The application of TachoSil® for sealing colorectal anastomosis: a feasibility study

Parker, Michael; Pohlen, U.; Rinkes, Inne H.M. Borel; Delvin, Thomas

doi:10.1111/j.1463-1318.2012.03144.x

Cited by 26 publications

(25 citation statements)

References 20 publications

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“…1 Another animal study involving TachoSil could identify enhanced fibroblastic activity at the sealed site but failed to identify an inflammatory reaction. 34 Clinical feasibility studies in aortic 22 and bowel 27 anastomosis in 12 patients could not relate an adverse event to the application of TachoSil.…”

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confidence: 99%

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Hütter

Felten²,

Sailer³

et al. 2014

JNS

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W hile performing cranial surgery, it is of utmost importance to achieve a tight and reliable closure of the dura mater. Cerebrospinal fluid leakage leads to increased morbidity, prolongation of hospital stay, surgical revision, and enhanced costs as well as possible surgical revisions. 15,19 The incidence of CSF leakage is reported to depend on the location of surgery (for example, more likely in the posterior fossa)15 but may also depend on the size of the craniotomy and dural opening or on patient-related factors such as immune status, age, or the underlying pathological process. Dural closure is usually achieved with an intended watertight suture and the addition of hemostyptic or hemostatic agents such as fibrin glue or cellulose collections.2,4,12 Several studies have described the use of sealants as useful in avoiding CSF leakage in supratentorial, 4,20,28,33 Object. Cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening. Recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden. The aim of this paper was to investigate whether the addition of TachoSil on top of the dural suture reduces postoperative CSF leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy.Methods. The authors conducted a prospective, randomized, double-blinded single-center trial in patients undergoing elective craniotomy with dural opening. They compared their standard dural closure by running suture alone (with the use of a dural patch if needed) to the same closure with the addition of TachoSil on top of the suture. The primary end point was the incidence of CSF leakage, defined as CSF collection or any open CSF fistula within 30 days. Secondary end points were the incidence of infection, surgical revision, and length of stay in the intensive care unit (ICU) or intermediate care (IMC) unit. The site of craniotomy, a history of diabetes mellitus, a diagnosis of meningioma, the intraoperative need of a suturable dural substitute, and blood parameters were assessed as potential risk factors for CSF leakage.Results. The authors enrolled 241 patients, of whom 229 were included in the analysis. Cerebrospinal fluid leakage, mostly self-limiting subgaleal collections, occurred in 13.5% of patients. Invasive treatment was performed in 8 patients (3.5%) (subgaleal puncture in 6, lumbar drainage in 1, and surgical revision in 1 patient). Diabetes mellitus, a higher preoperative level of C-reactive protein (CRP), and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point (p = 0.014, 0.01, and 0.049, respectively). Cerebrospinal fluid leakage (9.7% vs 17.2%, OR 0.53 [95% CI 0.23-1.15], p = 0.108) and infection (OR 0.18 [95% CI 0.01-1.18], p = 0.077) occurred less frequently in the study group than in the control group. TachoSil significantly reduc...

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mentioning

confidence: 99%

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Hütter

Felten²,

Sailer³

et al. 2014

JNS

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“…Tachosil (Hakeda, Osaka, Japan) has been evaluated in a technically insufficient anastomosis in a mouse model by Pantelis et al 8 This study reported the positive result that Tachosil reduced the anastomotic leakage rate from 36.7% to 5.9%. These results, together with the findings of other studies, 9,10 suggest that Tachosil is one of the most promising agents for colorectal anastomotic coating.…”

mentioning

confidence: 48%

“…One study 9 evaluated the use of Tachosil on small bowel anastomoses in pigs and found that the risk of anastomotic leakage and stenosis was comparable to that of controls. A clinical study 10 evaluated the use of Tachosil on anastomoses in 25 patients treated for rectal cancer with anterior resection and found that the application of Tachosil was technically feasible in 96% of the patients. No complications associated with Tachosil, neither leakage nor stenosis, were recorded.…”

Section: Discussionmentioning

confidence: 99%

Decreased Leakage Rate of Colonic Anastomoses by Tachosil Coating: An Experimental Study

Pommergaard

Achiam

Burcharth

et al. 2014

International Surgery

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Colorectal anastomotic coating has been proposed as a means to lower the leakage rate. Prior to clinical testing, coating materials need thorough experimental evaluation to ensure safety and efficacy. The aim of this study was to evaluate Tachosil as an anastomotic coating agent. Technically insufficient colon anastomoses were created in 80 C57BL/6 mice, and in half of the animals the anastomoses were covered with Tachosil. The animals were examined for clinical signs of anastomotic leakage, and the breaking strength of the anastomoses was evaluated. The number of leakages was reduced by Tachosil coating (10/40 versus 20/40 in controls; P ¼ 0.037). However, more cases of large bowel obstruction were found in the Tachosil group (12/40 versus 0/40 in controls; P , 0.0005). Breaking strength was comparable between the Tachosil and control groups (0.49 N versus 0.52 N, respectively; P ¼ 0.423). Clinical studies are needed to clarify the efficacy of Tachosil anastomotic coating.Key words: Colon anastomotic leakage -Anastomotic dehiscence -Anastomotic failureAnimal model -Experimental -Coating -Tachosil -Sealing A nastomotic leakage remains a feared and frequent complication in gastrointestinal surgery, especially for anastomoses on the colon and rectum, with leakage rates of 3% to 7% and 13%, respectively, 1-5 leading to a mortality rate of up to 27%. 1,6 In addition to existing interventions used to decrease the risk of anastomotic leakage, such as altered surgical techniques, preoperative optimization, and different postoperative regimens, anastomotic coating has been suggested as a potential method.7 Numerous experimental studies evaluating anastomotic coating have reported positive effects; however, contradictory results were found when the same coating material was evaluated by other researchers or in a different study design. Furthermore, a few coating materials have been evaluated in humans, but without convincing 7 In order to establish a rationale for conducting large, clinical, randomized, controlled trials in which specific coating agents are evaluated, positive results have to be reproduced in several animal studies to ensure the safety and efficacy of the materials and methods. Tachosil (Hakeda, Osaka, Japan) has been evaluated in a technically insufficient anastomosis in a mouse model by Pantelis et al. 8 This study reported the positive result that Tachosil reduced the anastomotic leakage rate from 36.7% to 5.9%. These results, together with the findings of other studies, 9,10 suggest that Tachosil is one of the most promising agents for colorectal anastomotic coating.The aim of this study was to evaluate the use of Tachosil to lower the anastomotic leakage rate in a mouse model of the technically insufficient colon anastomosis. Furthermore, we aimed to investigate if the results produced by Pantelis et al 8 were reproducible in our setting. Materials and MethodsEnd-to-end colonic anastomoses were created in 80 male C57BL/6 mice (23-30 g). The animals were anesthetized with isoflurane (isoflurane, 2%...

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“…De Stefano et al [8] showed that its use as a sealant for colorectal anastomosis is associated with a shorter postoperative hospital stay compared with a control group. Recently Parker et al [9] confirmed, in a non-randomized multicentre open-label study, the feasibility and the tolerability of TachoSil in reinforcing colorectal anastomoses. The technique used in the present study is also supported by two recent reports of RUF repair using a porcine small intestinal submucosal graft and a porcine dermal collagen allograft [4,10,11].…”

Section: Discussionmentioning

confidence: 90%

Repair of transperineal recto‐urethral fistula using a fibrin sealant haemostatic patch

et al. 2016

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The application of TachoSil® for sealing colorectal anastomosis: a feasibility study

Abstract: Application of TachoSil to reinforce the anastomotic line in colorectal resections appears to be feasible and well tolerated.

Cited by 26 publications

References 20 publications

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Decreased Leakage Rate of Colonic Anastomoses by Tachosil Coating: An Experimental Study

Repair of transperineal recto‐urethral fistula using a fibrin sealant haemostatic patch

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