Pain and convalescence following laparoscopic ventral hernia repair.

Severe pain is usual after laparoscopic ventral hernia repair (LVHR). Mesh fixation with titanium tacks may play a key role in the development of acute and chronic pain and alternative fixation methods should therefore be investigated. This PhD thesis was based on three studies and aimed too: 1) assess the intensity and impact of postoperative pain by detailed patient-reported description of pain and convalescence after LVHR (Study I), 2) evaluate the feasibility of fibrin sealant (FS) for mesh fixation in an experimental pig model (Study II), and 3) investigate FS vs. tacks for mesh fixation in LVHR in a randomised, double-blinded, clinical controlled study with acute postoperative pain as the primary outcome (Study III). In Study I - a prospective descriptive study - 35 patients were prospectively included and underwent LVHR. Scores of pain, quality of life, convalescence, fatigue, and general well-being were obtained from each patient. Follow-up was six months. Average pain from postoperative day (POD) 0-2 and POD 0-6 measured on a 0-100 mm visual analogue scale (VAS) was 61 and 48, respectively. Pain scores reached preoperative values at POD 30. The incidence of severe chronic pain was 7%. No parameter predicted postoperative pain significantly. Significant correlations were found between pain, and general well-being (rS= -0.8, p < 0.001), satisfaction (rS= -0.67, p < quality of life score (rS= -0.63, p < 0.001) six months postoperatively. Patients resumed normal daily activity at POD 14. In Study II - a randomised experimental study in pigs - nine pigs were operated laparoscopically with insertion of two different meshes fixed with either FS or tacks. All pigs were euthanized on POD 30. The primary outcome parameter was strength of ingrowth between the mesh and the anterior abdominal wall. A mechanical peel test was performed for each tissue sample. The secondary outcome parameters were grade and strength of adhesions to the mesh, shrinkage and displacement/folding of the mesh and histological parameters. All nine pigs survived without complications until sacrifice. No meshes were displaced from their initial position at autopsy, but in two cases mesh folding was observed. No significant difference in strength of ingrowth was found between different fixation methods or mesh types. Furthermore, no significant difference was found in grade or strength of adhesions or any histological parameters. In Study III - a randomised, controlled, double-blinded, multicenter trial - 40 patients with umbilical hernia defects between 1.5-5 cm, were randomly assigned to receive FS or titanium tacks for mesh fixation in LVHR. Patients, care givers and those assessing the outcomes were blinded to group assignment. The primary outcome was average pain from POD 0-2 (VAS score). Secondary outcome parameters were fatigue, general well-being and time to resume normal daily activity. Follow-up was one month for all. Patients in the FS group reported significantly less pain at POD 0-2 (median VAS 38 (range 6-98) vs. 60 (18-96), p = 0.01). Absolute VAS score difference between groups was 20 mm (95% CI 4-35 mm) at activity, and 19 mm (95% CI 3-34 mm) at rest. Patients in the FS group reported significantly less discomfort from POD 0-2 and POD 0-10, compared with the tack group. No significant difference was found in fatigue score between groups. No significant difference in hospital stay, hernia diameter, or morphine consumption in the post anesthesia care unit was found between groups. Patients in the FS group resumed normal daily activity at POD 7 (1-66) versus POD 18 (1-95) in the tack group (p = 0.03). No recurrences were observed. No adverse events or side effects were observed. No significant differences in predefined complications were found between groups. In conclusion, pain is a significant clinical problem after LVHR with impact on general well-being, quality of life and patient satisfaction. This issue must have first priority in future ventral hernia repair research. It is now documented, that the simple application of fibrin glue instead of titanium tacks for mesh fixation in LVHR of defects < 5 cm significantly reduced acute pain, discomfort and the period of convalescence. Long-term follow-up will show the value of FS fixation in terms of chronic pain and recurrence. As FS potentially may solve many of the outcome problems associated with LVHR, future studies should include larger hernia defects including large incisional hernias, as the operative technique may be different.

RCT Entities:   Population Interventions Outcomes