Skip to main content
. 2021 May 28;2021(5):CD011563. doi: 10.1002/14651858.CD011563.pub2

Langenbach 2020.

Study characteristics
Methods Randomised controlled trial
Location
Department of Surgery, Helios St. Elisabeth Klinik Oberhausen, Germany
Study dates 
Between January 2016 until January 2018
Participants Inclusion criteria
Abdominal wall hernia needing open surgery, written informed consent, no co‐existing chronic diseases with permanent use of analgesics, no neuro‐muscular diseases with chronic pain sensation, no emergency operations or other simultaneous interventions, no pregnancy or patients with previous IPOM procedure
Patient characteristics (absorbable tacks (28) / absorbable sutures (20))
Age (mean, SD): 62.2 (15.3), 61.4 (12.8)
Gender (male, %): 11 (39%) / 8 (40%)
BMI (kg/m2, mean, range): 34.0 (6.6) / 31.2 (6.3)
Hernia type (incisional, %): 20 (71%) / 17 (85%)
Hernia size (median, range): 33 (4 – 204) / 46 (4 – 616)
Comorbidity:
  • Hypertension: 18 (64%) / 11 (55%)

  • Diabetes: 9 (32%) / 7 (35%)

  • COPD: 4 (14%) / 2 (10%)

  • Coronary Heart Disease: 5 (18%) / 4 (20%)

Interventions Intervention/control: absorbable tacks (2 cm distance) compared to absorbable sutures (2 cm distance)
Mesh: composite mesh
Intra‐abdominal mesh position: IPOM
Surgical approach: open
Outcomes Recurrence (1 year), pain (primary outcome), HRQOL, return to activity, postoperative complications, duration of surgery
Notes Funding source(as originally reported) Not reported. 
Declarations of interest for the primary investigators (as originally reported) There is no conflict of interests
Data for sensitivity analyses
Randomised: 28/20
Analysed: not reported
Imputed in ITT sensitivity analysis: not applicable
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random list
Allocation concealment (selection bias) Low risk Group allocations were stored in sequentially‐numbered opaque, sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes High risk Surgeon not blinded. Other caregivers and participants unclear
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported. Tendentially recurrence "lower risk" (objective outcome), pain "higher risk" (subjective outcome)
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropouts
Selective reporting (reporting bias) Low risk The study protocol is not available but it seems that the published reports include all expected outcomes, including those that were prespecified
Other bias Low risk None detected