Standardization of laparoscopic intraperitoneal onlay mesh repair for incisional hernia: Impact on clinical outcome and quality-of-life (LIPOM trial, NCT 02089958).

Purpose: Current available outcome data following laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia (IH) are comparable to a limited extent only because of a huge number of variability particulary in surgical technique and use of medical devices. In this prospective observational multicenter cohort study we evaluate the impact of a consensus driven standard protocol for IPOM, that is mesh fixation with absorbable tacks in double crown technique enforced by additional non-absorbable transfascial sutures at the edges of the mesh along with the use of Physiomesh™, on clinical and patient reported outcome measures. Methods: A total of 102 consecutive patients were screened for eligibility between September 2013 and October 2014. 85 patients (IH: EHS W1: n = 39, W2: n = 46) were included into the study. Clinical examination and PROM for pain and quality of life measure (Carolina Comfort Scale, CCS) were performed at baseline, during hospital stay and at 6 weeks, 6 months and 1 year follow-up. Results: The follow-up rate was 87,1 % for the primary endpoint. The Kaplan-Meier estimate for freedom-of-recurrence at 1 year was 95.9 % (95 %-CI: 87.9-98.7 %), the cumulative recurrence rate at 1 year was 4.1 % (95 %-CI: 0.9-11.7 %). There was no intraoperative complication. One seroma (type I; 1/84 (1,2 %), 95 %-CI: 0-7.1 %) was diagnosed during hospital stay. 12 seroma (n = 12/74 (16,2 %), 95 %-CI: 9.4-26.4 %; n = 10 type II and n = 2 type IV) were diagnosed during follow-up requiring surgical intervention in 1 patient (1,4 %, Clavien Dindo grade IIIb). Subcutaneous hematoma were found during follow-up in 8 patients (8/75 (10.7 %); 95 %-CI: 5.3-19.9) with need for surgical intervention in 2 patients (2,7 %, Clavien Dindo grade IIIb). There were 3 superficial surgical site infections (3/74 (4,1 %); 95 %-CI: 0.9-11.7 %, Clavien-Dindo grade I) without need for reoperation. Patient reported pain as measured by numeric rating scale at baseline was 1.36 ± 1.53 and 0.35 ± 1.04 at 1 year follow-up. CCS total scores indicated a good outcome with a decrease to 2.80 ± 6.47 (Min: 0, Q1: 0, Median: 0; Q3: 3.0; Max: 38.0) at 1 year follow-up. Subscore sensation of mesh decreased from 4.01 ± 6.76 (min: 0, Q1: 0, Median: 0; Q3: 5.0; Max: 28.0) at 6 weeks to 1.67 ± 3.99 (Min: 0, Q1: 0, Median: 0; Q3: 1.0; Max: 21.0) after 6 months and 0.90 ± 2.69 (Min: 0, Q1: 0, Median: 0; Q3: 0; Max: 14.0) after 1 year follow-up. Subscores pain and movement limitation both decreased during follow-up and were significantly reduced at 1 year compared to preoperative assessment (p < 0.001). Conclusions: This study showed favourable clinical and patient reported outcomes and a low rate of recurrences at 1 year follow-up after IPOM for elective IH applying a standardized surgical technique including the use of Physiomesh™. In view of the data leading to the market withdrawal of the Physiomesh™, one might conclude, that the described standard may have contributed to a compensation of the suspected delay in tissue integration of the Physiomesh™ resulting in a more proper mesh fixation compared to absorbable tack fixation with/without absorbable TFS. This may lead to the general appraisal, that the fixation technique has to be adapted to the individual characteristics of type of mesh and fixation devices and the planned anatomic landing zone of the mesh.