Randomized clinical trial comparing lightweight mesh with heavyweight mesh for primary inguinal hernia repair

Purpose

The aim of the present randomized clinical trial was to compare feeling of a foreign body and the early and late outcomes after inguinal hernia repair with the heavyweight (HW) mesh and lightweight (LW) mesh during a 12-month follow-up at a single specialist center.

Materials and methods

One hundred and ten patients were randomized into HW and LW mesh groups, both of which underwent unilateral primary inguinal hernia via the Lichtenstein technique. At each postoperative visit, any complication, recurrence, feeling of a foreign body, quality of life, residual pain, and numbness were recorded.

Results

Complaint of feeling of a foreign body on the repaired side was more frequent in the HW mesh group than in the LW mesh group (P < 0.05). Fewer patients in the LW mesh group reported postoperative numbness around the groin or down the thigh than did those in the HW mesh group (P < 0.05). At 12-month follow-up, however, there was no difference between the LW and HW mesh groups as regards the incidence or severity of pain or discomfort and recurrence rate and nor was there any significant dissimilarity between the two study groups in any dimension of quality of life on the SF-36.

Conclusion

There was no significant difference between our LW mesh and HW mesh groups in terms of chronic pain incidence, recurrence rate, and quality of life following inguinal hernia repair. However, fewer patients in the LW mesh group reported numbness around the groin or down the thigh postsurgery than did those in the HW mesh group and therein may lie in the superiority of LW mesh for inguinal hernia repair. Larger cohort studies with longer follow-up periods are required to elucidate in the future the benefits of the LW mesh.     

Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia

BACKGROUND: This randomized trial examined whether lightweight (LW) polypropylene mesh (large pore size, partially absorbable) could have long-term benefits in reducing chronic pain and inflammation after inguinal hernia repair. METHODS: Six hundred men with a primary unilateral inguinal hernia were randomized to Lichtenstein repair using a standard polypropylene mesh or a LW mesh in one of six centres. The patients were blinded to which mesh they received. Clinical examination was performed and a pain questionnaire completed 3 years after surgery. RESULTS: Of the 590 men who had surgery, 243 (82.7 percent) of 294 in the standard mesh group and 251 (84.8 percent) of 296 in the LW mesh group were examined in the clinic, a median of 37 (range 30-48) months after hernia repair. There were nine recurrent hernias in each group (3.7 percent with standard mesh and 3.6 per cent with LW mesh). Patients who had LW mesh had less pain on examination, less pain on rising from lying to sitting, fewer miscellaneous groin problems and felt the mesh less often than patients with standard mesh. CONCLUSION: Use of LW mesh for Lichtenstein hernia repair did not affect recurrence rates, but improved some aspects of pain and discomfort 3 years after surgery.     

Three-year results of randomised clinical trial comparing lightweight mesh with heavyweight mesh for inguinal hernioplasty

Purpose

The aim of the present randomised study was to find out whether usage of lightweight mesh in inguinal hernia repair, compared with heavyweight mesh, results in decreased incidence of chronic groin pain and foreign body feeling, as well as to evaluate the risk factors for chronic pain development and hernia recurrences.

Methods

The patients were randomised into the heavyweight mesh (HW) group and lightweight mesh (LW) group. A tension-free mesh repair using the Lichtenstein technique was performed on all patients. Pain scores during different activities were measured on visual analogue scale. All patients underwent a clinical examination for any evidence of hernia recurrence.

Results

Of the patients, 17.2?% in the HW group and 29.3?% in the LW group reported that they experienced pain at 3-year follow-up (P?=?0.1323). Pain was most often reported during physical activity. The median VAS score of all studied activities was 30.5 in the HW group and 30.0 in the LW group. There were more patients in the HW group than in the LW group who stated that they could feel the mesh in the groin (27.6 vs. 20.7?%, P?=?0.3967). Among all patients, 42.9?% who had severe pain preoperatively also reported pain during different activities and 19.6?% of the patients who did not have severe pain preoperatively reported pain during different activities (P?=?0.0481). At 3-year follow-up, there was 1 hernia recurrence in the HW group and 1 hernia recurrence in the LW group.

Conclusions

Our study shows that compared with HW mesh, LW mesh has no advantage in reducing chronic groin pain and foreign body feeling at the operation site after inguinal hernioplasty at 3-year follow-up. Severe preoperative pain was correlated with the development of chronic pain. There was no difference between the two study groups in the recurrence rates.     

One-year results of a prospective,randomised clinical trial comparing four meshes in laparoscopic inguinal hernia repair (TAPP)

Background  

A low rate of chronic pain and maximum postoperative comfort are the main goals today in inguinal hernia repair. This four-arm randomised trial compares these parameters after laparoscopic hernia repair (TAPP) with a standard heavyweight mesh (HW), a pure middleweight polypropylene mesh (MW), a lightweight composite polypropylene mesh (LW), or a titanised lightweight mesh (TLW). The primary endpoint of the study was the incidence of chronic pain of any severity at the site of hernia repair at 1 year.     

Randomized clinical trial of lightweight composite mesh for Lichtenstein inguinal hernia repair

BACKGROUND: Almost half the patients who undergo hernia repair with mesh report a feeling of stiffness and a foreign body in the groin. This study evaluated whether patients noticed any difference between lightweight and standard polypropylene mesh for the repair of inguinal hernia. METHODS: Patients scheduled for elective repair of unilateral or bilateral, primary or recurrent inguinal hernia by the Lichtenstein technique were randomized to receive either a conventional densely woven polypropylene mesh (100-110 g/m(2)) or a lightweight composite multifilament mesh (polypropylene 27-30 g/m(2)). Quality of life was assessed using Short Form 36 before operation and 6 months after surgery. Pain was assessed by means of a visual analogue scale 2 days and 6 months after surgery. The primary outcome measure was the feeling of a foreign body in the groin at 6 months. RESULTS: Some 122 hernias were randomized; 117 were included in the analysis of perioperative data, and 106 were re-examined after 6 months. There were no differences between the treatment groups with respect to early and late surgical complications. Use of lightweight mesh was associated with significantly less pain on exercise after 6 months (P = 0.042). In addition, fewer patients reported the feeling of a foreign body after repair with lightweight mesh (17.2 versus 43.8 per cent with conventional mesh; P = 0.003). Quality of life was improved significantly at 6 months compared with the preoperative assessment, and there were no differences between the treatment groups. CONCLUSION: Lightweight polypropylene mesh may be preferable for Lichtenstein repair of inguinal hernia. Larger cohorts with longer follow-up are needed before it can be recommended for routine use.     

Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair

BACKGROUND: Polymer mesh has been used to repair incisional hernias with lower recurrence rates than suture repair. A new generation of mesh has been developed with reduced polypropylene mass and increased pore size. The aim of this study was to compare standard mesh with new lightweight mesh in patients undergoing incisional hernia repair. METHODS: Patients were randomized to receive lightweight composite mesh, or standard polyester or polypropylene mesh. Outcomes were evaluated at 21 days, 4, 12 and 24 months from patient responses to the Short Form 36 (SF-36) and daily activity questionnaires. Complications and recurrence rates were recorded. RESULTS: A total of 165 patients were included in an intention-to-treat analysis (83 lightweight mesh, 82 standard mesh). Postoperative complication rates were similar. The overall hernia recurrence rate was 17 per cent with the lightweight mesh versus 7 per cent with the standard mesh (P = 0.052). There were no differences in SF-36 physical function scores or daily activities between 21 days and 24 months after surgery. CONCLUSION: The use of the lightweight composite mesh for incisional hernia repair had similar outcomes to polypropylene or polyester mesh with the exception of a non-significant trend towards increased hernia recurrence. The latter may be related to technical factors with regard to the specific placement and fixation requirements of lightweight composite mesh.     

Five-year results of a randomized clinical trial comparing a polypropylene mesh with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty

Background

The aim of this study was to assess whether partially absorbable monofilament mesh could influence postoperative pain and recurrence after Lichtenstein hernioplasty over the long term.

Methods

Patients were randomized into two groups that were treated with lightweight (LW) or heavyweight (HW) mesh in 15 centers in Poland. A modified suture technique was used in the lightweight mesh group. Clinical examination was performed. A pain questionnaire was completed five?years after the surgery.

Results

Of the 392 patients who underwent surgery, 161 (90.81?%) of 177 in the HW group and 195 (90.69?%) of 215 in the LW group were examined according to protocol, a median of 62 (range 57–66) months after hernia repair. There was no difference in the recurrence rate (1.9?% LW vs. 0.6?% HW; P?=?0.493). There were 24 deaths in the follow-up period, but these had no connection to the surgery. The patients treated with LW mesh reported less pain in the early postoperative period. After five?years of follow-up, the intensity and the presence of pain did not differ between groups (5 patients in the LW and 4 patients in the HW group). Average pain, (VAS score), was also similar in the LW and HW group (2.25 vs. 2.4) at the fifth year postoperatively.

Conclusion

The use of partially absorbable mesh reduced postoperative pain during the short-term postoperative period. No difference in pain or recurrence rate was observed at 60?months.     

Randomised clinical trial comparing lightweight mesh with heavyweight mesh for inguinal hernioplasty

Purpose  

The aim of the present randomised clinical study was to compare the incidence of post-operative chronic groin pain and the feeling of a foreign body after inguinal hernioplasty with lightweight (LW) and heavyweight (HW) mesh, as well as to evaluate the patient’s quality of life after inguinal hernia repair.     

Randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia

BACKGROUND: The optimum method for inguinal hernia repair has not yet been determined. The recurrence rate for non-mesh methods varies between 0.2 and 33 per cent. The value of tension-free repair with prosthetic mesh remains to be confirmed. The aim of this study was to compare mesh and non-mesh suture repair of primary inguinal hernias with respect to clinical outcome, quality of life and cost in a multicentre randomized trial in general hospitals. METHODS: Between September 1993 and January 1996, all patients scheduled for repair of a unilateral primary inguinal hernia were randomized to non-mesh or mesh repair. The patients were followed up at 1 week and at 1, 6, 12, 18, 24 and 36 months. Clinical outcome, quality of life and costs were registered. RESULTS: Three hundred patients were randomized of whom 11 were excluded. Three-year recurrence rates differed significantly: 7 per cent for non-mesh repair (n = 143) and 1 per cent for mesh repair (n = 146) (P = 0.009). There were no differences in clinical variables, quality of life and costs. CONCLUSION: Mesh repair of primary inguinal hernia repair is superior to non-mesh repair with regard to hernia recurrence and is cost-effective. Postoperative complications, pain and quality of life did not differ between groups.     

Chronic pain after open mesh and sutured repair of indirect inguinal hernia in young males

BACKGROUND: Chronic pain is common after herniorrhaphy, but the effect of surgical technique (mesh versus non-mesh repair) and the social consequences of the pain have not been established. The aim of this study was to analyse chronic postherniorrhaphy pain and its social consequences in young males operated on for an indirect inguinal hernia with a Lichtenstein mesh repair, Shouldice or Marcy (annulorrhaphy) repair. METHODS: This was a postal questionnaire study carried out within the Danish and Swedish Hernia Database Collaboration. Some 2612 patients responded (response rate 80.9 per cent), of whom 1250 had undergone a Lichtenstein, 630 a Shouldice and 732 a Marcy repair. RESULTS: Chronic pain had been experienced within the previous month by 22.9 per cent of the patients who responded. There was an overall decrease in pain with time, from 29.7 per cent at 6-12 months to 18.1 per cent at 37-48 months after surgery, with no overall differences between the three types of repair. Pain was more common in patients younger than 40 years of age. Some 3.9 per cent of patients described the pain as moderate to severe and as frequent or constant. Of all patients with pain, 10.7 per cent experienced it as worse after than before surgery, and 56.6 per cent stated that it interfered with social activities. CONCLUSION: Chronic pain is common after primary inguinal hernia repair in young males, but there is no difference in the pain associated with open mesh and non-mesh repair.     

Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair

BACKGROUND: Two of the most commonly used open prosthetic tension-free techniques for inguinal hernia repair are Lichtenstein's operation and the mesh plug repair. The technique of choice remains a subject of ongoing debate. The objective of the present investigation was to compare the two surgical procedures with respect to associated morbidity and recurrence rates. METHODS: Five hundred and ninety-five patients with 700 primary or recurrent inguinal hernias were randomized to undergo either Lichtenstein's operation or mesh plug repair. The primary endpoint of the investigation was the recurrence rate 1 year after surgery. Secondary endpoints were perioperative complications and reoperation rates. RESULTS: At 12-month follow-up, 597 hernia repairs (85.3 per cent) were evaluated. There were no significant differences regarding recurrence rates and perioperative complications. However, there was a significant difference in the overall reoperation rate between the two treatment groups, with 13 reoperations (4.2 per cent) in the Lichtenstein group and four (1.4 per cent) in the mesh plug group (P = 0.047). CONCLUSION: Lichtenstein's operation and the mesh plug repair are comparable with respect to perioperative complications and recurrence rates.     

轻量型网片和普通聚丙烯补片在腹股沟疝修补术中的对比研究

目的探讨轻量型网片（强生UPP）在腹股沟疝无张力修补中的作用。方法回顾分析90例次腹股沟疝无张力修补患者的临床资料,其中47例次行普通聚丙烯材料修补,43例次行强生UPP修补。结果强生UPP修补组与普通聚丙烯材料修补组比较,早期并发症发生率（切口疼痛、切口积液、伤口感染、肺部感染、尿道损伤以及尿潴留等）和住院时间差异无统计学意义。在6个月时强生UPP修补组其局部切口疼痛、异物感的患者明显少于普通聚丙烯材料修补组,腹壁顺应性明显好于普通聚丙烯材料修补组,在6个月时两组均没有复发。结论轻量型网片在腹股沟疝无张力修补中,其后期并发症明显减少,有望成为腹股沟疝无张力修补的首选材料。     

Totally extraperitoneal endoscopic repair of recurrent inguinal hernia.

BACKGROUND: Conventional repair of recurrent inguinal hernia is associated with a re-recurrence rate as high as 35 per cent. Endoscopic mesh repair has promising results regarding both recurrence and complication rates. METHODS: In a retrospective review, the results of endoscopic totally extraperitoneal repair were evaluated in 104 patients with 108 recurrent hernias. Follow-up was at least 1 year. Type of recurrence, time of occurrence after previous repair, duration of surgery, complications, duration of hospital stay and number of re-recurrences were evaluated. RESULTS: Follow-up ranged from 12 to 29 (mean 16) months. Forty-three recurrences were direct, 41 indirect and 15 combined; one was a femoral hernia. Median time to previous operation was 36 months (range 8 days to 42 years). Median duration of surgery was 63 (range 25--160) min. While there were no complications during operation, 12 patients (12 per cent) had a postoperative complication. Two direct re-recurrences (2 per cent) occurred as a result of inadequate positioning of the prosthetic mesh. CONCLUSION: The endoscopic totally extraperitoneal technique is safe and effective for the repair of recurrent inguinal hernia.     

轻量型和重量型补片在腹股沟疝修补术后慢性疼痛的临床对照研究

【摘要】 目的 比较使用轻量型或重量型网片进行腹股沟疝修补术后的疗效。方法 2008年10月至2010年10月间,我院对120例腹股沟疝病人,行Lichtenstein疝修补术,病人分成2组,一组使用轻量型(Ultrapro,30 g/m2)(LW)补片,另一组使用重量型网片(Prolene, 100 g/m2)(HW)。通过患者接受临床检查及疼痛问卷调查获得随访数据。术后早期及远期均对病人进行随访,以评估术后慢性疼痛及不适感的差异。结果 平均随访12个月,两组均未发现复发病例,与重量型补片相比,轻量型网片组患者随访检查时的疼痛较轻,各种腹股沟问题较少,且较少有异物不适感。结论 Lichtenstein疝修补术中使用轻量型网片可以改善术后的疼痛和不适感。术后12个月运动时疼痛的比例也降低(P<0.05);腹股沟区有异物不适感的病人较少。     

Randomized trial comparing the Prolene Hernia System, mesh plug repair and Lichtenstein method for open inguinal hernia repair

BACKGROUND: Most surgeons favour the use of a mesh for open inguinal hernia repair as it has a low recurrence rate. Procedures used most frequently are the Lichtenstein method, mesh plug repair and the Prolene Hernia System. The choice of technique may be influenced by the effects on postoperative pain and quality of life. METHODS: A total of 334 patients were allocated blindly and at random to receive one of these three meshes for open hernia repair. Quality of life was assessed with the Short Form 36 and pain by a visual analogue scale 14 days, and 3 and 15 months after surgery. RESULTS: Operative complications were rare and comparable between the groups. Long-term follow-up was completed by questionnaire in 95.8 per cent of patients. There were no significant differences in pain parameters between the three meshes; overall, 43.3 per cent of patients reported some form of groin pain. The severity of the chronic pain correlated with a higher pain score in the first 2 weeks after surgery (P < 0.001). A significant reduction in scores for role emotional (short term) and vitality (long term) quality of life domains was found in patients who had a Lichtenstein repair. CONCLUSION: These short- and long-term results did not show any clinically significant difference in postoperative pain and quality of life between the three types of mesh hernia repair. Severe early postoperative pain reliably predicted the likelihood of persisting chronic groin pain.     

Risk of recurrence 5 years or more after primary Lichtenstein mesh and sutured inguinal hernia repair

BACKGROUND: The risk of recurrence of inguinal hernia within 5 years of repair is lower after mesh than sutured repair in men, but no large-scale studies have compared the risk of recurrence beyond 5 years. METHODS: The Danish Hernia Database prospectively collects data on almost all primary inguinal hernia repairs in men (older than 18 years). This study used data recorded over 8 years, analysing reoperations for recurrent hernia in the intervals 0-30 months, 30-60 months and 60-96 months after operation. RESULTS: The reoperation rate was significantly lower after Lichtenstein open mesh repairs than open sutured repairs (Cox hazard ratio (HR) 0.45 (95 per cent confidence interval (c.i.) 0.39 to 0.51) for 0-30 months after surgery; HR 0.38 (95 per cent c.i. 0.29 to 0.49) for 30-60 months). In 13 674 primary inguinal hernia repairs with an observation interval of 5 years or more, the risk of reoperation after Lichtenstein repair was a quarter of that after sutured repair (HR 0.25 (95 per cent c.i. 0.16 to 0.40) for 60-96 months after surgery). After 5 years, the reoperation rate increased continuously after sutured repair but not after mesh repair. CONCLUSION: Lichtenstein mesh repair for inguinal hernia prevented recurrence beyond 5 years after the primary operation, but sutured repair did not.     

Prospective nationwide analysis of laparoscopic versus Lichtenstein repair of inguinal hernia

BACKGROUND: According to a Cochrane review, laparoscopic inguinal hernia repair compares favourably with open mesh repair, but few data exist from surgical practice outside departments with a special interest in hernia surgery. This study compared nationwide reoperation rates after laparoscopic and Lichtenstein repair, adjusting for factors predisposing to recurrence. METHODS: Some 3606 consecutive laparoscopic repairs were compared with 39 537 Lichtenstein repairs that were prospectively recorded in a nationwide registry between 1998 and 2003. Patients were subgrouped according to type of hernia: primary or recurrent and unilateral or bilateral. Overall reoperation rates and 95 per cent confidence intervals were calculated. Long-term reoperation rates were estimated using the Kaplan-Meier method. RESULTS: The overall reoperation rates after laparoscopic and Lichtenstein repair of unilateral primary indirect hernia (0 versus 1.0 per cent), primary direct hernia (1.1 versus 3.1 per cent), unilateral recurrent hernia (4.6 versus 4.8 per cent) and bilateral recurrent hernia (2.6 versus 7.6 per cent) did not differ. However, laparoscopic repair of a bilateral primary hernia was associated with a higher reoperation rate than Lichtenstein repair (4.8 versus 3.0 per cent) (P = 0.017). CONCLUSION: Laparoscopic repair compared favourably with Lichtenstein repair for primary indirect and direct hernias, and unilateral and bilateral recurrent hernias, but was inferior for primary bilateral hernias.     

Prospective randomized trial of polypropylene mesh compared with nylon darn in inguinal hernia repair.

BACKGROUND: The main aim of this study was to evaluate outcome in patients undergoing open inguinal hernia repair with either polypropylene mesh or nylon darn. METHODS: This was a randomized prospective trial of patients who underwent the procedure with follow-up at 1 week, 6 weeks and 1 year. RESULTS: One hundred men underwent 105 repairs by consultant surgeons and registrars; there were 54 mesh and 51 nylon repairs. Demographics in both groups were similar at the start of the trial, as were the types of hernia. The pain scores at 24, 48 and 72 h were similar, as was the duration of analgesia requirement. There were no differences in early or late complications. Return to normal activity in each group was also similar, with a mean time of 5 weeks. The recurrence rate in both groups was comparable: 4 per cent after mesh repair and 4 per cent after darn repair at 1-year review. CONCLUSION: Open inguinal hernia repair with a nylon darn was equivalent to polypropylene mesh with respect to early measures of postoperative outcome and recurrence at 1 year.     

Attendance at a pain clinic with severe chronic pain after open and laparoscopic inguinal hernia repairs

BACKGROUND: The aim was to compare the frequency of severe chronic pain that required attendance at a pain clinic after open and laparoscopic inguinal hernia repairs. METHODS: This was a retrospective analysis of 7999 patients who underwent inguinal hernia repair between January 1994 and December 2001. The definition of severe chronic pain was pain related to inguinal hernia surgery that was bad enough for the patient to seek further medical help and be referred to the specialist pain clinic after exclusion of surgically correctable pathology such as hernia recurrence. RESULTS: During the study there were 7153 open repairs and 846 laparoscopic repairs. Sixty-nine patients (1.0 per cent) were referred to the pain clinic a median of 16.9 (range 5.1-69.4) months after open hernia repair. Three patients (0.4 per cent) were referred a median of 16.5 (range 7.3-21.5) months after laparoscopic hernia repair (P = 0.045). CONCLUSION: Laparoscopic inguinal hernia repair was associated with a significantly lower frequency of attendance at the pain clinic with severe chronic pain.     

Is postoperative chronic pain syndrome higher with mesh repair of inguinal hernia?

Chronic postoperative pain has been associated with mesh repair in meta-analysis of clinical trials. We compared the incidence of early complications, recurrence, and chronic pain syndrome in anatomic and mesh repairs in 200 patients. We defined chronic pain syndrome as pain in the inguinal area more than 3 months after inguinal hernia repair, patient referral to pain management, or necessity of a secondary procedure for pain control. The mean follow-up time was 4 years and 2 months for anatomic repair and 3 years and 7 months for mesh repair. The clinical outcomes did not reveal a significant disparity between the 100 consecutive patients who had mesh repair versus the 100 patients who had anatomic repair with regard to the incidence of superficial wound infection (0 vs. 2%, P = 0.497), testicular swelling (12 vs. 7%, P = 0.335), hematoma (1 vs. 0%, P = 0.99), recurrence (3 vs. 2%, P = 0.99), or chronic postoperative pain (4 vs. 1%, P = 0.369). The anatomic procedure without mesh should continue to be offered to patients who have an initial inguinal hernia repair.