The nature and indications for thyroid surgery vary and a perceived risk of haemorrhage post-surgery is one reason why wound drains are frequently inserted. However when a significant bleed occurs, wound drains may become blocked and the drain does not obviate the need for surgery or meticulous haemostasis. The evidence in support of the use of drains post-thyroid surgery is unclear therefore and a systematic review of the best available evidence was undertaken.
To determine the effects of inserting a wound drain during thyroid surgery, on wound complications, respiratory complications and mortality.
We searched the following databases: Cochrane Wounds Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 1, 2007); MEDLINE (2005 to February 2007); EMBASE (2005 to February 2007); CINAHL (2005 to February 2007) using relevant search strategies.
Only randomised controlled trials were eligible for inclusion. Quasi randomised studies were excluded. Studies with participants undergoing any form of thyroid surgery, irrespective of indications, were eligible for inclusion in this review. Studies involving people undergoing parathyroid surgery and lateral neck dissections were excluded. At least 80% follow up (till discharge) was considered essential.
Data collection and analysis
Studies were assessed for eligibility and data were extracted by two authors independently, differences were resolved by discussion. Studies were assessed for validity including criteria on whether they used a robust method of random sequence generation and allocation concealment. Missing and unclear data were resolved by contacting the study authors.
13 eligible studies were identified (1646 participants). 11 studies compared drainage with no drainage and found no significant difference in re-operation rates; incidence of respiratory distress and wound infections. Post-operative wound collections needing aspiration or drainage were significantly reduced by drains (RR 0.51, 95% CI 0.27 to 0.97), but a further analysis of the 4 high quality studies showed no significant difference (RR 1.82, 95% CI 0.51 to 6.46). Hospital stay was significantly prolonged in the drain group (WMD 1.18 days, 95% CI 0.73 to 1.63).
Eleven studies compared suction drain with no drainage and found no significant difference in re-operation rates; incidence of respiratory distress and wound infection rates. The incidence of collections that required aspiration or drainage without formal re-operation was significantly less in the drained group (RR 0.48, 95% CI 0.25 to 0.92). However, further analysis of only high quality studies showed no significant difference (RR 1.78, 95% CI 0.44 to 7.17). Hospital stay was significantly prolonged in the drain group (WMD 1.20 days, 95% CI 0.77 to 1.63).
One study compared open drain with no drain. No participant in either group required re-operation. No data were available regarding the incidence of respiratory distress, wound infection and pain. The incidence of collections needing aspiration or drainage without re-operation was not significantly different between the groups and there was no significant difference in length of hospital stay. One study compared suction drainage with passive closed drainage. None of the participants in the study needed re-operation and data regarding other outcomes were not available. Two studies (180 participants) compared open drainage with suction drainage. One study reported wound infections and minor wound collections, both were not significantly different. The other study reported wound collections requiring intervention and hospital stay; both were not significantly different. None of the participants in either study required re-operation. Data regarding other outcomes were not available.
There is no clear evidence that using drains in patients undergoing thyroid operations significantly improves patient outcomes and drains may be associated with an increased length of hospital stay. The existing evidence is from trials involving patients having goitres without mediastinal extension, normal coagulation indices and the operation not involving any lateral neck dissection for lymphadenectomy.
各類的甲狀腺手術具有個別不同的本質和適應症,而發生手術後出血的風險,則難以完全避免,因此臨床醫師經常會於傷口內留置引流管.然而大出血發生時,傷口引流管可能阻塞,因此引流管之置放,並不意謂著可以完全避免二次手術,同時也不能取代仔細止血 (meticulous haemostasis) 的重要性.證據顯示甲狀腺手術術後,使用引流管的療效不明,因此須要系統性回顧整理現有資料.
◆ 我們使用相關搜尋策略,從以下的資料庫進行查證:Cochrane Wounds Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 1, 2007); MEDLINE (2005 to February 2007); EMBASE (2005 to February 2007); CINAHL (2005 to February 2007).
只有隨機對照試驗符合納入資格.半隨機試驗則予以排除.不論何種適應症，只要受試者接受任何形式的甲狀腺手術,即可列入本次回顧研究。涉及副甲狀腺手術和側頸淋巴腺清除手術的對象都被排除.我們的基本要求是:必須至少有80％受試者，完成術後追蹤 (直到出院) ，才算合格.
◆ 總計有13個符合條件的研究(1646位受試者)。11個研究比較有使用引流管與沒有使用引流管兩組間的差異,這兩組在二次開刀率,呼吸窘迫發生率和傷口感染發生率都沒有顯著差異。使用引流的病人,術後傷口內因血水瀦積,需要針吸 (aspiration) 或引流的風險顯著減少(RR 0.51 ，95％CI0.27 ～ 0.97)，但進一步分析4個高品質的研究,反而沒有發現顯著差異(RR1.82，95 ％ CI0.51至6.46)。使用引流管組別的住院天數顯著延長(WMD1.18天,95％ CI0.73至1.63)。11個研究比較負壓引流和沒有引流，結果2次手術率,呼吸窘迫發生率和傷口感染發生率,都沒有顯著不同.使用引流的病人,術後傷口需要針吸或引流,但不需要正式二次開刀的風險險顯著減少 (RR 0.48, 95% CI 0.25 to 0.92). 然而對高品質試驗做進一步研究分析,沒有發現顯著差異(1.78 ，95 ％ CI0.44至7.17)。使用引流的病人,住院天數顯著延長 (WMD 1.20 days, 95% CI 0.77 to 1.63). 一個研究比較開放式引流和沒有引流。兩組都沒有病人需要二次手術.沒有呼吸窘迫,傷口感染和疼痛發生率的資料.因血水瀦積需要針吸或引流,但不需要正式二次開刀的發生率,在有沒有使用引流的兩組間,沒有顯著差異.住院天數也沒有顯著差異.一個試驗比較負壓式引流和被動非開放式引流,所有受試者都不需要二次開刀.但沒有其他結果的資料.另兩個試驗比較開放式引流和負壓式引流 (180位受試者). 其中一個試驗的傷口感染發生率,與傷口內血水瀦積比率,並沒有顯著不同.另一個試驗,檢視傷口內血水瀦積以致需要治療的比率,以及住院時間長短,亦未見顯著不同.兩試驗中,沒有受試者需要接受二次手術.但有關於其他的治療結果,則付之闕如.
沒有明確的證據判定:對甲狀腺手術後的傷口使用引流，是否顯著改善病況,以及引流和留院天數增加是否有關.現有資料來自甲狀腺腫病人之相關研究,但他 (她) 們的病情均未蔓延到縱隔胸膜,凝血指數檢測正常,而且其手術治療不涉及側頸部淋巴結之切除.
此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。