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. 2016 Oct 31;2016(10):CD010683. doi: 10.1002/14651858.CD010683.pub3

Moench 2014.

Methods Randomised clinical trial
Participants Country: Germany
 Number randomised: 128
 Postrandomisation dropouts: 1 (0.8%)
 Revised sample size: 127
 Average age: 61 years
 Women: 53 (41.7%)
 Number of cirrhotics: 0 (0%)
 Number of major liver resections: not stated
 Number of right hepatectomies: not stated
 Follow‐up (months): 3
 Further details of methods of liver resection

  1. Vascular occlusion: not stated

  2. Parenchymal transection: a number of parenchymal transection techniques

  3. Fibrin glue: factor being randomised

  4. Pharmacological methods: none

  5. Cardiopulmonary methods: not stated

  6. Autologous transfusion: not stated


Inclusion criteria:
non‐cirrhotic adult patients undergoing elective open liver resection
Exclusion criteria

  1. Coagulation disorders

  2. Klatskin tumour

  3. Participation in another clinical study within 30 d

  4. Pregnancy or breastfeeding

  5. Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting (including but not limited to tranexamic acid, activated factor VIII, and aprotinin)

  6. Known allergy or hypersensitivity to human thrombin or to human fibrinogen or to riboflavin or to proteins of bovine origin.

  7. Resection area estimated by operating surgeon to be less than 16 cm2

  8. An infected wound area

  9. Persistent major bleeding or no bleeding after primary operative haemostatic procedures
Interventions Participants were randomly assigned to 2 groups.
 Group 1: collagen (n = 62)
 Group 2: fibrin sealant (n = 65)
 Collagen: sangustop fleece (Aesculap AG)
 Fibrin sealant: Tachosil (Nycomed)
Outcomes The outcomes reported were: short‐term mortality, proportion of people with serious adverse events, number of serious adverse events, proportion of people with any adverse events, and number of adverse events.
Notes Authors provided replies in March 2016.
 Reasons for postrandomisation dropouts: the resection area was dry
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Lists with a block size of 4 were generated for each participating center prior to the initiation of the study using the Software RandList of the DatInf GmbH (Tübingen, Germany)".
Allocation concealment (selection bias) Low risk Quote: "A1:1 intraoperative randomization was performed using identical looking, sealed, and numbered opaque envelopes".
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "ESSCALIVER is a single‐blinded trial, i.e., patients were not informed about their assignment in order to increase reliability of secondary outcomes, assessed during the follow‐up visits".
 Comment: healthcare providers were not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Due to the appearance of the products used and the differences in their application, blinding of the primary outcome assessor was not possible".
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: there were postrandomisation dropouts.
Selective reporting (reporting bias) Low risk Comment: the outcomes stated in the protocol wer reported.
Vested interest bias High risk Quote (author reply): "The study was sponsored by Aesculap AG (Tuttlingen , Germany). Clinical Monitoring and data management were contracted to Centrial GmbH (Tübingen, Germany). Statistical planning and analysis was performed by Dr.M.Koehler GmbH (Freiburg, Germany)".
Other bias Low risk Comment: no other bias