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不同类型网片应用于李金斯坦腹股沟疝修补术疗效的前瞻性研究

Efficacies of different meshes in Lichtenstein repair for inguinal hernia: a prospective study

摘要目的 比较采用聚丙烯聚乳酸复合网片、聚酯网片、聚丙烯网片行李金斯坦腹股沟疝修补术的临床疗效.方法 选取2012年2月至2013年5月天津市人民医院收治的1 080例原发性单侧腹股沟疝患者进行前瞻性研究.采用随机对照研究方法,将入组患者按随机数字表法分为ProGrip组(采用聚丙烯聚乳酸复合网片)、PET组(采用聚酯网片)和PP组(采用聚丙烯网片).患者在局部麻醉下采用标准的李金斯坦无张力疝修补术.采用门诊和电话方式进行随访,随访时间截至2014年5月.随访内容包括并发症发生情况、术后疼痛情况及术后健康相关的生命质量.主要观察指标包括:固定网片时间,手术时间,疝复发情况;术后1周、1个月、6个月、12个月疼痛程度,采用数字评价量表(NRS)评估;术后1个月患者健康相关的生命质量,采用SF-36问卷调查,包括生理机能、生理职能、躯体疼痛、一般健康状况、精力、社会功能、情感职能、精神健康8项.正态分布的计量资料以x-±s表示,多组间比较采用方差分析,两组间比较采用t检验;偏态分布的计量资料以M(范围)表示,重复测量数据采用重复测量方差分析.计数资料比较采用x2检验和Fisher确切概率法.采用Kaplan-Meier法计算术后中、重度疼痛率,Log-rank检验进行分析.结果 筛选出符合条件的患者1 022例,其中ProGrip组患者367例,PET组346例,PP组309例.ProGrip组、PET组、PP组患者固定网片时间分别为(1.3±0.5)min、(4.9±0.9) min、(5.0±0.9) min,手术时间分别为(30 ±5) min、(45 ±7) min、(44±7)min,3组上述两个指标比较,差异均有统计学意义(F=6.21,4.33,P<0.05).固定网片时间和手术时间ProGrip组与PET组比较,差异有统计学意义(t=1.36,4.39,P<0.05);ProGrip组与PP组比较,差异有统计学意义(=2.67,2.99,P<0.05);PET组与PP组比较,差异无统计学意义(t=0.98,0.63,P>0.05).909例患者术后获得随访,随访率为88.943% (909/1 022),随访时间为12 ~ 26个月,中位随访时间为13个月.ProGrip组、PET组、PP组患者术后疝复发分别为1、0、0例,3组比较,差异无统计学意义(P>0.05).ProGrip组、PET组、PP组患者术后1周至12个月疼痛NRS评分分别为0(0 ~2)分~0(0 ~0)分、2(0 ~5)分~0(0~0)分、1(0~4)分~0(0 ~0)分,术后1周至12个月中、重度疼痛患者分别为52例(14.17%) ~0例(0)、87例(25.14%)~0例(0)、89例(28.80%) ~0例(0),3组上述两个指标变化趋势比较,差异均无统计学意义(F=1.66 ,x2=1.52,P>0.05).ProGrip组、PET组、PP组患者术后1个月生理机能分别为(52±4)分、(50±6)分、(50±6)分,生理职能分别为(50±6)分、(50±6)分、(50±5)分,躯体疼痛分别为(52±7)分、(52±7)分、(52±7)分,一般健康状况分别为(63±4)分、(57±9)分、(58±8)分,精力分别为(63±5)分、(62±6)分、(63±6)分,社会功能分别为(58±4)分、(58±8)分、(57±8)分,情感职能分别为(59±4)分、(57±8)分、(58±8)分,精神健康分别为(65±4)分、(63±5)分、(63±6)分,3组上述指标比较,差异均无统计学意义(F=2.36,3.65,1.98,2.41,6.32,2.33,4.21,3.52,P>0.05).结论 采用聚丙烯聚乳酸复合网片、聚酯网片、聚丙烯网片行李金斯坦腹股沟疝修补术后并发症、术后疼痛和生命质量相当,且均在术后远期呈现低复发率、低疼痛发生率和较高的生命质量.

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abstractsObjective To compare the clinical efficacies of polypropylene-polyglactic composite mesh, polyester mesh, polypropylene mesh in Lichtenstein repair for inguinal hernia.Methods The clinical data of 1 080 patients with primary unilateral inguinal hernia who were admitted to the Tianjin People's Hospital from February 2012 to May 2013 were prospectively analyzed.A randomized controlled study was performed based on a random numble table.All the patients were allocated into the ProGrip group (Parietex ProGripTM Self-Fixating Mesh), PET group (ParietexTM Lightweight Monofilament Polyester Mesh) and PP group (BardTM Soft Mesh).Patients received standard Lichtenstein tension-free repair under local anesthesia and were followed up by outpatient examination and telephone interview till May 2014.The indexs observed during the follow-up included occurrence of complications, post-operative pain and postoperative health-related quality of life.The following indexes were recorded : time of mesh fixation, operation time, hernia recurrence, pain degree at postoperative week 1 and month 1, 6, 12 by numerical rating scale (NRS), quality of life at postoperative month 1 by SF-36 questionnaire survey including physical function, role physical, body pain, general health, vitality, social function, role emotional,mental health.Measurement data with normal distribution were presented as x ± s.Comparisons among groups were analyzed by ANOVA and pairwise comparison by t test.Measurement data with skewed distribution were presented as M (range) and repeated measurement data were analyzed using the repeated measures ANOVA.Count data were evaluated by the chi-square test and Fisher exact probability.Postoperative moderate and severe pain rates were evaluated by the Kaplan-Meier method and analyzed by the Log-rank test.Results There were 1 022 patients screened for eligibility including 367 patients in the ProGrip group, 346 patients in the PET group and 309 patients in the PP group.The time of mesh fixation and operation time were (1.3 ± 0.5) minutes and (30 ± 5) minutes in the ProGrip group, (4.9 ± 0.9) minutes and (45 ± 7) minutes in the PET group, (5.0 ± 0.9) minutes and (44 ± 7)minutes in the PP group, respectively, showing significant differences among the 3 groups (F =6.21, 4.33,P < 0.05).There were significant differences in the time of mesh fixation and operation time between the ProGrip group and the PET group (t =1.36, 4.39, P < 0.05), and also between the ProGrip group and the PP group (t =2.67, 2.99, P < 0.05).There was no significant difference in the time of mesh fixation and operation time between the PET group and the PP group (t =0.98, 0.63, P > 0.05).Nine hundred and nine patients were followed up for a median time of 13 months (range, 12-26 months) , with a follow-up rate of 88.943% (909/1 022).The number of recurred hernia in the ProGrip group, the PET group and the PP group was 1, 0, 0,showing no significant difference (P > 0.05).The NRS scores of pain from postoperative week 1 to postoperative month 12 were ranged from 0 (0-2) to 0 (0-0) in the ProGrip group, from 2(0-5) to 0(0-0) in the PET group and from 1 (0-4) to 0 (0-0) in the PP group.The number of patients with moderate and severe pain was ranged from 52(14.17%) to 0(0) in the ProGrip group, from 87 (25.14%) to 0 (0) in the PET group and from 89 (28.80%) to 0(0) in the PP group.There were no significant differences in the changing trends of NRS scores of pain and number of patients with moderate and severe pain among the 3 groups (F =1.66, x2=1.52, P > 0.05).The scores of physical function in the ProGrip group, PET group, PP group at postoperative month 1 were 52 ± 4,50 ± 6, 50 ± 6, the scores of role physical were 50 ± 6, 50 ± 6, 50 ± 5, the scores of body pain were 52 ± 7, 52 ± 7, 52 ± 7, the scores of general health were 63 ± 4, 57 ± 9, 58 ± 8, the scores of vitality were 63 ± 5, 62 ± 6,63 ± 6, the scores of social function were 58 ± 4, 58 ± 8, 57 ± 8, the scores of role emotional were 59 ± 4, 57 ± 8,58 ± 8, and the scores of mental health were 65 ± 4, 63 ± 5, 63 ± 6, respectively, showing no significant differences in above indexes among the 3 groups (F =2.36,3.65,1.98,2.41, 6.32, 2.33, 4.21, 3.52, P > 0.05).Conclusion Patients undergoing Lichtenstein repair for inguinal hernia with polypropylene-polyglactic composite mesh, polyester mesh and polypropylene mesh have comparative of incidence of postoperative complications, postoperative pain, quality of life, and present postoperative long-term low recurrence, low incidence of pain and relatively high quality of life.

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