27
views
0
recommends
+1 Recommend
1 collections
    0
    shares

      To submit your manuscript, please click here

      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial

      research-article

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          Chronic subdural hematoma (cSDH) is one of the most frequent neurosurgical conditions affecting elderly people and is associated with substantial morbidity and mortality. The use of a subdural drain (SDD) after burr-hole trepanation for cSDH was proven to reduce recurrence and mortality at 6 months. To date in neurosurgery practice, evidence-based guidelines on whether an SDD or subperiosteal drain (SPD) should be used do not exist. Currently both methods are being practiced depending on the institute and/or the practicing neurosurgeon.

          Objective

          The aim of this study is to compare the reoperation rates after burr-hole trepanation and insertion of an SPD or SDD in patients with cSDH.

          Methods

          This is a prospective, noninferiority, multicenter, randomized controlled trial designed to include 220 patients over the age of 18 years presenting with a symptomatic cSDH verified on cranial computed tomography or magnetic resonance imaging who are to undergo surgical evacuation with burr-hole trepanation. After informed consent is obtained, patients are randomly allocated to an SPD or SDD group. The primary endpoint is recurrence indicating a reoperation within 12 months.

          Results

          This research is investigator-initiated and has received ethics approval. Patient recruitment started in April 2013, and we expect all study-related activities to be completed by the end of 2016 or beginning of 2017.

          Conclusions

          To date, evidence-based recommendations concerning the operative treatment of cSDH are sparse. Results of this research are expected to have applications in evidence-based practice for the increasing number of patients suffering from cSDH and possibly lead to more efficient treatment of this disease with fewer postoperative complications.

          Trial Registration

          ClinicalTrials.gov NCT01869855; https://clinicaltrials.gov/ct2/show/NCT01869855 (Archived by WebCite at http://www.webcitation.org/6fNK4Jlxk)

          Related collections

          Most cited references10

          • Record: found
          • Abstract: found
          • Article: not found

          Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients.

          To compare the efficacy and safety of multiple treatment modalities for the management of chronic subdural hematoma (CSDH) patients.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Chronic subdural haematoma: surgical treatment and outcome in 1000 cases.

            Chronic subdural haematoma (CSDH) is one of the most common clinical entities in daily neurosurgical practice. To evaluate the clinical features, computed tomography findings, surgical results, and complications our series was statistically analysed to elucidate the factors affecting the post-operative outcome. A retrospective study (1980-2002) of the records of 1000 patients harbouring 1097 chronic subdural haematoma treated with burr-hole craniotomy with closed-system drainage was carried out. The series included 628 males and 372 females, age range 12-100 years, mean age 72.7+/-11.4 years. The mean interval from trauma to appearance of clinical symptoms was 49.1+/-7.4 days (15-751). The principal symptom was headache (29.7%) in the over 70s, and behavioural disturbance (33.8%) in the under 70s. The CSDH was right sided in 432 patients, left sided in 471, and bilateral in the remaining 97 cases. Post-operative complications occurred in 196 patients and 21 patients died in hospital. Poor prognosis was related to patient's age (>70) and clinical grade on admission (grades 0-2 versus grades 3-4).
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              The course of chronic subdural hematomas after burr-hole craniostomy and closed-system drainage.

              A consecutive series of 32 adult patients with chronic subdural hematoma was studied in respect to postoperative cerebral reexpansion (reduction in diameter of the subdural space) after burr-hole craniostomy and closed-system drainage. Patients with high subdural pressure showed the most rapid brain expansion and clinical improvement during the first 2 days. Nevertheless, a computerized tomography (CT) scan performed on the 10th day after surgery demonstrated persisting subdural fluid in 78% of cases. After 40 days, the CT scan was normal in 27 of the 32 patients. There was no mortality and no significant morbidity. Our study suggests that well developed subdural neomembranes are the crucial factors for cerebral reexpansion, a phenomenon that takes at least 10 to 20 days. However, blood vessel dysfunction and impairment of cerebral blood flow may participate in delay of brain reexpansion. It may be argued that additional surgical procedures, such as repeated tapping of the subdural fluid, craniotomy, and membranectomy or even craniectomy, should not be evaluated earlier than 20 days after the initial surgical procedure unless the patient has deteriorated markedly.
                Bookmark

                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications Inc. (Toronto, Canada )
                1929-0748
                Apr-Jun 2016
                08 April 2016
                : 5
                : 2
                : e38
                Affiliations
                [1] 1Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland AarauSwitzerland
                [2] 2Department of Neurosurgery, University Hospital Basel, Basel, Switzerland BaselSwitzerland
                [3] 3Clinical Trial Unit, University Hospital of Basel, Basel, Switzerland BaselSwitzerland
                Author notes
                Corresponding Author: Jehuda Soleman jehuda.soleman@ 123456gmail.com
                Author information
                http://orcid.org/0000-0003-1900-9286
                http://orcid.org/0000-0002-4938-6974
                http://orcid.org/0000-0002-1150-0962
                http://orcid.org/0000-0002-1971-5095
                http://orcid.org/0000-0002-5375-3087
                Article
                v5i2e38
                10.2196/resprot.5339
                4841895
                27059872
                ab7ffb0e-d673-4d10-9821-5a91133c3d38
                ©Jehuda Soleman, Katharina Lutz, Sabine Schaedelin, Luigi Mariani, Javier Fandino. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.04.2016.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 12 November 2015
                : 30 December 2015
                : 3 January 2016
                : 3 January 2016
                Categories
                Protocol
                Protocol

                chronic subdural hematoma,drain,hematoma,recurrent hematoma,burr-hole trepanation

                Comments

                Comment on this article