PDF(Pubmed)
Abstract：
BACKGROUND: The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5-8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall-specific quality of life score.
METHODS: Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients\' original allocation, even if the patient was aware of their treatment.
RESULTS: Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (-2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04).
CONCLUSIONS: ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall-specific quality of life 5-8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on.
BACKGROUND: ISRCTN25584182 (http://www.clinicaltrials.gov).
METHODS: Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients\' original allocation, even if the patient was aware of their treatment.
RESULTS: Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (-2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04).
CONCLUSIONS: ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall-specific quality of life 5-8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on.
BACKGROUND: ISRCTN25584182 (http://www.clinicaltrials.gov).
摘要：
背景：最初的ROCSS试验表明，在造口闭合期间接受预防性生物网片的患者中，2年时临床可检测的切口疝显著减少。ROCSS-Ex旨在使用腹壁特定的生活质量评分来调查存活队列中网状物的5-8年成本效益。
方法：确定了来自原始英国中心的合格参与者。使用HerQLes评分和EQ-5D-5L测量主要结果(腹壁特异性生活质量)。评估人员对患者的原始分配仍然视而不见，即使病人知道他们的治疗。
结果：在最初的790名患者中，598人可用于长期随访。HerQLes评分可用于396例患者(无网格:191,网格:205)。两组之间的主要结局没有差异（平均差异为1.48，95％c.i.（-2.35，5.32），P=0.45），并且从长期来看，在整个队列中常规插入预防性生物网状物没有成本效益。然而,接受网片的患者在逆转后的前3年内经历了明显更少的造口部位并发症，需要更少的手术再干预(无网片组32对54;发生率为0.55,95%c.i.(0.31,0.97),P=0.04)。
结论：ROCSS-Ex对预防性网片插入与标准修复术后5-8年腹壁特异性生活质量的影响显示出模棱两可的结果。由于大多数再干预发生在手术后的前3年内，在早期反复手术对患者影响最大的亚组中,预防性网片可能具有一定的作用.
背景：ISRCTN25584182(http://www.clinicaltrials.gov）。
方法：确定了来自原始英国中心的合格参与者。使用HerQLes评分和EQ-5D-5L测量主要结果(腹壁特异性生活质量)。评估人员对患者的原始分配仍然视而不见，即使病人知道他们的治疗。
结果：在最初的790名患者中，598人可用于长期随访。HerQLes评分可用于396例患者(无网格:191,网格:205)。两组之间的主要结局没有差异（平均差异为1.48，95％c.i.（-2.35，5.32），P=0.45），并且从长期来看，在整个队列中常规插入预防性生物网状物没有成本效益。然而,接受网片的患者在逆转后的前3年内经历了明显更少的造口部位并发症，需要更少的手术再干预(无网片组32对54;发生率为0.55,95%c.i.(0.31,0.97),P=0.04)。
结论：ROCSS-Ex对预防性网片插入与标准修复术后5-8年腹壁特异性生活质量的影响显示出模棱两可的结果。由于大多数再干预发生在手术后的前3年内，在早期反复手术对患者影响最大的亚组中,预防性网片可能具有一定的作用.
背景：ISRCTN25584182(http://www.clinicaltrials.gov）。
