Objective: The aim of this study was to establish whether surgical or conservative treatment leads to a higher quality of life (QoL) in patients with recurring diverticulitis and/or ongoing complaints. Summary of Background Data: The 6 months’ results of the DIRECT trial, a randomized trial comparing elective sigmoidectomy with conservative management in patients with recurring diverticulitis (>2 episodes within 2 years) and/or ongoing complaints (>3 months) after an episode of diverticulitis, demonstrated a significantly higher QoL after elective sigmoidectomy. The aim of the present study was to evaluate QoL at 5-year follow-up. Methods: From January 2010 to June 2014, 109 patients were randomized to either elective sigmoidectomy (N = 53) or conservative management (N = 56). In the present study, the primary outcome was QoL measured by the Gastrointestinal Quality of Life Index (GIQLI) at 5-year follow-up. Secondary outcome measures were SF-36 score, Visual Analogue Score (VAS) pain score, EuroQol-5D-3L (EQ-5D-3L) score, morbidity, mortality, perioperative complications, and long-term operative outcome. Results: At 5-year follow-up, mean GIQLI score was significantly higher in the operative group [118.2 (SD 21.0)] than the conservative group [108.5 (SD 20.0)] with a mean difference of 9.7 (95% confidence interval 1.7–17.7). All secondary QoL outcome measures showed significantly better results in the operative group, with a higher SF-36 physical (P = 0.030) and mental score (P = 0.010), higher EQ5D score (P = 0.016), and a lower VAS pain score (P = 0.011). Twenty-six (46%) patients in the conservative group ultimately required surgery due to severe ongoing complaints. Of the operatively treated patients, 8 (11%) patients had anastomotic leakage and reinterventions were required in 11 (15%) patients. Conclusion: Consistent with the short-term results of the DIRECT trial, elective sigmoidectomy resulted in a significantly increased QoL at 5-year follow-up compared with conservative management in patients with recurring diverticulitis and/or ongoing complaints. Surgeons should counsel these patients for elective sigmoidectomy weighing superior QoL, less pain, and lower risk of new recurrences against the complication risk of surgery.

There appears to be no benefit in performing routine colonic evaluation after an episode of diverticulitis as the incidence of colorectal cancer is almost equal to that of the general population. A more selective approach might therefore be justified. Potentially, only patients with persisting abdominal complaints after an episode of diverticulitis should be offered colonic evaluation to definitively exclude causal pathology.

BackgroundPersisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing these two treatment strategies.Methods/designThe DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years.DiscussionConsidering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation.Trial Registration(Trial register number: NTR1478)

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Purpose There is no consensus on the optimal operative technique for humeral shaft fractures. This meta-analysis aims to compare minimal-invasive plate osteosynthesis (MIPO) with nail fixation for humeral shaft fractures regarding healing, complications and functional results. Methods PubMed/Medline/Embase/CENTRAL/CINAHL were searched for randomized clinical trials (RCT) and observational studies comparing MIPO with nailing for humeral shaft fractures. Effect estimates were pooled across studies using random effects models and presented as weighted odds ratio (OR), risk difference (RD), mean difference (MD) and standardized mean difference (SMD) with corresponding 95% confidence interval (95%CI). Analyses were repeated stratified by study design (RCTs and observational studies). Results A total of 2 RCTs (87 patients) and 5 observational studies (595 patients) were included. The effects estimated in observational studies and RCTs were similar in direction and magnitude for all outcomes except operation duration. MIPO has a lower risk for non-union (RD 7%; OR 0.2, 95% CI 0.1-0.5) and re-intervention (RD 13%; OR 0.3, 95% CI 0.1-0.8). Functional shoulder (SMD 1.0, 95% CI 0.2-1.8) and elbow scores (SMD 0.4, 95% CI 0-0.8) were better among patients treated with MIPO. The risk for radial nerve palsy following surgery was equal (RD 2%; OR 0.6, 95% CI 0.3-1.2) and nerve function recovered spontaneously in all patients in both groups. No difference was detected with regard to infection, time to union and operation duration. Conclusion MIPO has a considerable lower risk for non-union and re-intervention, leads to better shoulder function and, to a lesser extent, better elbow function compared to nailing. Although nailing appears to be a viable option, the evidence suggests that MIPO should be the preferred treatment of choice. The learning curve of minimal-invasive plating should, however, be taken into account when interpreting these results.