Bruns Helge, Rahbari Nuh N, Löffler Thorsten, Diener Markus K, Seiler Christoph M, Glanemann Matthias, Butturini Giovanni, Schuhmacher Christoph, Rossion Inga, Büchler Markus W, Junghans Tido
Department of General, Visceral and Transplantation Surgery, Ruprecht-Karls-University Heidelberg, Heidelberg, Germany.
Trials. 2009 Jul 26;10:58. doi: 10.1186/1745-6215-10-58.
Concomitant treatment in addition to intervention may influence the primary outcome, especially in complex interventions such as surgical trials. Evidence-based standards for perioperative care after distal pancreatectomy, however, have been rarely defined. This study's objective was therefore to identify and analyse the current basis of evidence for perioperative management in distal pancreatectomy.
A standardised questionnaire was sent to 23 European centres recruiting patients for a randomized controlled trial (RCT) on open distal pancreatectomy that would compare suture versus stapler closure of the pancreatic remnant (DISPACT trial, ISRCTN 18452029). Perioperative strategies (e.g., bowel preparation, pain management, administration of antibiotics, abdominal incision, drainages, nasogastric tubes, somatostatin, mobilisation and feeding regimens) were assessed. Moreover, a systematic literature search in the Medline database was performed and retrieved meta-analyses and RCTs were reviewed.
All 23 centres returned the questionnaire. Consensus for thoracic epidural catheters (TECs), pain treatment and transverse incisions was found, as well as strong consensus for the placement of intra-abdominal drainages and perioperative single-shot antibiotics. Also, there was consensus that bowel preparation, somatostatin application, postoperative nasogastric tubes and intravenous feeding might not be beneficial. The literature search identified 16 meta-analyses and 19 RCTs demonstrating that bowel preparation, somatostatin therapy and nasogastric tubes can be omitted. Early mobilisation, feeding and TECs seem to be beneficial for patients. The value of drainages remains unclear.
Most perioperative standards within the centres participating in the DISPACT trial are in accordance with current available evidence. The need for drainages requires further investigation.
ISRCTN 18452029.
除干预措施外的伴随治疗可能会影响主要结局，尤其是在诸如外科手术试验等复杂干预中。然而，关于胰体尾切除术后围手术期护理的循证标准鲜有明确界定。因此，本研究的目的是识别并分析胰体尾切除围手术期管理的当前证据基础。
向23个欧洲中心发送了一份标准化问卷，这些中心正在招募患者参与一项关于开放性胰体尾切除术的随机对照试验（RCT），该试验将比较胰腺残端缝合与吻合器闭合（DISPACT试验，ISRCTN 18452029）。评估了围手术期策略（如肠道准备、疼痛管理、抗生素给药、腹部切口、引流、鼻胃管、生长抑素、活动及喂养方案）。此外，在Medline数据库中进行了系统的文献检索，并对检索到的荟萃分析和RCT进行了综述。
所有23个中心均回复了问卷。发现对于胸段硬膜外导管（TEC）、疼痛治疗和横向切口存在共识，对于放置腹腔引流和围手术期单次使用抗生素也有强烈共识。此外，对于肠道准备、生长抑素应用、术后鼻胃管和静脉喂养可能无益也达成了共识。文献检索确定了16项荟萃分析和19项RCT，表明可以省略肠道准备、生长抑素治疗和鼻胃管。早期活动、喂养和TEC似乎对患者有益。引流的价值仍不明确。
参与DISPACT试验的各中心的大多数围手术期标准与当前可得证据一致。引流的必要性需要进一步研究。
ISRCTN 18452029。
