ABSTRACT
BACKGROUND: It remains unclear whether use of self-fixating mesh during laparoscopic inguinal hernia repair (LIHR) impacts postoperative quality of life (QoL). We hypothesize patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving non-fixating mesh. METHODS: An IRB-approved, single-blinded randomized controlled trial was conducted. Patients with primary, unilateral inguinal hernias were randomized to receive either non-fixating (control) or self-fixating mesh. Clinical visits were conducted 3 weeks and 1 year after LIHR. A validated Surgical Outcomes Measurement System (SOMS) instrument was used to assess patients' QoL preoperatively and postoperatively along with Carolinas Comfort Scale (CCS) at 3 weeks and 1 year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests. RESULTS: Two hundred and seventy patients were enrolled (137 non-fixating vs 133 self-fixating). Preoperatively, there was no difference in mean age, BMI, or median hernia duration between groups (57.9 vs 56.6 years, p = 0.550; 26.1 vs 26.8, p = 0.534; 3.0 vs 3.0 months, p = 0.846). Median operative times (34 vs 34 min, p = 0.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p = 0.001). Patients receiving non-fixating mesh recorded better mean SOMS scores for the first 3 days following surgery (Day 1: p = 0.005; Day 2: p = 0.002; Day 3: p = 0.024, Table 1) indicating less pain. No differences in pain were seen 3 weeks or 1 year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups. CONCLUSIONS: Patients receiving self-fixating mesh report worse postoperative pain in the first 2-3 days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3 weeks or 1 year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.
Subject(s)
Hernia, Inguinal/surgery , Herniorrhaphy/instrumentation , Herniorrhaphy/methods , Laparoscopy/instrumentation , Laparoscopy/methods , Surgical Mesh , Adult , Aged , Female , Follow-Up Studies , Herniorrhaphy/adverse effects , Humans , Laparoscopy/adverse effects , Male , Middle Aged , Operative Time , Pain, Postoperative , Patient Outcome Assessment , Prospective Studies , Quality of Life , Single-Blind MethodABSTRACT
BACKGROUND: Peroral endoscopic myotomy (POEM) is a promising therapy in the treatment of achalasia. The study was designed to report outcomes, including quality of life, in patients with at least 1-year follow-up. METHODS: Patients from an institutional review board-approved protocol underwent POEM and were followed prospectively. Health-related quality of life was measured preoperatively and 1 year post-operatively using Short Form-36 Health Survey version 2 (SF-36v2). Comparisons were made with patients from a prospective database who underwent laparoscopic Heller myotomy (LHM) over the same period. Paired t tests were used to analyze all normally distributed data, while Wilcoxon signed-rank tests were used to analyze SF-36 data, as it does not follow a normal distribution. RESULTS: We analyzed 41 consecutive POEM patients with at least 1-year follow-up. Significant improvements in quality of life between baseline and 1 year were found in role limitations due to physical health (81.8 ± 25.8 vs. 65.9 ± 31.6, p = 0.01) and social functioning (83 ± 19.1 vs. 64.6 ± 31.3, p = 0.01). When compared to 24 patients who underwent LHM, there was no difference in average Eckardt scores (0.9 ± 1.6 vs. 1.0 ± 1.3, p > 0.05) or incidence of PPI use (43.5 vs. 47.5 %, p = 0.71). However, when looking at just type III patients, POEM patients had a higher remission rate (100 vs. 62.5 %) and significantly lower post-operative Eckardt scores at 1 year (1.1 vs. 3.1, p < 0.05). The average myotomy length of type III achalasia patients undergoing POEM was 18.6 cm (±6.9) compared to 10.3 cm (±1.0) in LHM patients (p < 0.01), which may have contributed to this difference. CONCLUSION: POEM provides a significant quality of life benefit at 1 year while having similar relief of dysphagia and post-operative PPI use compared to LHM. Type III achalasia patients may have better outcomes with POEM compared to LHM.
