Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials.

BACKGROUND: Surgical interventions are complex, with multiple components that require consideration in trial reporting. This review examines the reporting of details of surgical interventions in randomized clinical trials (RCTs) within the context of explanatory and pragmatic study designs. METHODS: Systematic searches identified RCTs of surgical interventions published in 2010 and 2011. Included studies were categorized as predominantly explanatory or pragmatic. The extent of intervention details in the reports were compared with the CONSORT statement for reporting trials of non-pharmacological treatments (CONSORT-NPT). CONSORT-NPT recommends reporting the descriptions of surgical interventions, whether they were standardized and adhered to (items 4a, 4b and 4c). Reporting of the context of intervention delivery (items 3 and 15) and operator expertise (item 15) were assessed. RESULTS: Of 4541 abstracts and 131 full-text articles, 80 were included (of which 39 were classified as predominantly pragmatic), reporting 160 interventions. Descriptions of 129 interventions (80.6 per cent) were provided. Standardization was mentioned for 47 (29.4 per cent) of the 160 interventions, and 22 articles (28 per cent) reported measurement of adherence to at least one aspect of the intervention. Seventy-one papers (89 per cent) provided some information about context. For one-third of interventions (55, 34.4 per cent), some data were provided regarding the expertise of personnel involved. Reporting standards were similar in trials classified as pragmatic or explanatory. CONCLUSION: The lack of detail in trial reports about surgical interventions creates difficulties in understanding which operations were actually evaluated. Methods for designing and reporting surgical interventions in RCTs, contributing to the quality of the overall study design, are required. This should allow better implementation of trial results into practice.

Postoperative esophageal physiology studies may help to predict long-term symptoms following laparoscopic Nissen fundoplication.

BACKGROUND: Laparoscopic Nissen fundoplication is an established treatment for gastroesophageal reflux disease (GERD). Postoperative improvement in esophageal physiology can be indicative of successful surgery, but the degree to which it correlates with symptom control remains questionable. We have performed this study to assess the utility of postoperative esophageal physiology studies in predicting long-term symptomatic outcome. METHODS: Between August 1997 and August 2003, 145 patients with symptomatic GERD underwent laparoscopic Nissen fundoplication as part of a randomized trial. Four months after surgery patients were invited to have postoperative esophageal physiology studies. In November 2005, a postal questionnaire was sent to all patients in order to assess reflux symptomatology (DeMeester symptom score). RESULTS: Completed symptom questionnaires were returned by 108 patients (74%) after a median of 5.7 years postoperatively. Linear regression of manometry data showed a significant correlation between the level of postoperative neosphincter pressure either above or below the median and long-term scores for heartburn (p = 0.03), dysphagia (p = 0.02), regurgitation (p = 0.01), and total symptom score (p = 0.002). In contrast, there was no evidence of a significant correlation between results of postoperative esophageal pH studies and symptom scores. CONCLUSION: Postoperative physiology studies, particularly manometry, may be predictive of long-term symptoms following laparoscopic Nissen fundoplication.

Who should perform laparoscopic cholecystectomy? A 10-year audit.

BACKGROUND: Laparoscopic cholecystectomy is one of the most common operations in general surgery. It is performed by surgeons with a specialist interest in biliary disease as well as by surgeons with other specialist interests. METHODS: This retrospective audit of all cholecystectomies was conducted in a single hospital over a 10-year period from 1996 to 2005. Data were extracted from two independent electronic databases and supplemented by a full note review of cases with extended postoperative stay or unplanned readmission. The outcomes for cases under the care of specialist upper gastrointestinal (GI) consultants were compared with outcomes for cases of general surgery consultants from other firms. RESULTS: Data from 4,139 cholecystectomies were obtained. More cholecystectomies performed by upper GI firms were completed laparoscopically (96.2% vs 80.1%) with a higher rate of intraoperative cholangiograms (83.4% vs 16.9%). The mean operating time was shorter for upper GI cases (69 vs 84 min), as was the postoperative hospital stay (2 vs 3.6 days). There also was a significantly lower incidence of bile duct injury in upper GI cases (0.1% vs 0.9%). CONCLUSION: In their institution, the authors found evidence of improved outcomes when laparoscopic cholecystectomy was performed under the care of surgeons with a specialist interest in upper GI or hepatopancreaticobiliary surgery.

Does open surgery continue to have a role in elective splenectomy?

BACKGROUND: Since it was first reported in 1991, laparoscopic splenectomy has become the procedure of choice for elective splenectomy. However, doubts have been raised regarding the suitability of patients with splenomegaly (>1 kg) for laparoscopic resection because there have been reports of greater morbidity and higher conversion rates in this group of patients. Since 2000, patients referred to the authors' center for splenectomy with an estimated spleen weight exceeding 1 kg have undergone splenectomy by the open approach. METHODS: Between September 1995 and April 2005, 95 elective splenectomies were performed by a single surgeon. Operative data were collected prospectively. RESULTS: A comparison between the operations that took place before 2001 (n = 47) and those performed after 2000 (n = 48) for all sizes of spleen showed significant reductions in conversion rate, operative time, and hospital stay in the later group. As compared with laparoscopic splenectomy (n = 11), open splenectomy (n = 18) for cases of splenomegaly resulted in a significantly shorter operative time, less operative blood loss, and no significant difference in hospital stay. CONCLUSION: Although laparoscopic splenectomy is the treatment of choice for the majority of patients requiring elective splenectomy, the procedure for patients with significant splenomegaly requires caution and common sense. This study shows that an open splenectomy for these patients significantly reduces operative time and blood loss without increasing morbidity or hospital stay.