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.     

Randomized clinical trial of mesh versus non-mesh primary inguinal hernia repair: long-term chronic pain at 10 years

BACKGROUND: Open mesh or non-mesh inguinal hernia repair may influence the incidence of chronic postoperative pain differently. METHODS: A total of 300 patients scheduled for repair of a primary unilateral inguinal hernia were randomized to non-mesh or mesh repair. The primary outcome measure was clinical outcome including persistent pain and discomfort interfering with daily activity. Long-term results at 3 years of follow-up have been published. Included here are 10-year follow-up results with respect to pain. RESULTS: Of the 300 patients, 87 patients (30%) died and 49 patients (17%) were lost to follow-up. A total of 153 were physically examined in the outpatient clinic after a median long-term follow-up of 129 months (range, 109 to 148 months). None of the patients in the non-mesh or mesh group suffered from persistent pain and discomfort interfering with daily activity. CONCLUSIONS: Our 10-year follow-up study provides evidence that mesh repair of inguinal hernia is equal to non-mesh repair with respect to long-term persistent pain and discomfort interfering with daily activity. An important new finding from the patient's perspective is that chronic postoperative pain seems to dissipate over time.     

Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia

OBJECTIVE: The objective of this study was to determine the best treatment of incisional hernia, taking into account recurrence, complications, discomfort, cosmetic result, and patient satisfaction. BACKGROUND: Long-term results of incisional hernia repair are lacking. Retrospective studies and the midterm results of this study indicate that mesh repair is superior to suture repair. However, many surgeons are still performing suture repair. METHODS: Between 1992 and 1998, a multicenter trial was performed, in which 181 eligible patients with a primary or first-time recurrent midline incisional hernia were randomly assigned to suture or mesh repair. In 2003, follow-up was updated. RESULTS: Median follow-up was 75 months for suture repair and 81 months for mesh repair patients. The 10-year cumulative rate of recurrence was 63% for suture repair and 32% for mesh repair (P < 0.001). Abdominal aneurysm (P = 0.01) and wound infection (P = 0.02) were identified as independent risk factors for recurrence. In patients with small incisional hernias, the recurrence rates were 67% after suture repair and 17% after mesh repair (P = 0.003). One hundred twenty-six patients completed long-term follow-up (median follow-up 98 months). In the mesh repair group, 17% suffered a complication, compared with 8% in the suture repair group (P = 0.17). Abdominal pain was more frequent in suture repair patients (P = 0.01), but there was no difference in scar pain, cosmetic result, and patient satisfaction. CONCLUSIONS: Mesh repair results in a lower recurrence rate and less abdominal pain and does not result in more complications than suture repair. Suture repair of incisional hernia should be abandoned.     

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: a prospective randomized controlled trial

BACKGROUND: This study was designed to compare an open tension-free technique (Lichtenstein repair) with a laparoscopic totally extraperitoneal hernia repair (TEP). METHODS: One hundred sixty-eight men aged 30 to 65 years with primary or recurrent inguinal hernia were randomized to TEP or open mesh technique in the manner of Lichtenstein. Follow-up was after 1 and 6 weeks, and 1 year. RESULTS: Eighty-one patients were randomized to TEP, and 87 to open repair. For 1 patient in each group, the operation was converted to a different type of repair. No difference was seen in overall complications between the 2 groups. However, 1 patient in the TEP group underwent operation for small bowel obstruction after surgery. A higher frequency of postoperative hematomas was seen in the open group (P <.05). Patients in the TEP group consumed less analgesic after surgery (P <.001), returned to work earlier (P <.01), and had a shorter time to full recovery (P <.01). Two recurrences occurred in the TEP group 1 year after surgery. CONCLUSION: The TEP technique was associated with less postoperative pain, a shorter time to full recovery, and an earlier return to work compared with the open tension-free repair. No difference was seen in overall complications. However, 2 recurrences did occur after 1 year in the TEP group.     

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.     

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.     

Laparoscopic extraperitoneal repair versus open inguinal hernia repair: 20-year follow-up of a randomized controlled trial

Purpose

This study compared the long-term recurrence rates of laparoscopic totally extraperitoneal (TEP) and open inguinal hernia repair in patients from a randomised trial completed in 1994. Laparoscopic inguinal hernia surgery, especially TEP repair, has gained widespread acceptance in recent years. There is still paucity of data on long-term follow-up comparing recurrence rates for open and laparoscopic techniques. This is the first study providing direct long-term comparative data about these techniques.

Methods

A randomised controlled trial was conducted between 1992 and 1994 on patients undergoing a laparoscopic TEP or an open inguinal hernia (Shouldice) repair at our institution. Of the original 104 participants, contemporary follow-up data could be obtained for 98 patients with regards to long-term recurrence. These data were collected with the help of questionnaires, telephone calls and retrieval of case records. Medical records were reviewed for all patients. Data were analysed using a Cox proportional hazards model.

Results

There were 7/72 (9.7%) recurrences in the open group and 9/35 (25.7%) recurrences in the laparoscopic group. This difference in recurrence rates was statistically significant (HR = 2.94; 95% CI 1.05–8.25; p = 0.041.)

Conclusion

Laparoscopic TEP inguinal hernia repair performed in 1992–1994 had a higher recurrence rate than open Shouldice inguinal hernia repair during the same period. The original study was undertaken in the inceptive days of laparoscopic surgery and results need to be interpreted considering the technology and expertise available at that time.

     

Comparison between modern mesh and conventional non-mesh methods of inguinal hernia repair

BACKGROUND: The objectives of the study were to compare the tension-free mesh repair with non-meash conventional repair of groin hernia. METHODS: In the past two years in 299 consecutive unselected patients 339 inguinal hernia repairs were carried out. They randomly allocated to undergo either a non-meash modified Bassini's repair (n=164) or a tension-free mesh repair (n=175). The latter group consisted of laparoscopic TAPP repair (n=46) and open onlay patch repair (n=64) or plug and patch repair (n=65). Operation time, postoperative pain and complications, hospital stay, return to work and recurrence were assessed. Statistical analysis was made using the "t"-Student test. RESULTS: The characteristics of the patients in each group and the operation time did not differ significantly. The planned procedure was completed in all and no death occurred. The analgesic requirements (none 2.5 vs 56.4%, opiods 77 vs 23.6%), complication rate (9.4 vs 4.3%), hospital stay (4.2 vs 1.8 days), return to work (17.2 vs 7.3 days) and recurrence rate (5.5 vs 1.2%) in non-mesh group were more than in the mesh group. All differences were statistically significant (p<0.05). Among the three subgroups of mesh group no statistically significant differences (p>0.05) were found. CONCLUSIONS: The tension-free mesh repair either open or laparoscopic provides excellent results with better short-term outcome and lower recurrence rate than non-mesh modified Bassini's repair.     

Sixty-month follow-up after endoscopic inguinal hernia repair with three types of mesh: a prospective randomized trial

Background  This prospective, clinical, randomized, double-blind study was intended to investigate the impact of the structure and the amount of polypropylene (PP) mesh used in laparoscopic transabdominal preperitoneal hernioplastic (TAPP) on physical function and life quality. Methods  180 male patients with primary inguinal hernia undergoing TAPP were randomized for using a heavyweight (108 g/m²), double-filament PP mesh (Prolene, 10 × 15 cm, group A, n = 60), a multifilament, heavyweight variant (116 g/m²) of PP mesh (Serapren, 10 × 15 cm, group B, n = 60), or a composite mesh (polyglactin and PP) (Vypro II, 10 × 15 cm, group C, n = 60). We compared in terms of complications (seromas, recurrence rate) and life quality (pain development, physical function). The development of life quality was documented according to the SF-36 Health Survey. The follow-up period was 60 months. Results  The recurrence rate (2.2% overall) during 60-month follow-up was not significantly different between the groups. Convalescence in group A was slower than in groups B and C: mean-term values of the visual scales for pain development were significantly (p < 0.05) higher, incapacity for work was 8.2 days longer, and urological adverse effects were stronger. The mean-term development of life quality was significantly lower in group A up to 12th week postoperatively. There were no significant differences between groups B and C. Beyond the 12th postinterventional week the differences diminished. Conclusions  The composite mesh does not provide an advantage concerning physical function or pain development in comparison to the multifilament, heavyweight, pure polypropylene mesh. Independently of which mesh was implanted 5% of patients are still suffering from discomfort after 5 years.     

Randomized clinical trial comparing lightweight or heavyweight mesh for mesh plug repair of primary inguinal hernia

Background

The aim of this study was to assess whether the application of a lightweight mesh for mesh plug repair (MPR) for primary inguinal hernia could reduce chronic pain or other symptoms associated with the insertion of the prosthesis.

Methods

Patients over 20 years of age with a unilateral primary inguinal hernia were eligible to participate in the study. The patients were randomly assigned to a lightweight mesh (LWM) or a heavyweight mesh (HWM) group. All the operations were performed under local anesthesia. The operative details, including the hernia type and the nerves that were identified, and the postoperative complications were recorded. All follow-up and outcome measures were obtained based on a physical examination and a questionnaire regarding pain and other symptoms at 1 week, 1, 3, 6, and 12 months after the surgery in a double-blinded manner.

Results

The use of LWM significantly reduced foreign body sensation after 12 months to one-third of the incidence reported for the use of HWM (5.8 vs. 17.9 %; P = 0.013), while no significant differences were found in pain parameters, including the use of pain relief medications, between the groups throughout the study period.

Conclusion

This study indicated that the use of LWM in the MPR decreases the incidence of foreign body sensation at 1 year after surgery for primary inguinal hernia. LWM may be preferable to MPR, similar to results described previously for Lichtenstein repair.     

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.     

The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair

Purpose  

Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain.     

A cost-effectiveness analysis of tension-free versus shouldice inguinal hernia repair: a randomized double-blind clinical trial

Background  The use of open tension-free techniques in hernia surgery seems to be superior to those techniques that apply tension to the suture line. However, the cost-effectiveness of tension vs. tension-free repairs has not been investigated before. Methods  This study is a cost-effectiveness analysis within a randomized controlled clinical trial that compared open-tension (OT) versus mesh-plug tension-free (MPTF) hernia repair, with a 2-year follow-up for each patient. Between July 2002 and June 2003, 106 patients with inguinal hernia were randomized to either procedure. Main outcome measures included average surgical time, time to full recovery, pain visual analog scale, amount of analgesics required, off-work time, hospital stay, and heath-care costs. Results  The average cost was $885.15 (95% CI $843.56–$926.74) and $837.66 (95% CI $796.42–878.89) USD for the OT and the MPTF herniorrhaphy, respectively (P < 0.05). Average yearly savings with the MPTF repair were calculated as $7,598.84 USD. Surgery time, time to full recovery, pain visual-analog scale, use of analgesics, off-work time, and hospital stay were significantly lower for the MPTF repair. Disability-adjusted life-years were reduced 56% with the MPTF repair, which represented a total savings of $12,656.60 USD with this procedure. Conclusion  This controlled clinical trial demonstrates that the MPTF technique significantly decreases care costs in patients operated on for inguinal hernias.     

Randomized clinical trial of laparoscopic versus open inguinal hernia repair

BACKGROUND: Several studies have suggested that better results are obtained after laparoscopic repair of inguinal hernia than after conventional operation. This is most obvious for bilateral and recurrent hernias but less accepted for primary unilateral hernias. METHODS: This was a randomized clinical trial comparing transabdominal preperitoneal laparoscopic repair with the Shouldice technique in patients with primary unilateral hernia. Some 138 patients were randomized to laparoscopic hernia repair and 130 to open surgical repair. RESULTS: The complication rates in the two groups were similar. In the laparoscopic group the patients returned to work more rapidly with a median time of 13 versus 18 days (P < 0.005) and had a shorter period of analgesia intake with a median time of 2.1 versus 2.7 days (P < 0.02). The follow-up was 97.8 per cent complete. At a median of 12 months, four recurrences (2.9 per cent) were detected in the laparoscopic group and three (2.3 per cent) in the open group. CONCLUSION: This study shows that in patients with a primary unilateral hernia laparoscopic repair results in less postoperative pain and a quicker recovery than open repair.