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DIRECT trial: Diverticulitis Recurrences or Continuing Symptoms; Operative versus Conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL
Bryan van de WallWerner DraaismaEsther ConstenYolanda van der GraafMarten OttenArdine de WitHenk van StelMichael GerhardsRene WiezerHuib CenseHein StockmannJeroen LeijtensDavid ZimmermanEric BelgersBart van WagensveldEric SonneveldHubert PrinsPeter CoeneTom KarstenJoost KlaaseMarkwin Statius MullerRogier CrollaIvo BroedersDutch Diverticular Disease Collaborative Study Group 3D Study Group Fri, 06 Aug 2010 00:00:00 -0000
Background: Persisting 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)
Ten-year audit of Lichtenstein hernioplasty under local anaesthesia performed by surgical residents
Hannu PaajanenRiitta Varjo Wed, 04 Aug 2010 00:00:00 -0000
Background: To analyse in a prospective trial the long-term results of Lichtenstein hernioplasty performed by surgical trainees. Methods: Training of tension-free Lichtenstein hernia operation was started in our ambulatory unit as an outpatient procedure under local anaesthesia in 1996. After performing 36 teaching operations together with residents and their supervising specialist, 281 patients were operated during 1996-2000 either by one senior consultant (n = 141) or by 12 surgical trainees (n = 140). After 10 years, 247 (88%) patients were available for the long-term assessment. Results: After one month postoperatively, the rate of wound infections (consultant 1.1%, residents 0.7%) and hematomas (consultant 1.1%, residents 3.0%) were low and not related to surgeon's training level (ns). Only 6 (2.1%) clinically evident recurrences were found after 10 years: two after specialist repair and four after trainee repair (ns). Although one third of the patients reported some discomfort after 3 and 10 years, 93-95% of the patients were very satisfied with the operation, with no statistical difference between the surgeons. Conclusion: Ambulatory open mesh repair under local anaesthesia was a safe operation and the long-term results were acceptable among the patients operated by surgical trainees.
A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial).
Cagdas UnluNiels de KorteLidewine DanielsEsther ConstenMiguel CuestaMichael GerhardsAnna van GelovenEdwin van der ZaagJoost van der HoevenRutger KlicksHuib CenseRudi RoumenQuirijn EijsboutsJohan LangePaul FockensCorianne de BorgieWillem BemelmanJohannes ReitsmaHein StockmannBart VrouenraetsMarja Boermeester3D diverticulitis collaboration group . Tue, 20 Jul 2010 00:00:00 -0000
Background: Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods: A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included. Conclusion: A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach.Trial registrationTrial registration number: NCT01111253
Decompressive laparotomy with temporary abdominal closure versus percutaneous puncture with placement of abdominal catheter in patients with abdominal compartment syndrome during acute pancreatitis: background and design of multicenter, randomised, controlled study
Dejan RadenkovicDjordje BajecNenad IvancevicVesna BumbasirevicNatasa MilicVasilije JeremicPavle GregoricAleksandar KaramarkovicBorivoje KaradzicDarko MirkovicDragoljub BilanovicRadoslav ScepanovicVladimir Cijan Mon, 12 Jul 2010 00:00:00 -0000
Background: Development of abdominal compartment syndrome (ACS) in patients with severe acute pancreatitis (SAP) has a strong impact on the course of disease. Number of patients with this complication increases during the years due more aggressive fluid resuscitation, much bigger proportion of patients who is treated conservatively or by minimal invasive approach, and efforts to delay open surgery. There have not been standard recommendations for a surgical or some other interventional treatment of patients who develop ACS during the SAP. The aim of DECOMPRESS study was to compare decompresive laparotomy with temporary abdominal closure and percutaneus puncture with placement of abdominal catheter in these patients. Methods: One hundred patients with ACS will be randomly allocated to two groups: I) decompresive laparotomy with temporary abdominal closure or II) percutaneus puncture with placement of abdominal catheter. Patients will be recruited from five hospitals in Belgrade during two years period. The primary endpoint is the mortality rate within hospitalization. Secondary endpoints are time interval between intervention and resolving of organ failure and multi organ dysfunction syndrome, incidence of infectious complications and duration of hospital and ICU stay. A total sample size of 100 patients was calculated to demonstrate that decompresive laparotomy with temporary abdominal closure can reduce mortality rate from 60% to 40% with 80% power at 5% alfa. Conclusion: DECOMPRESS study is designed to reveal a reduction in mortality and major morbidity by using decompresive laparotomy with temporary abdominal closure in comparison with percutaneus puncture with placement of abdominal catheter in patients with ACS during SAP.Trial registrationClinicalTrials.gov Identifier: NTC00793715
A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene(R) Mesh Elastic versus the partly absorbable Ultrapro(R) Mesh for incisional hernia repair
Christoph SeilerPetra BaumannPeter KienleAndreas KutheJens KuhlgatzRainer EngemannMoritz v. FrankenbergHanns-Peter Knaebel Mon, 12 Jul 2010 00:00:00 -0000
Background: Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene® Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro® Mesh).Methods/DesignIn this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention.DiscussionThis study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients.Trial registrationNCT00646334
A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part(R) Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group
Reinhold LangPetra BaumannKarl-Walter JauchClaudia SchmoorChristine WeisErich OdermattHanns-Peter Knaebel Tue, 06 Jul 2010 00:00:00 -0000
Background: Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed.Methods/DesignThis is a prospective, randomised, controlled, patient blinded and observer blinded, single centr Subscribe to Surgeons_and_Clinics RSS feed