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Biomedical subjects

H G Gooszen

Publications and source records attributed to H G Gooszen.

At least 19 recordsLinked to original sources
PubMed2006

Small-incision versus open cholecystectomy for patients with symptomatic cholecystolithiasis.

BACKGROUND: Cholecystectomy is one of the most frequently performed operations. Open cholecystectomy has been the gold standard for over 100 years. Small-incision cholecystectomy is a less frequently used alternative. OBJECTIVES: To compare the beneficial and harmful effects of small-incision versus open cholecystectomy for patients with symptomatic cholecystolithiasis. SEARCH STRATEGY: We searched TheCochrane Hepato-Biliary Group Controlled Trials Register (6 April 2004), The Cochrane Library (Issue 1, 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), Web of Science (1988 to January 2004), and CINAHL (1982 to January 2004) for randomised trials. SELECTION CRITERIA: All published and unpublished randomised trials in patients with symptomatic cholecystolithiasis comparing any kind of small-incision or other kind of minimal incision cholecystectomy versus any kind of open cholecystectomy. No language limitations were applied. DATA COLLECTION AND ANALYSIS: Two authors independently performed selection of trials and data extraction. The methodological quality of the generation of the allocation sequence, allocation concealment, blinding, and follow-up was evaluated to assess bias risk. Analyses were based on the intention-to-treat principle. Authors were requested additional information in case of missing data. Sensitivity and subgroup analyses were performed if appropriate. MAIN RESULTS: Seven trials randomised 571 patients. Bias risk was high in the included trials. No mortality was reported. The total complication proportions are respectively 9.9% and 9.3% in the small-incision and open group, which is not significantly different (risk difference all trials, random-effects 0.00, 95% confidence interval (CI) -0.06 to 0.07). There are also no significant differences considering severe complications and bile duct injuries. However, small-incision cholecystectomy has a shorter hospital stay (weighted mean difference, random-effects -2.8 days (95% CI -4.9 to -0.6)) compared to open cholecystectomy. AUTHORS' CONCLUSIONS: Small-incision and open cholecystectomy seem to be equivalent regarding risks of complications, but the latter method is associated with a significantly longer hospital stay. The quicker recovery of small-incision cholecystectomy compared with open cholecystectomy confirms the existing preference of this technique over open cholecystectomy.

Cholecystectomy↗
PubMed2006

Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis.

BACKGROUND: Cholecystectomy is one of the most frequently performed operations. Open cholecystectomy has been the gold standard for over 100 years. Small-incision cholecystectomy is a less frequently used alternative. Laparoscopic cholecystectomy was introduced in the 1980s. OBJECTIVES: To compare the beneficial and harmful effects of laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. SEARCH STRATEGY: We searched TheCochrane Hepato-Biliary Group Controlled Trials Register (6 April 2004), The Cochrane Library (Issue 1, 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), Web of Science (1988 to January 2004), and CINAHL (1982 to January 2004) for randomised trials. SELECTION CRITERIA: All published and unpublished randomised trials in patients with symptomatic cholecystolithiasis comparing any kind of laparoscopic cholecystectomy versus small-incision or other kind of minimal incision open cholecystectomy. No language limitations were applied. DATA COLLECTION AND ANALYSIS: Two authors independently performed selection of trials and data extraction. The methodological quality of the generation of the allocation sequence, allocation concealment, blinding, and follow-up was evaluated to assess bias risk. Analyses were based on the intention-to-treat principle. Authors were requested additional information in case of missing data. Sensitivity and subgroup analyses were performed if appropriate. MAIN RESULTS: Thirteen trials randomised 2337 patients. Methodological quality was relatively high considering the four quality criteria. Total complications of laparoscopic and small-incision cholecystectomy are high: 26.6% versus 22.9%. Total complications (risk difference, random-effects -0.01, 95% confidence interval (CI) -0.07 to 0.05), hospital stay (weighted mean difference (WMD), random-effects -0.72 days, 95% CI -1.48 to 0.04), and convalescence were not significantly different. High-quality trials show a quicker operative time for small-incision cholecystectomy (WMD, high-quality trials 'blinding', random-effects 16.4 minutes, 95% CI 8.9 to 23.8) while low-quality trials show no significant difference. AUTHORS' CONCLUSIONS: Laparoscopic and small-incision cholecystectomy seem to be equivalent. No differences could be observed in mortality, complications, and postoperative recovery. Small-incision cholecystectomy has a significantly shorter operative time. Complications in elective cholecystectomy are prevalent.

Cholecystectomy↗
PubMed2006

Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis.

BACKGROUND: Cholecystectomy is one of the most frequently performed operations. Open cholecystectomy has been the gold standard for over 100 years. Laparoscopic cholecystectomy was introduced in the 1980s. OBJECTIVES: To compare the beneficial and harmful effects of laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. SEARCH STRATEGY: We searched TheCochrane Hepato-Biliary Group Controlled Trials Register (April 2004), The Cochrane Library (Issue 1, 2004), MEDLINE (1966 to January 2004), EMBASE (1980 to January 2004), Web of Science (1988 to January 2004), and CINAHL (1982 to January 2004) for randomised trials. SELECTION CRITERIA: All published and unpublished randomised trials in patients with symptomatic cholecystolithiasis comparing any kind of laparoscopic cholecystectomy versus any kind of open cholecystectomy. No language limitations were applied. DATA COLLECTION AND ANALYSIS: Two authors independently performed selection of trials and data extraction. The methodological quality of the generation of the allocation sequence, allocation concealment, blinding, and follow-up was evaluated to assess bias risk. Analyses were based on the intention-to-treat principle. Authors were requested additional information in case of missing data. Sensitivity and subgroup analyses were performed when appropriate. MAIN RESULTS: Thirty-eight trials randomised 2338 patients. Most of the trials had high bias risk. There was no significant difference regarding mortality (risk difference 0,00, 95% confidence interval (CI) -0.01 to 0.01). Meta-analysis of all trials suggests less overall complications in the laparoscopic group, but the high-quality trials show no significant difference ('allocation concealment' high-quality trials risk difference, random effects -0.01, 95% CI -0.05 to 0.02). Laparoscopic cholecystectomy patients have a shorter hospital stay (weighted mean difference (WMD), random effects -3 days, 95% CI -3.9 to -2.3) and convalescence (WMD, random effects -22.5 days, 95% CI -36.9 to -8.1) compared to open cholecystectomy. AUTHORS' CONCLUSIONS: No significant differences were observed in mortality, complications and operative time between laparoscopic and open cholecystectomy. Laparoscopic cholecystectomy is associated with a significantly shorter hospital stay and a quicker convalescence compared with the classical open cholecystectomy. These results confirm the existing preference for the laparoscopic cholecystectomy over open cholecystectomy.

Cholecystectomy↗
PubMed2006

[A nationwide Dutch study into the optimal treatment of patients with infected necrotising pancreatitis: the PANTER trial].

Surgical intervention in infected necrotising pancreatitis generally consists of necrosectomy via laparotomy. The morbidity and mortality after this procedure might be reduced by minimally invasive strategies. The 20 hospitals of the Dutch Acute Pancreatitis Study Group are currently enrolling patients in a randomised trial to compare (a) laparotomy with necrosectomy and continuous postoperative lavage with (b) CT-guided or endoscopic transgastric drainage, if necessary, followed by videoscopic assisted retroperitoneal debridement (VARD): the PANTER trial ('pancreatitis, necrosectomy versus a minimally invasive step-up approach'). The primary endpoint is the proportion of patients suffering from major postoperative morbidity and mortality. Patients with (suspected) infected necrotising pancreatitis can be put forward for participation in the trial in one of the 20 participating centres.

Debridement↗
PubMed2006

Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial.

BACKGROUND: Endoscopic treatment for gastro-oesophageal reflux disease (GORD) is rapidly emerging, but there is a great need for randomised controlled trials to evaluate the efficacy. DESIGN AND SETTING: A single-centre, double-blind, randomised, sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system. PATIENTS AND INTERVENTIONS: 60 patients with GORD were randomly assigned to three endoscopic gastroplications (n = 20), a sham procedure (n = 20) or observation (n = 20). The research nurse and patients in the active and sham groups were blinded to the procedure assignment. After 3 months, open-label active treatment was offered to all patients. OUTCOME MEASURES: The primary outcome measures were proton pump inhibitor (PPI) use and GORD symptoms, and secondary measures were quality of life, 24-h oesophageal acid exposure, oesophageal manometry and adverse events. Follow-up assessments were performed at 3, 6 and 12 months. RESULTS: At 3 months, the percentage of patients who had reduced drug use by > or =50% was greater in the active treatment group (65%) than in the sham (25%) or observation groups (0%) (p<0.02). Symptoms (heartburn and to a lesser extent regurgitation) improved more in the active group than in the sham group. Three Short Form-20 quality of life subscales (role function, general health and bodily pain perception) improved in the active group versus sham. Oesophageal acid exposure was modestly decreased after active treatment (p<0.02), but not significantly greater than after the sham procedure (p = 0.61). The active treatment effects on PPI use, symptoms and quality of life persisted after 6 and 12 months of open-label follow-up (n = 41), but 29% of patients were retreated in this period. No serious adverse events occurred. CONCLUSIONS: Endoscopic gastroplication, using the Endocinch device, reduced acid-inhibitory drug use, improved GORD symptoms and improved the quality of life at 3 months compared with a sham procedure. The effects persisted up to 12 months. However, the reduction in oesophageal acid exposure was not greater after endoscopic treatment than after a sham procedure.

Antacids↗
PubMed2006

[Potential role for probiotics in the prevention of infectious complications during acute pancreatitis].

Acute pancreatitis has a high mortality in case of secondary infection of (peri-)pancreatic necrosis. Bacterial translocation is held responsible for the majority of these infectious complications of severe acute pancreatitis. Prophylactic strategies should therefore be directed at the three most important pathophysiological mechanisms of bacterial translocation: disturbed small-bowel motility and bacterial overgrowth, failure of the mucosal barrier function and a disturbed response of the immune system. In-vitro studies and research in experimental animals have shown that specially selected probiotics exert an effect on these mechanisms and can prevent bacterial translocation. Recently, several randomised, double-blind, placebo-controlled trials evaluating prophylactic treatment with enteral probiotics have shown good results. A Dutch multicentre trial, 'Probiotics in pancreatitis trial' (PROPATRIA), is currently underway.

Bacterial Translocation↗
PubMed2006

Surgical intervention in patients with necrotizing pancreatitis.

BACKGROUND: This study evaluated the various surgical strategies for treatment of (suspected) infected necrotizing pancreatitis (INP) and patient referrals for this condition in the Netherlands. METHODS: This retrospective study included all 106 consecutive patients who had surgical treatment for INP in the period 2000-2003 in one of eight Dutch university medical centres including three teaching hospitals. Surgical approaches included an open abdomen strategy, laparotomy with continuous postoperative lavage, minimally invasive procedures or laparotomy with primary abdominal closure. The National Hospital Registration System was searched to identify patients with acute pancreatitis who were admitted to the 90 Dutch hospitals that did not participate in the present study. RESULTS: The overall mortality rate was 34.0 per cent, 70 per cent (16 of 23) for the open abdomen strategy, 25 per cent (13 of 53) for continuous peritoneal lavage, 11 per cent (two of 18) for minimally invasive procedures and 42 per cent (five of 12) for primary abdominal closure (P < 0.001). During the study interval, 44 (12.2 per cent) of 362 patients with acute pancreatitis who were likely to require surgical intervention had been referred to university medical centres. CONCLUSION: Laparotomy with continuous postoperative lavage is the surgical strategy most often used in the Netherlands. The results of the open abdomen strategy are poor whereas a minimally invasive approach seems promising.

Adult↗
PubMed2006

Randomized clinical trial and follow-up study of cost-effectiveness of laparoscopic versus conventional Nissen fundoplication.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) has essentially replaced its conventional open counterpart (CNF). An economic evaluation of LNF compared with CNF based on prospective data with adequate follow-up is lacking. METHODS: Data from two consecutive studies (a randomized clinical trial (RCT) of 57 patients undergoing LNF and 46 undergoing CNF that was terminated prematurely, and a follow-up study of 121 consecutive patients with LNF) were combined to determine incremental cost-effectiveness 1 year after surgery. RESULTS: Mean operating time, reoperation rate and hospital costs of LNF were lower in the second series. The mean overall hospital cost per patient was euro 9126 for LNF and euro 6989 for CNF at 1 year in the initial RCT, and euro 7782 in the second LNF series. The success rate of both LNF and CNF at 1 year was 91 per cent in the RCT, and LNF was successful in 90.1 per cent in the second series. A cost reduction of euro 998 for LNF would cancel out the cost advantage of CNF. Similarly, if the reoperation rate after LNF decreased from 0.05 to below 0.008 and/or if the mean duration of sick leave after LNF was reduced from 67.2 to less than 61.1 days, the procedure would become less expensive than CNF. Complications, reoperation rate and quality of life after both operations were similar. CONCLUSION: Including reinterventions, the outcome at 1 year after LNF and CNF was similar. In a well organized setting with appropriate expertise, the cost advantage of CNF may be neutralized.

Adult↗
PubMed2006

Randomized clinical trial of standard laparoscopic versus robot-assisted laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease.

BACKGROUND: Robotic systems for minimally invasive surgery may be of added value during extensive dissection and suturing in confined spaces, such as laparoscopic Nissen fundoplication (LNF). The purpose of this trial was to compare standard LNF with robot-assisted Nissen fundoplication (RNF). METHODS: Between 2003 and 2005, 50 patients with confirmed refractory gastro-oesophageal reflux disease were assigned to LNF (25) or RNF (25). Patients who had undergone previous antireflux surgery were excluded. Independent assessment of dysphagia, regurgitation, heartburn and general well-being was performed before and 6 months after surgery using questionnaires. Objective outcome was studied 6 months after surgery by oesophageal manometry, 24-h pH monitoring, barium oesophagram series and upper endoscopy. RESULTS: Operating time, blood loss, postoperative pain scores, hospital stay and complication rates did not differ significantly between the two groups. Reoperation rates were the same (one incisional hernia after LNF and one patient with repeat Nissen after RNF because of persistent dysphagia). Postoperative self-rated change in reflux symptoms and quality of life improved equally in both groups. The reduction in oesophageal acid exposure, increase in lower oesophageal sphincter tone and mucosal healing were comparable in both groups at follow-up. CONCLUSION: RNF yielded similar subjective and objective results to LNF in this study. Therefore no additive value of robotic systems for this procedure was detected up to 6 months after surgery.

Adult↗
PubMed2006

Buttressing of the staple line in gastrointestinal anastomoses: overview of new technology designed to reduce perioperative complications.

BACKGROUND: Mechanical stapling devices are widely used in all fields of surgery as they can cut and sew tissue in a quick and easy manner. However, complications like bleeding or leakage at the staple line are frequently encountered and can have devastating consequences. Recent developments have led to the introduction of staple line reinforcement to reduce these complications. METHODS: The literature has been reviewed to find and describe different methods to improve stapled resections and to give an extensive overview of the different staple line reinforcement materials, their properties and indications. RESULTS: Several types of staple line reinforcement are available. Reinforcement of the staple line with membranes of either non-, semi- or absorbable material seems to be effective in minimizing the risk of leakage and bleeding by providing strength to the cut tissue. CONCLUSION: Application of staple line reinforcement material seems a promising technique in preventing leakage and bleeding at the stapled suture line, thus potentially reducing complications of gastrointestinal surgery. More studies are needed to investigate the exact properties, behavior and effects of the staple line reinforcement material.

Animals↗
PubMed2006

Effect of laparoscopic gastric banding on esophageal motility.

BACKGROUND: Alterations in esophageal motility may occur after placement of an adjustable gastric band as treatment for morbid obesity, near the gastro-esophageal junction. It causes an outlet obstruction, especially during follow-up after the band is filled. METHODS: 29 morbidly obese patients underwent conventional manometry preoperatively, 6 weeks postoperatively before and after filling the band and at 6 months postoperatively. A questionnaire was used to assess upper gastrointestinal symptoms during follow-up. RESULTS: After band placement, there was a significant increase in lower esophageal sphincter (LES) end-expiratory pressure at 6 weeks with an empty band: 1.3 (0.9-1.9) kPa (median (interquartile range) (P=0.003), 6 weeks with a filled band: 2.1 (1.5-2.8) kPa (P=0.0001), and at 6 months: 1.5 (1.3-1.9) kPa (P=0.001), compared to the preoperative pressure: 0.8 (0.6-1.3) kPa. Also after band placement, the high pressure zone length increased (preop 5.0 (4.3-6.0) cm vs 6 weeks 6.0 (5.0-6.5) cm (P=0.003). The propagation of peristaltic contractions was not significantly altered after band placement. Heartburn decreased 6 weeks postoperatively (P=0.04) but increased at 6 months. Heartburn at 6 months was correlated with pouch formation (0.667; P<0.01). CONCLUSION: Adjustable gastric band placement causes an increase in LES pressure and length of the high pressure zone. It decreases reflux symptoms in the short-term, but this effect appears not to be related to an effect on LES pressure or length. Pouch formation increases reflux symptoms without having any relationship to LES pressure and length. Band placement in the short-term does not disturb propagation of esophageal contractions.

Adult↗
PubMed2005

Controversies in paraesophageal hernia repair: a review of literature.

BACKGROUND: The surgical repair of paraesophageal hiatal hernias (PHH) can be performed by endoscopic means, but the procedure is not standardized and results have not been evaluated systematically so far. The aim of this review article was to clarify controversial subjects on the surgical approach and technique, i.e., recurrence rate after conventional versus laparoscopic PHH treatment, results of mesh reinforcement of the cruroplasty, the necessity for additional antireflux surgery, and indications for an esophageal lengthening procedure. METHODS: An electronic Medline search was performed to identify all publications reporting on laparoscopic and conventional PHH surgery. The computer search was followed by additional hand searches in books, journals, and related articles. All types of publications were evaluated because of a lack of high-level evidence studies such as randomized controlled trials. Critical analysis followed for all articles describing a study population of >10 patients and those reporting postoperative outcome. RESULTS: A total of 32 publications were reviewed. Randomized controlled trials comparing laparoscopic and open techniques could not be identified. Nineteen of the publications described the results of retrospective series. Therefore, most of the studies retrieved were low in hierarchy of evidence (level II-c or lower). The overall median hospital time as published was 3 days for patients operated laparoscopically and 10 days in the conventional group. Postoperative complications, such as pneumonia, thrombosis, hemorrhage, and urinary and wound tract infections, appeared to be more frequent after conventional surgery. Follow-up was longer for conventional surgery (median 45 months versus 17.5 months after the laparoscopic technique). Recurrence rates reported were higher in patients operated conventionally (median 9.1% versus 7.0% for patients operated laparoscopically). Recurrences after PHH repair may decrease with usage of mesh in the hiatus, although uniform criteria for this procedure are lacking. No conclusions could be drawn regarding the necessity for an additional antireflux procedure. Furthermore, uniform specific indications for the need of an esophageal lengthening procedure or preoperative assessment methods for shortened esophagus could not be detected. CONCLUSION: Treatment based on standardized protocols for preoperative assessment and postoperative follow-up is required to clarify the current controversies.

Hernia, Hiatal↗
PubMed2005

[Timing and choice of intervention in necrotising pancreatitis].

Three patients, men aged 49, 62 and 33 years, were admitted with acute abdominal symptoms due to necrotising pancreatitis. They underwent multiple interventions during a hospital stay of several months, but ultimately recovered completely. In case of infected (peri-)pancreatic necrosis, intervention is required. Good clinical judgement in the differentiation between the septic inflammatory-response syndrome, sepsis and infected necrosis as the cause of the clinical condition is important. Because of the different intervention strategies, treatment by a team comprising a radiologist, gastroenterologist, intensive care specialist and gastrointestinal surgeon is required. Randomised studies on intervention in infected pancreatic necrosis are lacking. In 2002, to improve the treatment of patients with acute (necrotising) pancreatitis via a combination of research, consultation and centralisation, the Dutch Acute Pancreatitis Study Group was formed.

Adult↗
PubMed2005

The ileo neo rectal anastomosis (INRA) in patients with familial adenomatous polyposis: clinical results at two years.

BACKGROUND: Ileo neo rectal anastomosis (INRA) is a promising alternative for patients with familial adenomatous polyposis (FAP) to restorative proctocolectomy with its morbidity and unpredictable functional outcome to colectomy with ileo rectal anastomosis (IRA) with the continuing risk of rectal cancer. The aims of the present study were to evaluate the function of the neorectum, to assess the morbidity and complications of the operation and to determine the incidence of neorectal polyps. METHODS: Data of all patients having INRA, including bowel function and complications, were prospectively recorded. The reservoir capacity was determined repeatedly by physiologic tests. The anal sphincter complex was assessed by manometry and ultrasound examination. Evaluation of the neorectal mucosa was performed by endoscopy. RESULTS: Six patients underwent the INRA procedure for FAP. Median defaecation frequency two years postoperatively was 5.5/24 h (range 4-7) including 1/night (range 0-2). Endoscopic examination showed normal mucosa and no evidence of polyp formation in all patients. CONCLUSION: INRA affords a good functional reservoir and is accompanied by few reservoir-related complications. At a minimum follow up period of two years, no growth of polyps in the neorectum occurred.

Adenoma↗
PubMed2005

Impaired bolus transit across the esophagogastric junction in postfundoplication dysphagia.

OBJECTIVES: This study assessed the effect of fundoplication on liquid and solid bolus transit across the esophagogastric junction (EGJ) in relation to EGJ dynamics and dysphagia. METHODS: Twelve patients with gastro-esophageal reflux disease (GERD) were studied before and after fundoplication. Concurrent high-resolution EGJ manometry and fluoroscopy were performed whilst swallowing liquid barium and a solid bolus. The EGJ transit time, EGJ opening duration, transit efficacy, and EGJ relaxation were measured. During the test symptoms of dysphagia were scored using a visual analog scale. RESULTS: The minimal opening aperture at fluoroscopy was located at the manometric EGJ in all subjects. Fundoplication markedly reduced the EGJ opening diameter from 1.0 +/- 0.1 to 0.6 +/- 0.1 cm (p < 0.01) and rendered deglutative EGJ relaxation incomplete. After fundoplication, a higher intrabolus pressure was found (p < 0.05) associated with a reduced axial bolus length (p < 0.001). EGJ transit time increased from 6.9 +/- 0.9 to 9.8 +/- 1.0 s for liquids (p < 0.01) and from 2.8 +/- 0.5 to 5.8 +/- 0.8 s (p < 0.01) for solids after fundoplication. No relation between EGJ transit and dysphagia scores was observed before fundoplication. In contrast, EGJ transit time significantly correlated with dysphagia scores both during liquid (r = 0.84; p < 0.01) and solid (r = 0.69; p < 0.05) bolus transit following fundoplication. CONCLUSIONS: Fundoplication patients exhibit a restricted hiatal opening and an incomplete deglutative EGJ relaxation. To facilitate EGJ transit despite these altered EGJ dynamics a higher intrabolus pressure is created by augmented bolus compression. Fundoplication increases EGJ transit time, the degree of which is associated with postoperative dysphagia.

Adult↗
PubMed2004

Ileo-neorectal anastomosis: medium- and long-term follow-up of 37 patients.

BACKGROUND: Ileo-neorectal anastomosis (INRA), an alternative restorative procedure, was developed to reduce the pouch-related complication rate with an (at least) equal functional result. METHODS: For this surgical outcome, data of all INRA patients, including bowel function and complications, were prospectively recorded. The reservoir capacity was determined repeatedly by physiologic tests. The anal sphincter complex was assessed by manometry and ultrasound examination. Evaluation of the neorectal mucosa was performed by endoscopy. RESULTS: An INRA procedure was carried out in 39/53 selected patients (47 ulcerative colitis and 6 familial adenomatous polyposis). Fourteen UC cases were converted to ileal pouch anal anastomosis or proctectomy only, because of impossibility to completely remove the rectal mucosa or short of length of the rectal stump. The median operation time for INRA was 323 min (range 240-518), with 1,400 ml blood loss (400-4,500). The reservoirs were permanently defunctioned in 2 patients--one because of reclassification into Crohn's disease, and one with pouchitis refractory to medical treatment. In 18 out of 37 cases, web-like stenoses occurred at the mucosa-anal level, which were treated by single (9) or repeated (5) dilatation or surgical stenoplasty (2). No pouch-related complications like pelvic sepsis, fistula or sexual dysfunction occurred. Thirteen patients had episodes of 'pouchitis', successfully treated with antibiotics, and 7 other cases, with functioning reservoirs, also had proximal 'non-specific' (i.e. no histological criteria of Crohn's disease found) small bowel inflammation. The median bowel frequency decreased from 15x/24 h initially to 7x/24 h at 2 years. Continence was perfect in 24/37 cases. Twelve out of 37 cases had occasional nocturnal soiling and passive nocturnal fecal incontinence was reported by 2/37 patients. The neorectal compliance volume recovered from 12.5 ml kPa after subtotal colectomy and 11 ml/kPa at 6 months after INRA to a neorectal compliance of 24 ml/kPa at 2 years' follow-up (p < 0.002; Wilcoxon signed rank test). CONCLUSION: The INRA procedure shows a low complication rate and reasonable functional results, there was however a considerable conversion rate in these first 53 cases and a high incidence of reclassification to CD.

Clinical Competence↗
PubMed2004

[Results of randomised clinical trial: not necessarily positively received].

The acceptance for publication and the implementation of the results of a randomised clinical trial are determined not only by the quality of the study, but also by its timing and the prevailing opinion prior to the study. In a randomised study, comparing laparoscopic and open fundoplication in patients with gastro-oesophageal reflux, interim analysis showed statistically significantly more complications related to laparoscopic intervention. Publication of the study led to an avalanche of criticism focusing mainly on the inexperience of the surgeons. The cost-effectiveness analysis, showing that open fundoplication had fewer complications and was cheaper, was repeatedly rejected by established journals mainly because of criticism of surgical aspects of the study. In the meanwhile a study on a second group of 100 patients was initiated. They underwent laparoscopic fundoplication conducted by two experienced surgeons. The results were statistically significantly better than in the laparoscopic arm of the initial randomised trial. The learning curve proved to be longer than had previously been thought.

Clinical Competence↗