Intervention Review

Intra-peritoneal prophylactic agents for preventing adhesions and adhesive intestinal obstruction after non-gynaecological abdominal surgery

  1. Senthil Kumar1,*,
  2. Peng F Wong2,
  3. David J Leaper3

Editorial Group: Cochrane Colorectal Cancer Group

Published Online: 21 JAN 2009

Assessed as up-to-date: 2 AUG 2008

DOI: 10.1002/14651858.CD005080.pub2


How to Cite

Kumar S, Wong PF, Leaper DJ. Intra-peritoneal prophylactic agents for preventing adhesions and adhesive intestinal obstruction after non-gynaecological abdominal surgery. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD005080. DOI: 10.1002/14651858.CD005080.pub2.

Author Information

  1. 1

    Queens Hospital, Directorate of Surgery, Romford, Essex, UK

  2. 2

    University Hospital of North Tees, Department of Surgery, Hardwick, Stockton on Tees, UK

  3. 3

    Cardiff University, Department of Wound Healing, Cardiff, Wales, UK

*Senthil Kumar, Directorate of Surgery, Queens Hospital, Rom Valley way, Romford, Essex, RM7 0AG, UK. sanskrity@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 21 JAN 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Intra-abdominal adhesions are common and challenge patients, surgeons and other healthcare providers. They are potentially preventable and several agents that act as barriers between adjacent peritoneal surfaces have been evaluated for prophylaxis. Efficacy, judged by systematic reviews, has only been undertaken in gynaecological surgery.

Objectives

To determine efficacy and safety of peritoneal adhesion prophylaxis on incidence, distribution and adhesion-related intestinal obstruction after non-gynaecological surgery.

Search methods

The Cochrane Central Register of Controlled Trials, the Cochrane Colorectal Cancer Group specialised register, MEDLINE (1966-2008), and EMBASE (1971-2008) were searched.

Selection criteria

Blinded and non-blinded, randomised and quasi-randomised clinical trials were considered.

Data collection and analysis

Two authors individually conducted the searches and assessed the quality of studies for inclusion which were analysed using the Revman Analyses software 5.0.0 provided by the Cochrane collaboration. Meta-analysis used a random effects model.

Main results

Seven randomised trials were eligible; six compared hyaluronic acid/carboxymethyl membrane (HA/CMC) and one 0.5% ferric hyaluronate gel against controls.

HA/CMC reduced the incidence of adhesions (OR 0.15 (95% CI: 0.05, 0.43); p=0.0005) with reduced extent (WMD -25.9% (95% CI: -40.56, -11.26); p=0.0005) and severity. There was no reduction of intestinal obstruction needing surgical intervention (odds ratio: 0.84 (95% CI: 0.24, 2.7) with comparable overall morbidity and mortality.

The study of 0.5% ferric hyaluronate gel was prematurely terminated and no valid conclusions could be made but there was a higher incidence of overall morbidity (OR 5.04; 95% CI: 1.1, 22.9) and ileus (OR: 9.29; 95% CI: 1.57, 54.77; p=0.01).

Authors' conclusions

Implications for practice

There is evidence that the use of HA/CMC membrane reduces incidence, extent and severity of adhesions which may, theoretically, have implications in re-operative abdominal surgery. There is no evidence that the incidence of intestinal obstruction or need for operative intervention is reduced. HA/CMC appears to be safe but there may be a risk of leak when wrapped around an anastomoses. HA/CMC may be considered for intra-abdominal, adhesion prophylaxis at a surgeon’s discretion and clinical context.

Implications for research

Further research is needed to explore the effectiveness of other agents in abdominal surgery in general. Synergism, using agents which target different aspects of adhesiogenesis, with exploration effectiveness in a wide range of emergency and elective surgery should be considered. Longer term outcomes of recurrent intestinal obstruction and chronic pain, identification of high risk groups of patients with evaluation of cost-effectiveness are required.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

The use of hyaluronic acid/carboxymethyl cellulose (HA/CMC) membrane, reduces the incidence, extent and severity of adhesions in the abdomen.

Adhesions in the abdomen cause abnormal bonding between adjacent peritoneal surfaces and are common after operations in the abdomen. They are composed of fibrous tissue but also contain blood vessels, fat and nerves. They result in a spectrum of problems that affect the patient (intestinal blockage, infertility and possibly pain); the surgeon (difficulties in access and dissection, prolongation of operative time, increase in blood loss, predisposition to bowel injury); the health care provider (increased cost due to readmissions and litigation). Prevention is the key. This review focus on the evaluation of the safety and efficacy of two preventive agents applied in the abdomen during general surgical operations, Hyaluronic acid /carboxymethyl cellulose membrane and 0.5% ferric hyaluronate gel.
There is evidence to suggest that use of Hyaluronic acid/carboxymethyl cellulose membrane reduces the incidence, severity and extent of adhesions.However, it does not reduce the incidence of subsequent intestinal obstruction or need for surgery to treat the obstruction, when it occurs. It appears to be safe with no significant increase in adverse effects or deaths when compared to control. There is limited data on 0.5% ferric hyaluronate gel with only one study available. This study did not report on the efficacy of the gel as it was prematurely terminated because of a significantly higher rate of adverse effects in the patients who were treated with this gel.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

使用腹膜內預防性藥物來預防非婦科腹部手術後的沾黏(adhesions)和沾黏性腸阻塞(adhesive intestinal obstruction)

腹腔內沾黏現象非常普遍,也是考驗患者、醫師和其他護理人員的一項挑戰,腹腔內沾黏是有可能可以預防的,並且有多種藥物可以用來當作相鄰腹腔表面的屏障藥劑,經過評估這些藥劑可以用來進行預防性治療,目前只有婦產科正在針對這樣的功效進行系統性的整理及判斷

目標

本研究的主要目的在於瞭解進行婦產科以外的腹部手術後,進行腹膜沾黏預防治療對於預防沾黏的發生、治療沾黏和因為沾黏引發的腸阻塞的有效性及安全性

搜尋策略

本研究檢索了Cochrane Central Register of Controlled Trials、Cochrane Colorectal Cancer Group specialised register、MEDLINE (1966−2008)和EMBASE (1971−2008)等資料庫

選擇標準

盲性、非盲性、隨機性、類隨機性臨床試驗都會被考量是否納入研究中

資料收集與分析

有2位作者分別進行檢索,並且評估試驗品質以決定是否納入研究中,納入研究的試驗會使用由Cochrane 研究院提供的RevMan分析軟體5.0.0版本進行分析,進行後設分析時係採用隨機效應模式

主要結論

有7個隨機性試驗適合納入本研究中,其中有6個係比較醣醛酸/羧甲基薄膜(hyaluronic acid/carboxymethyl membrane,HA/CMC)和0.5%醣醛酸鐵膠體(ferric hyaluronate gel)與對照組的差異,使用HA/CMC的組別可以降低沾黏的發生(OR值為.15,95%的信心區間介於0.05至0.43之間,p = 0.0005)、減少發生沾黏的範圍(WMD值為 −25.9%,95%的信心區間介於 −40.56至 −11.26之間,p = 0.0005),並且降低沾黏的嚴重程度,與可比較的整體罹病率和死亡率來說,並沒有發生腸道阻塞並且需要進行手術治療的現象(OR值為0.84,95%的信心區間介於0.24至2.7之間),關於使用0.5%醣醛酸鐵膠體的研究則是過早結束實驗,因此沒有得到有效的結論,但是試驗中卻出現了較高的整體罹病率(OR值為5.04,95%的信心區間介於1.1至22.9之間)和腸阻塞現象(OR值為9.29,95%的信心區間介於1.57至54.77之間,p = 0.01)

作者結論

實務上的意義: 有證據顯示使用HA/CMA薄膜可以降低沾黏的發生率、減少沾黏的範圍以及降低沾黏的嚴重程度,所以理論上有可能在重新進行腹部手術中可能產生併發症,但是並沒有證據說明有發生腸阻塞現象,需要進行手術的機率也降低了,HA/CMA對於患者來說顯然是具有安全性的,但是當其使用在吻合術切口周圍時,卻有可能發生滲漏的風險,因此就外科醫師的判斷以及臨床的角度來說,使用HA/CMA薄膜也許可以被當作一種用來預防腹腔內沾黏的方法,但是仍然需要更多的試驗來探討常用於腹部手術的其他藥劑的有效性。藥物的協同作用(Syn

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌

總結

使用醣醛酸/羧甲基纖維素(HA/CMC)薄膜來降低腹部沾黏的發生率、縮小沾黏的範圍以及降低沾黏的嚴重程度:發生在腹部的沾黏會使得腹部的相鄰腹腔表面發生相黏的現象,也是進行腹部手術後的常見症狀,沾黏是由纖維組織、甚至血管、脂肪和神經所組成,並引發許多問題而對病患(例如腸阻塞(intestinal blockage)、不孕(infertility)和可能引發疼痛)、醫師(不易正確的到達手術部位、延長手術時間、增加患者失血和可能造成腸道受傷)和醫療照護者(因為需要再住院治療及調整治療方式而增加成本)造成困擾,因此預防沾黏的發生便是一個關鍵性的重點,本研究便致力於評估在進行一般手術時使用於腹部的兩種預防性藥劑的安全性及有效性,這兩種藥劑分別為HA/CMC薄膜和0.5%糖醛酸鐵膠體,目前的證據顯示使用HA/CMC可以降低沾黏的發生率、嚴重程度和沾黏的範圍,但是並沒有辦法降低隨後可能發生的腸阻塞或是發生腸阻塞時需要藉由手術治療阻塞現象,相對於對照組來說,使用HACMC顯然是一種具有安全性的方法,而且不會明顯的提高不良事件或死亡事件的發生率,目前只有一個可用的試驗是研究05%醣醛酸鐵膠體的功效,但是其中提出的數據十分有限,本研究並無法對使用這個膠體的安全性提出報告,因為這個試驗中使用膠體的患者因為不良事件發生率明顯的增加而使得試驗必須提早終止