Khartoum Medical Journal (2008) Vol. 01, No. 03, pp.

133 -139

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Comparison between tension-free mesh and sutured repair in inguinal hernias

Saleh A Bin Tayair and Yahia A Al-Arabi*
Department of Surgery, Faculty of Medicine, University of Khartoum

Abstract Objective: The objective of this study is to compare the outcome of tension-free mesh and sutured repair in inguinal hernias. Patients and methods: A randomized controlled study of 403 patients with primary inguinal hernias has been conducted at two main hospitals in Hadhramout-Yemen, between September 2004 and December 2007. The patients were randomly allocated to either mesh or sutured repair, and assessed at regular intervals for a period of three years regarding hernia recurrence, operative time, patients comfort, analgesia required, hospital stay, rehabilitation, satisfaction, and complications. Results: The recurrence rate was 1.5 % in the mesh repair group and 10.5 % in the sutured repair group. The difference was statistically significant, p < 0.001. The pain score and analgesic consumption were significantly greater in the sutured group than in the mesh group. The time to return to normal and social activities was earlier (16 days, vs. 19.8 days), and the patients expressed more satisfaction with the procedure (94.5% vs. 60.7%) in the mesh group than in the sutured group. The operative time (45.6 minutes, vs. 43.4 minutes), hospital stay (1.83 days vs. 2.6 days) and complications were comparable in both treatment groups, except that chronic pain was significantly more in the sutured group (12.4 % vs. 4%). Conclusion Tension-free mesh repair has shown superiority over sutured repair with regard to recurrence rate, post-operative pain, consumption of analgesic medications, rehabilitation and patient satisfaction with the procedure. Introduction Inguinal hernia repair is a frequent operation performed by the general surgeon worldwide(1,2). Numerous methods have been described over the years to try to improve on the hernia surgery. Tissue repair is associated with undue tension at the suture line, which leads to a higher rate of recurrence, up to 15% in most series(3,4,5). Mesh repair is promising(6,7), but most studies were either: retrospective, case series, of small sample size, or short follow-up(8-11). Over all, in Yemen, Sudan, and probably North Africa & Arab States sutured repair is still the standard method practiced by 68.2% of surgeons. Mesh repair is restricted to huge or recurrent hernias(12). The aim of this study is to clinically evaluate the outcomes of tension-free mesh, and sutured repairs, in primary inguinal hernias in the hands of general surgeons. Patients & methods This is a prospective randomized controlled study, *Corresponding author: Department of Surgery, Faculty of Medicine, University of Khartoum carried out on 403 patients having primary inguinal hernias at Ibn Sina Central Teaching hospital and Al-Amal Specialized Hospital, Hadhramout, Yemen, between September 2004 and December 2007. The patients were randomly allocated to either mesh Lichtenstein(13) repair, or sutured Modified Bassini(14) repair in a ratio 1:1. Any patient above 18 years, who presented with clinically diagnosed inguinal hernia, fit to receive spinal anaesthesia, and gave informed consent, was included in the study. Exclusions were previous hernia repair, American Society of Anesthesiology score 1V or V, emergency operation, morbid obesity and severe local or systemic infection. The study protocol was studied and approved by the ethical committee of the Faculty of Medicine, University of Hadhramout and by the Research committee of the Faculty of Medicine, University of Khartoum. The study was explained to the patient in details, who gave an informed consent. The participating Surgeons were classified according to the years of experience into three levels: Level 1;

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< 5 years, Level 11; 5-12 years, and Level 111; more than 12 years. The primary outcome measure was hernia recurrence. The secondary outcome measures were operative time, technical difficulty, length of post-operative hospital stay, intra-operative and postoperative complications, pain, analgesia required, time of return to usual normal activities, and patients satisfaction to surgery. The operated patients were assessed at 1, 2, 4, and 12 weeks, and 1, 2, 3 years after surgery. Spinal anaesthesia has been chosen as the method of choice. All patients received I/V single dose of prophylactic ceftriaxone I gram pre-operatively at the induction of anaesthesia. The Mesh Technique Through the classical inguinal incision, the hernial sac was dealt with as usual. The plane between the external oblique aponeurosis and conjoint tendon was opened up as widely as possible. A polypropylene mesh (Prolene, Dyna-Mesh, Germany) measuring 7.5cm.x15cm was trimmed to fit this space. The inferio-medial corner of the mesh was fixed to the anterior rectus sheath where it is inserted into the pubic bone, not less than 2cm medial to the pubic tubercle. The lateral edge of the mesh was sutured to the inguinal ligament using loose, continuous, 2/0 prolene suture. A slit was made on the lateral end of the mesh for 5 cm creating two tails 2/3 above, 1/3 below to accommodate the cord. The upper tail was then placed superficial and sutured to the inguinal ligament with one or two interrupted sutures. Three or four sutures were used to fix the mesh superiorly. Care was taken to keep the mesh slightly relaxed, to compensate for increased intra-abdominal pressure when the patient stands up from the recumbent position, and to compensate for the future shrinkage of the mesh. Data analysis All data were analyzed using SPSS for Windows, version 14 (SPSS Inc., Chicago, IL). Analyses of the differences between continuous, normally distributed data were expressed as means s.d., using twotailed t-test. Percentages were compared with the use of Chi-Square test. The cumulative percentage of patients with recurrence over time was calculated with Kaplan-Meier curve and compared with logrank test. Pain score for the two groups of repair at different intervals, was compared with the use of an analysis of variance. Multivariate analysis of various factors of hernia recurrence was performed by using Cox regression test. Results The demographic characteristics of patients and hernias & the prognostic factors of hernia recurrence were comparable in the two groups of repair (See Table 1).

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Table 1: Descriptive data for the characteristics of patients with inguinal hernias according to allocated method of repair

Type of repair Characteristics Sex n. (%) Male Female Age (yrs.) meansd. BMI meansd. Clinical presentation: Preop. swelling Duration of hernia External diameter Preoperative pain Irreducibility Type of hernia: Direct Indirect Side of hernia: Right Left Bilateral Pre-op. risk factors Chronic constipation Chronic cough Prostatism Diabetes mellitus Bronchial asthma Smoking Steroid use Heavy manual activity Under weight Obesity Urethral stricture Sutured (n = 201) 182 (90.5%) 19 (9.5 % ) 50.3 15.6 24.0 8.4 196 (97.5%) 47.9 43.1 months 6.28 1.75 cm. 55 (27.4%) 16 (8.0 % ) 96 (47.8%) 105 (52.2%) 129 (64.2%) 60 (29.8%) 12 (6.0 % ) 27 (13.4%) 27 (13.4%) 22 (10.9%) 18 (8.9 % ) 13 (6.5 % ) 116 (57.7%) 11 (5.5 % ) 73 (36.3%) 25 (12.4%) 19 (9.5 % ) 1 (0.5 % ) Mesh (n = 202) 18 4 (91.1%) 18 ( 8.9% ) 49.5 15.5 23.5 4.8 201 (99. 5%) 54.2 37.9 months 6.41 2.11 cm. 60 (29.7%) 19 (9.4 % ) 94 (46 5%) 108 (53.%5) 132 (63.4%) 57 (28.2%) 13 (6.4 % ) 29 (14.4%) 30 (14.9%) 22 (10.9%) 16 (7.9 % ) 13 (6.5 % ) 110 (54.5%) 13 (6.4 % ) 79 (39.1%) 27 (13.4%) 21 (10.4%) 2 (1.0 % )

Plus minus values are means standard deviation. Values in parentheses are Percentages. BMI: denotes Body Mass Index The 3-year cumulative rate of recurrence was 1.5 % (n=3) for patients who underwent mesh-repair, and 10.5% (n=21) for those who underwent sutured-repair. The difference was statistically significant (p<0.001 by log rank test) (See Fig.1).

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Figure 1: Kaplan-Meier Curves for non-recurrence of hernia after repair of primary inguinal hernias according to whether the patient was assigned to sutured repair (n=201) or mesh repair (n=202)

The results of multivariate analysis of the prognostic factors of hernia recurrence, identified sutured repair (p=0.001), junior surgeon (p=0.001), wound infection (p=0.01) as independent predictors for inguinal hernia recurrence are given in Table 2.
Table 2: Multivariate analysis of prognostic factors for recurrence in inguinal hernia repairs

Variables Sutured repair Junior surgeon Wound infection

P value 0.001 0.001 0.01

HR** 7.32 4.4 3. 11

95% CI of HR 2.63 16.24 3.15 5.18 2.924.7

HR**: Hazard ratio. 95% CI : 95 percent confidence interval. Multivariate analysis was performed by Cox- regression test. The relative hernia recurrence of each level of surgeons, in the sutured and mesh repairs of inguinal hernias is illustrated in Figure 2; With Level 1 surgeons, the recurrence rate was 6.5% in the mesh group, and 1% in the sutured group, while with L 111, it was 1.5% in the sutured group and 0.5% in the mesh group%. The difference is statistically significant. Furthermore, with L11 the recurrence rate is 2.5% in the sutured group, and 0.5% in the mesh group, indicating recurrence rate is high with the young surgeons, and tends to fall with the years of experience.

Figure 2: Relative hernia recurrence of each level ( surgeon experience) in the sutured and mesh repairs of inguinal hernias

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Pain score after surgical repair, from the day of surgery up to 3 months, seemed to be significantly greater in the sutured group, than in the mesh group. The difference was statistically significant, (p< 0.001( (See Figure 3 below).

Figure 3: Pain score following patients with inguinal herniorraphy with either suture or mesh

Mean ( s.d.) pain score on D0 (day of surgery), D1 (1st. post-operative day), D7 (7th. Post-operative day), D14 (14th post-operative day) and D30 (30th post-operative day). The proportions of patients who required pethidine injection in the mesh group was 20.3% compared with 51.2% in the sutured group, p<0.001. Similarly, the proportions of patients who required oral analgesia (50 mg diclophenac Na tab.) in the mesh and sutured repair groups were 36.6% and 68.6% respectively. The mean duration of analgesic use was 1.18 weeks for the sutured group comparable with 0.5 week for the mesh group p <0.001 (See Figure 3). The time to return to normal activities was significantly shorter in the mesh group (16.2 8.3 days) as compared to the sutured group (20.8 11.3 days), which was statistically significant, p<0.001. Overall, at three month-visit, the patients who had mesh repair were significantly more satisfied with the procedure (94.5%) than those who had sutured repair (60.7%), p<0.001. Finally, the mean operative time (45.610.9 min. vs. 43.1 10.8min.), hospital stay (1.9 0.80 vs. 2.090.78), and complications were comparable in both groups, except for chronic post-operative pain which was found to be significantly greater in the sutured repair group than in the mesh group, (4% vs.12.4%, p<0.001 ( Table 3).
Table 3: Intra-operative and post-operative complications in the two treatment groups of inguinal hernia repairs

Type of repair Complication Sutured (n=201) Mesh (n=202)

P value

Intra-operative 7 (3.5 %) 7 (3.5 %) Nerve injury 4 (2.0 %) 6 (3.0 %) >0.05 Epigastric artery injury 1 (0.5 %) 1 (0.5 %) >0.05 Vas injury 1 (0.5 %) 0 (0.0 %) >0.05 Minor bladder injury 1 (0.5 %) 0 (0.0 %) >0.05 Early postoperative 37 (18.4%) 40 (19.8%) Urinary retention 14 (7.0 % ) 12 (5.9 %) >0.05 Haematoma 3 (1.5 % ) 2 (1.0 %) >0.05 Seroma 1 (0.5 % ) 2 (1.0% ) >0.05 Wound infection 5 (2.5 % ) 6 (3.0% ) >0.05 Local numbness 8 (4.0 % ) 10 (5.0 %) >0.05 Scrotal oedema 4 (2.0 % ) 5 (2.5% ) >0.05 Hydrocele 2 (1.0 % ) 3 (1.5 %) >0.05 Late post-operative 34 (16.9%) 18 (8.9 %) Testicular atrophy 1 (0.5 % ) 0 (0.0 % ) >0.05 Chronic infection 1 (0.5 % ) 2 (1.0 % ) >0.05 Chronic groin pain 20 (12.4%) 8 (4.0 % ) <0.001 Chronic constipation 1 (0.5 % ) 2 (1.0 % ) >0.05 Persistent numbness 5 (2.5 % ) 6 ( 3.0 %) >0.05 Intestinal obstruction 1 (0.5 % ) 0 (0.0 % ) >0.05 Total 78 (38.8%) 65(32.2%) >0.05 Values in parenthesis are percentages of patients. P < 0.05 is significant

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Discussion Abdominal wall hernia is a common clinical problem treated by the general surgeon today. There is a local defect which has to be closed technically, either by sutures(2,3) or, in modern times, with meshes(7,15) . It is reported that sutured technique is still one of the preferred surgical options of hernia repair in hospitals all over the developing world(16). The impact of the type of repair, with or without mesh, on recurrence rate is still an object of debate. In the sutured repair of the present study, the attempt to approximate the conjoined tendon to the inguinal ligament is a cause of unavoidable tension and pulling along the suture line, causing additional pain, prolonged recovery period, and high rates of recurrence(2,3,4). This high rate of recurrence has been reduced to a minimum (10.5% vs. 1.5%) by adopting tension-free technique with polypropylene mesh material. Polypropylene mesh can be quickly fused by the fibroblastic reaction, setting up scaffolding that in turn induces the synthesis of collagen, and allows the formation of a new resistant wall which withstands the rising abdominal pressure extended by the abdominal content once the patient strains(8). So, defects of any size can be closed easily without the pulling and tension which are produced by the sutured repair, and this may help in reducing the rate of recurrence and intensity of postoperative pain and promoting early return to social activities(9). In contrast to the sutured repair, mesh repair was found to be as a protective factor against hernia recurrence. This is in accordance with results suggested in previous trials comparing the same techniques(9,10,12). The 1.5% recurrence rate in mesh repair of inguinal hernias, in the present study, was comparable to that of Alam, et al (1.2%)(7) , Choudy et al (1.2%)(17), and Farooq & Rehman (1.5% )(18). Other authors like Butters et al(19) and Sakorafas et al(20) with large series showed a recurrence rate of less than 1%. In the present study, the junior surgeons were initially supervised directly by experienced surgeons and asked to follow the standard described techniques. Although not directly recorded, the general impression was that the learning curve was short and efficiency was rapidly attained. Similar findings described in the study of Chan et al(21) found that trainee surgeons acquired the skills easily. It may be argued that a group of surgeons, who are interested in a particular procedure, will always perform better than those who dont have this surgical interest. This is confirmed by the results of this study, in which more than half of the recurrences followed operations done by the junior surgeons. These findings clearly demonstrated that most hernia recurrences, especially the early ones, are the result of technical error by the surgeon, and that is why fewer recurrences occurred in hernia specialized centres in which the surgeons were confined in their practice to hernia repair. This is in accordance with other studies(22,23).

Wound infection historically has been associated with an increased recurrence rate(22). In the present study, mesh repair was not associated with greater infection than sutured repair (3% vs. 2.5%). Data from published series did not support the contention that infection is more common in open mesh repair of hernias as compared with sutured repair(24).Thrill and Hopkins(25), found 0.54% versus 1.2%, and the pooled Lichtenstein reports(24) support an overall infection rate of 0.03% for patch repair. The incidence of post-operative wound infection in this study was comparable with that in a study performed by Aziz et al (3%)(26), Najamalhaq and colleagues (3%)(27), and relatively higher than the rate of infection reported by British Hernia Centre (1.2%)(28). The difference in rates of infection might be related to difference in minor breaks in antisepsis and aseptic procedure for the changing load of different operations done by the general surgeon when contrasted by the meticulous technique of a hernia specialist in British Hernia Centre in a closed theatre environment for hernia repair only. The infection did not lead to the removal of the mesh in this study and most other series(7,8) but it was a risk factor for hernia recurrences. Wound haematoma and seroma were often associated with the resultant wound infection but by themselves were not a significant factor. Chronic pain or persisting neuralgia has been recognized as a long-term complication and disability following inguinal herniorraphy causing notable effect on quality of life and daily activities(29-31). This is confirmed by the results of the present study, in which the incidence of chronic post-operative pain was significantly reduced from 12.4% in the suturedrepair group to 4% in the mesh-repair group, possibly due to association of tension that is usually produced by sutured repair, and is in accordance with the finding reported by Wantz et al, who firmly stated that chronic herniorrhaphy neuralgias are mostly the result of tension-producing technique. The repair, and not the entrapment of a nerve, is the cause of pain(32). In the present study, the majority of participants (72.6%) were under the age of 60 years, thus still active in their respective professions, and early return to work was of paramount importance to them. In patients who were manual workers and daily wage earners, the ambulation was the immediate concern. The tension-free technique did facilitate earlier ambulation and earlier return of patients to normal activities in this study. The difference was appreciable (a mean of 16days vs. 20days). This is comparable to other published trials(8,9). Conclusion Tension-free mesh repair is safe, effective and simple to perform. It has a lower recurrence rate, lesser postoperative pain, lesser consumption of analgesia, faster rehabilitation and greater patients> satisfaction with the operation than the sutured repair in the hands of general surgeons.

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