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. 2017 Feb 7;2017(2):CD010814. doi: 10.1002/14651858.CD010814.pub2

Paajanen 2011.

Methods Randomized multi‐centre trial conducted in the ambulatory surgery unit of 3 hospitals in Finland.
Unilateral hernia.
Country: Finland.
Setting: 3 hospitals in Finland (100 in hospital A, 80 in hospital B and 122 in hospital C).
Enrolment dates: between June 2007 and May 2009.
Participants Inclusion criteria:

  • The study subjects were all over 18 years old with unilateral or bilateral inguinal hernia. People who fulfilled the criteria for day‐case surgery received written and oral information about the aims and conduct of the study. Every included participant gave informed consent.


Exclusion criteria:

  • Known femoral hernia, large scrotal hernia, emergency operation for strangulated hernia, recurrent hernia, allergy to polypropylene and participant refusal.


Glue group:

  • 151 participants

  • Age (years), Mean (SD): 53 (15)

  • Sex ratio (M:F): 131:20

  • Body mass index (kg/m2), Mean (SD): 25(3)

  • Side of hernia: left, 39.1%; right, 60.9%

  • Hernia type: direct, 27.2%; indirect, 68.8%; combined, 4.0%

  • Size of defect (cm): < 1.5, 36.4%; 1.5 to 3.0, 54.3%; > 3.0, 9.3%

  • Preoperative use of analgesia: 25.8%

  • Preoperative pain score (VAS), Mean (SD): 4.0 (2.4)

  • Duration of symptoms (months), mean (SD): 18 (28)


Suture group:

  • 151 participants

  • Age (years), Mean (SD): 53 (15)

  • Sex ratio (M:F): 135:16

  • Body mass index (kg/m2), mean (SD): 25(3)

  • Side of hernia: left, 52.3%; right, 47.7%

  • Hernia type: direct, 36.4%; indirect, 59.6%; combined, 4.0%

  • Size of defect (cm): < 1.5, 33.1%; 1.5–3.0, 60.3%; > 3.0, 6.6%

  • Preoperative use of analgesia: 23·2%

  • Preoperative pain score (VAS), mean (SD): 4.0(2.5)

  • Duration of symptoms (months), mean (SD): 28 (58)
Interventions Lichtenstein inguinal hernioplasty with 9 × 13 cm trimmed lightweight polypropylene mesh (Optilene® 60 gr/m²; B. Braun, Melsungen, Germany).
Glue group:

  • Butyl‐2‐cyanoacrylate tissue glue (Glubran®; GEM, Viareggio, Italy).


Suture group:

  • Absorbable polyglycolic acid 3/0 sutures (Dexon®).
Outcomes Recurrences, chronic pain, postoperative complications (e.g. haematoma, infection), length of operation, time to discharge, recovery time to normal activity
Notes Handling of nerves:

  • The ilioinguinal, genitofemoral and iliohypogastric nerves were identified and preserved, if possible. Care was taken not to include the nerves within the sutures.


Length of follow‐up: 1 year.
Time points of the analysis: 3 months for chronic pain and 1 year for recurrence.
Intention‐to‐treat analysis:no.
The number of participants randomized: 151 in Glue group; 151 in Suture group
The number of participants evaluated: 144 in Glue group; 142 in Suture group
In people with bilateral hernia, each one was treated individually; the second operation began when the first had finished in order to time each operation precisely.
NCT00659542 (http://www.clinicaltrials.gov).
The costs of research nurses and other technical assistants were covered by the hospitals’ research funds. No financial or material support was received from any commercial company. The authors declare no conflict of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Randomization was done separately in each participating center.”; “Treatment allocation was by means of sealed, numbered envelopes opened in sequence.”
Comment: probably done, since report from the same investigators in the same period was published on JAMA (APPAC trial, NCT01022567), and this study has also been registered. The registration number is NCT00659542 (http://www.clinicaltrials.gov).
Allocation concealment (selection bias) Low risk Treatment allocation was by means of sealed, numbered envelopes opened in sequence.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The staff who conducted the postoperative assessment and the participants themselves were blinded to the treatment allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The staff who conducted the postoperative assessment and the participants themselves were blinded to the treatment allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The proportion of missing outcomes was comparable between 2 groups (144/151 in the cyanoacrylate glue group and 142/151 in the suture group completed 1‐year follow‐up).
Selective reporting (reporting bias) Low risk It is clear that the published reports include all expected outcomes.
Other bias Low risk The source of funding was a hospitals' research funds. No financial or material support was received from any commercial company. The source of funding was a medical foundation and we consider this trial to be free from risk of 'source of funding' bias.