenum during a stent exchange procedure; he was successfully treated laparoscopically. Two cases of gut perforation in a three-year period is a rather high rate of this rare complication of placement of biliary endoprostheses.

Laparoscopic and open operation in patients with perforated peptic ulcer.

OBJECTIVES: To compare the results of laparoscopic and open operations in patients with perforated peptic ulcer. DESIGN: Retrospective analysis. SETTING: Central hospital, Norway. SUBJECTS: 74 patients (36 men, 38 women, median age 69.5 years (18-86)) admitted with perforated peptic ulcers from November 1991-May 1996. INTERVENTIONS: Suture of the ulcer, patching with the greater omentum and lavage, in 49 by open operation and 25 laparoscopically. MAIN OUTCOME MEASURES: Duration of postoperative hospital stay, operating time, number of doses of analgesic, postoperative body temperature, complications, and mortality. RESULTS: There was a significant difference (p = 0.0001) in median operating time: 100 minutes (range 48-160) in the laparoscopic group and 50 minutes (range 20-160) in the open group. The median hospital stay was 8 days in both groups: range 3-23 days in the laparoscopic group and 2-28 days in the open group. There were no significant differences between the two groups with regard to median number of doses of analgesic, median body temperature, complications or mortality. CONCLUSION: Laparoscopic operation for perforated peptic ulcer can be considered as safe as open operation.

[Laparoscopic splenectomy]. / Laparoskopisk splenektomi.

From 1995 to 1998, 14 patients have been treated with laparoscopic splenectomy. Seven patients had immune thrombocytopenic purpura (ITP), six hereditary spherocytosis and one chronic myelomonocytic leukaemia with trombocytopenia. 12 of the patients had normal or nearly normal sized spleen. Median duration of surgery was 156 minutes and the median postoperative hospital stay four days. All operations were completed laparoscopically. Three patients had postoperative fever without any sign of infection, one developed urinary retention and one was readmitted with pneumonia. The patient with chronic myelomonocytic leukaemia died 15 days postoperatively from an intracerebral bleeding. Two patients suffer from relapse of trombocytopenia, one is treated with steroids. Laparoscopic splenectomy can be performed safely in patients with normal sized spleen with all the advantages of minimal access surgery. However, problems related to identification of accessory spleens and splenectomy in patients with splenomegali, should be further evaluated.

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.

Development of play-the-winner design: weighting and accumulation of information.

BACKGROUND: Play-the-Winner (PTW) design was compared with Weighted-Play-the-Winner (WPW) design with regard to sensitivity to discriminate between treatments. METHODS: In total, 231 patients undergoing digestive surgery were included in a PTW study comparing safety of enoxaparin and dextran-70 in the prevention of venous thrombo-embolism. In the PTW model each patient was classified as a 'winner' or 'loser'. The treatment was changed when a patient was classified as 'loser', otherwise the same treatment was continued for the next patient. The study was performed by using a PTW design, but with all assessments needed for a WPW simulation. In the WPW design, a 'loser score' was calculated for each patient and summarized to a 'loser index' for consecutive patients given the same treatment. When this index exceeded a predefined value, treatment was changed and the 'loser index' set to zero. The WPW model with inheritance (WPWI) is identical to WPW, except that the overload of 'loser index' from the previous sequence with the same treatment was used as the starting value for the next. RESULTS: The PTW study revealed superiority of enoxaparin. This was enforced in the WPW model and further increased by WPWI. CONCLUSION: Changing from the PTW to WPW design and further to WPWI increased the sensitivity of the model, but at the same time the complexity of the design.

Prediction of common bile duct stones prior to cholecystectomy: a prospective validation of a discriminant analysis function.

BACKGROUND: Selection routines for preoperative endoscopic retrograde cholangiopancreatography (ERCP) in patients with symptomatic gallstone disease should give a low frequency of both false-negative ERCP results and residual common bile duct stones (CBDS). OBJECTIVE: To validate a discriminant function (DF) based on retrospectively collected data, for characterization of patients with symptomatic gallstone disease as regards presence of CBDS, and to compare clinical, ultrasonographic, and DF characterization. DESIGN: Prospective registration of CBDS criteria in consecutive patients with symptomatic gallstone disease. SETTING: A department of surgical gastroenterology in a Norwegian central hospital. PATIENTS: One hundred ninety-two patients with gallbladder stones. INTERVENTION: Laparoscopic cholecystectomy or ERCP with or without endoscopic sphincterotomy. MAIN OUTCOME MEASUREMENTS: Sensitivity and specificity of the clinical, ultrasonographic, and DF characterizations, and test of the validity of the DF. RESULTS: Thirty-two patients had CBDS. The clinical criteria of CBDS were present in 152 patients (79.2%): 21.1% of these patients had CBDS and there were no false-negative results (sensitivity, 100%; specificity, 25%). The risk of CBDS in patients with normal bile ducts at ultrasonographic examination was 8 of 124, and in patients with dilated ducts or suspected CBDS, 17 of 47 (sensitivity, 68%; specificity, 80%). The DF was positive in 50 patients (26%): 60% of these had CBDS, and there were 2 false-negative results (sensitivity, 94%; specificity, 88%). A discriminant analysis of the prospectively registered data selected the same set of CBDS criteria, and a new DF did not alter the characterization of any patient. CONCLUSIONS: Clinical characterization had a higher sensitivity for CBDS detection than ultrasonography alone, but a lower specificity. The DF analysis was both more sensitive and specific than ultrasonography, and seemed efficient in selecting symptomatic gallstone patients for ERCP. It was reproducible and simple to use.

[Laparoscopic colorectal surgery. The first experiences from the Central Hospital of Akershus]. / Laparoskopisk kolorektalkirurgi. De første erfaringene fra Sentralsykehuset i Akershus.

Between November 1993 and August 1997, 49 patients (29 women and 20 men) were selected to 51 laparoscopic and laparoscopic-assisted colonic or rectal operations. Five operations were converted to open surgery because of technical problems and adhesions. 46 operations could be performed as planned. The median age was 67 years (20-88 years). A variety of procedures were carried out, including construction of deviating sigmoideostomas without resection (n = 17), segmental resections of colon (n = 15), rectopexi (n = 6), stoma closure (n = 4), abdominoperineal resection (n = 3) and suture of an iatrogenic perforation of the large bowel (n = 1). Eight of the patients with a bowel resection had carcinoma. The median duration of the procedures was 112 minutes (38-293 minutes) and the length of hospitalisation eight days (2-40 days). 13 patients (28%) developed complications. One of these patients died and four were reoperated. These first experiences show that we are able to perform a variety of colorectal surgery laparoscopically. An experienced, well organised operating team with modern laparoscopic equipment is essential to this type of surgery. Prospective, randomised studies have to be done to assess the efficacy of the laparoscopic approach.

Evaluation of enoxaparin given before and after operation to prevent venous thromboembolism during digestive surgery: play-the-winner designed study.

A total of 316 patients were included in a play-the-winner (PTW) designed study comparing the safety of enoxaparin started preoperatively versus postoperatively as prophylaxis against venous thromboembolism for digestive surgery. In a PTW-designed study the treatment of any next patient depends on the outcome of the previous patient. If successful, the next patient receives the same treatment, if not, the comparative regimen is given. Excessive bleeding according to specified criteria, severe adverse reactions, clinically detected deep venous thrombosis (DVT), or pulmonary embolism (PE) were criteria for classification as "loser." The PTW design allocates most patients to the superior treatment. The main variable in PTW studies is the number of consecutive patients receiving the same treatment. In this study 163 patients were allocated to postoperatively started and 153 to preoperatively started prophylaxis with enoxaparin. The frequency of "winners" was found to be 82.8% and 78.4% in the post- and preoperatively treated groups, respectively. No significant differences were found between the groups with regard to frequency of "winners" or the number of consecutive patients before change of treatment. The percentile of survival distribution did not detect superiority of any group. Prophylaxis against postoperative venous thromboembolism for digestive surgery using enoxaparin can safely be started preoperatively.

Randomized controlled trial with sequential design of laparoscopic versus conventional appendicectomy.

BACKGROUND: A prospective study including 272 patients with suspected appendicitis was performed. The aims were to evaluate the representativity of the study group and to compare diagnostic and therapeutic laparoscopy with conventional appendicectomy. METHODS: The study was an open, randomized, single-centre trial with sequential design. One hundred and eight patients were randomized between laparoscopy or conventional appendicectomy, of whom 84 had acute appendicitis. Duration of postoperative convalescence was the major endpoint. RESULTS: The study patients were representative of the eligible population regarding age and stage of appendicitis. The risk of unnecessary appendicectomy was significantly (P = 0.03) lower after laparoscopy. The mean difference in duration of postoperative convalescence was 4.7 days in favour of of laparoscopic appendicectomy (P = 0.07), and 26 min in duration of operation in favour of conventional appendicectomy (P < 0.01). No differences were detected in postoperative hospital stay, pain assessment or complications. CONCLUSION: The laparoscopic procedure is at least as good as conventional appendicectomy. Initial laparoscopy reduces the rate of misdiagnosis.

Characterization of 'winners' to enoxaparin in the prevention of postoperative venous thromboembolism in digestive surgery.

BACKGROUND: A total of 826 patients were included in three 'play-the-winner' studies to investigate the safety of prophylaxis against venous thromboembolism in digestive surgery. To characterize patients benefiting from prophylaxis with low-molecular heparin, the 445 patients allocated to enoxaparin were investigated. METHODS: A training set consisting of 292 patients from 2 of the studies was analysed by using a linear discriminant model. The reliability of the results was verified on a test set consisting of 153 patients from the third study. RESULTS: A typical 'winner' was a young patient, preferably female, with serum bilirubin in the lower normal range, combined with body temperature, serum sodium, creatinine, and albumin in the upper normal ranges. By using the discriminant function on the test set, 81.7% of the 'winners' and 21.1% of the "losers' were correctly classified. CONCLUSION: The discriminant function for characterization of winners to enoxaparin was found adequate. No rule was acceptable for characterization of losers.

Selection criteria for endoscopic retrograde cholangiopancreaticography (ERCP) in patients with gallstone disease.

Endoscopic retrograde cholangiopancreatography (ERCP) has been used in patients referred to cholecystectomy when clinical information, biochemical values, or ultrasonography (clinical characterization) have indicated possible presence of common bile duct stones. A retrospective study of 599 patients treated for gallstone disease was used to develop a characterization procedure for predicting common bile duct stones by a discriminant analysis procedure. The variables selected by the analysis as the best combination for CBDS prediction were age (years), the values of bilirubin (micromol/l), ALAT (U/l) and gamma GT (U/l). The characterization was false positive in 22 cases (3.7%) and false negative in 11 cases (1.8%), compared to 198 false positive cases (33.1%) and three false negative cases (0.5%) by the clinical characterization. A leaving-one-out correction did not change the results. In a test set of 157 cholecystectomy patients, clinical characterization was false positive in 44.6% of the patients, compared to 4.5% false positive results when using the discriminant analysis procedure. The discriminant analysis procedure would have missed one patient with common bile duct stones. Selection by the discriminant analysis characterization procedure seems to reduce the frequency of preoperative ERCP significantly without an increase in undetected common bile duct stones.

Comparison of sequential and fixed-sample designs in a controlled clinical trial with laparoscopic versus conventional cholecystectomy.

BACKGROUND: The aim of this study was to compare a fixed-sample and a sequential design with regard to study duration, sample size, and medical results in a real-life situation. METHODS: A randomized study comparing laparoscopic and conventional cholecystectomy was carried out with a fixed-sample design, parallel with a sequential design. The main variable was duration of postoperative convalescence. RESULTS: In the fixed-sample trial the necessary number of patients was calculated to be 72. The sequential trial was conclusive after inclusion of 24 patients and reduced the duration of the study from 43 to 18 weeks. Additionally, the sequential trial reached the same conclusions as the fixed-sample trial in all the observed variables except for one. CONCLUSION: The present study indicates that sequential design should be used more frequently in clinical trials, to involve the smallest possible number of patients necessary to reach a conclusion.

Prospective nonrandomized study of conventional versus laparoscopic appendectomy.

With the introduction of laparoscopic appendectomy a prospective study was started. Patients with suspected appendicitis were selected for conventional appendectomy or laparoscopy according to the preference of the surgeon on call. During a 1-year period 233 patients were included, of whom 97 underwent conventional appendectomy and 136 laparoscopy. Among the patients selected to laparoscopy, laparoscopic appendectomy was carried out in 72 cases, conventional appendectomy in 32, and only diagnostic laparoscopy in the remaining 32. Removal of a normal appendix was significantly more common in the group of patients directly selected for conventional appendectomy compared to laparoscopy (p < 0.01). The duration of the operation was shorter (p < 0.05) and the postoperative hospital stay and the convalescence longer (p < 0.05) with conventional than with laparoscopic appendectomy. Peroperative problems and minor postoperative complications were more common (p < 0.01) with laparoscopic than conventional appendectomy. However, the clinical impact of these problems were limited. The difference between the procedures regarding major complications was not significant. Laparoscopic appendectomy seems to be at least as good as conventional appendectomy. However, randomized controlled trials are needed to decide which of the procedures to recommend.

Safety of enoxaparin and dextran-70 in the prevention of venous thromboembolism in digestive surgery. A play-the-winner-designed study.

A total of 327 patients were included in a play-the-winner (PTW)-designed study comparing the safety of prophylaxis with enoxaparin and dextran-70 in patients undergoing digestive surgery. In a PTW-designed study the treatment of any next patient will depend on the outcome of the previous one. If successful, the next patient will receive the same treatment. Excessive bleeding, on the basis of specified criteria, severe adverse effects, or occurrence of clinically detected venous thromboembolism was classified as failure. The PTW design allocates most patients to the superior treatment. In this study 200 patients were given enoxaparin and 127 dextran-70. The success rate was 83% in the enoxaparin group and 74.8% in the dextran-70 group (p = 0.05). The survival analysis of 'Number of patients before change in treatment' shows a significant difference in favour of enoxaparin (p = 0.05). Enoxaparin seems to be superior to dextran-70 as a prophylaxis in digestive surgery. The PTW model is a suitable design in such studies.

Laparoscopic and open cholecystectomy. A prospective, randomized study.

OBJECTIVE: To compare laparoscopic with open cholecystectomy. DESIGN: Prospective random control trial. SETTING: Central Hospital of Akershus, Nordbyhagen, Norway. SUBJECTS: 74 consecutive patients due to undergo elective cholecystecomy between October 1990 and June 1991. INTERVENTIONS: Two patients were excluded from randomisation, and two were withdrawn after randomisation. The remaining 70 were randomly allocated to open or laparoscopic cholecystectomy (n = 35 in each group). MAIN OUTCOME MEASURES: Duration of operation and postoperative stay in hospital, amount of postoperative pain, incidence of complications, and duration of convalescence and sick leave. RESULTS: Laparoscopic cholecystectomy took twice as long as open (median [range] 100 [52-180] minutes compared with 50 [15-115], p < 0.01), but patients stayed in hospital half the time (2 [1-9] days compared with 4 [2-22], p < 0.01); required less opiate analgesia (4 [0-20] doses compared with 6 [0-13], p = 0.02; took less sick leave (11 [4-267] days (n = 18) compared with 34 [20-48] (n = 22), p < 0.01); and spent less time in convalescence (8 [3-40] days (n = 17) compared with 49 [10-247] (n = 12), p < 0.01). There were six complications in the laparoscopy group and seven in the open cholecystectomy group. CONCLUSION: Because of the significant differences between laparoscopic and open cholecystectomy we have now adopted the laparoscopic method as our standard, but we think that we can improve our results further by refining our operative techniques and giving our patients more information.

[Gastroenterological surgical procedures using a flexible scope]. / Gastroenterologisk operativ virksomhet gjennom fleksible skop.

The past decade has witnessed revolutionary developments in the applications of operative endoscopy, and many new techniques have replaced conventional surgical procedures. With the modern flexible instruments available for gastro-intestinal endoscopy, it is possible to reach the oesophagus, stomach, duodenum, colon and ileum. The range of treatment options has been successively broadened by the combination of endoscopy with such procedures as diathermy, laser, electrohydraulic shock waves and ultrasonography.