Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh
Page content transcription
If your browser does not render page correctly, please read the page content below
BJS, 2021, 108, 138–144 DOI: 10.1093/bjs/znaa049 Advance Access Publication Date: 28 December 2020 Randomized Clinical Trial Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh M. Rutegård1,2, M. Lindqvist1, J. Svensson1,3, P. Nordin4 and M. M. Haapamäki 1, * Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 1 Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden 2 Wallenberg Centre for Molecular Medicine, Umeå University, Umeå, Sweden 3 Department of Statistics, Umeå School of Business, Economics and Statistics, Umeå University, Umeå, Sweden 4 Department of Surgical and Perioperative Sciences, Surgery, Östersund Research Unit, Umeå University, Östersund, Sweden *Correspondence to: Department of Surgical and Perioperative Sciences, Surgery, Umeå University, SE-901 85 Umeå, Sweden (e-mail: email@example.com) Abstract Background: There is a shortage of high-quality studies regarding choice of mesh in open anterior inguinal hernia repair in relation to long-term chronic pain. The authors hypothesized that heavyweight compared with lightweight mesh causes increased postoper- ative pain. Methods: An RCT was undertaken between 2007 and 2009 at two sites in Sweden. Men aged 25 years or older with an inguinal hernia evaluated in the outpatient clinic were randomized in an unblinded fashion to heavyweight or lightweight mesh for open anterior in- guinal hernia repair. Data on pain affecting daily activities, as measured by the Short-Form Inguinal Pain Questionnaire 9–12 years af- ter surgery, were collected as the primary outcome. Differences between groups were evaluated by generalized odds and numbers needed to treat. Results: A total of 412 patients were randomized; 363 were analysed with 320 questionnaires sent out. A total of 271 questionnaires (84.7 per cent) were returned; of these, 121 and 150 patients were in the heavyweight and lightweight mesh groups respectively. Pain affecting daily activities was more pronounced in patients randomized to heavyweight versus lightweight mesh (generalized odds 1.33, 95 per cent c.i. 1.10 to 1.61). This translated into a number needed to treat of 7.06 (95 per cent c.i. 4.28 to 21.44). Two reoperations for recurrence were noted in the heavyweight mesh group, and one in the lightweight mesh group. Conclusion: A large-pore lightweight mesh causes significantly less pain affecting daily activities a decade after open anterior ingui- nal hernia repair. Registration number: NCT00451893 (http://www.clinicaltrials.gov). Introduction compared with heavyweight mesh at 6 months after inguinal hernia repair. However, results are conflicting, as other stud- Inguinal hernia is the most common type of hernia in men, with ies14,15 evaluating pain 3–5 years after surgery did not show such a lifetime risk of 27 per cent1. Therefore, with estimated 20 mil- differences. Unfortunately, there are very limited long-term data lion inguinal repairs performed each year2, each improvement in addressing this topic from RCTs. surgical technique translates into substantial public health bene- The purpose of this study was to evaluate the long-term im- fits. pact of heavyweight or lightweight mesh on chronic pain, dis- Mesh repairs have become standard practice for inguinal her- comfort, and recurrence rates a decade after open anterior nias3,4, as recurrence rates are lower than those associated with inguinal hernia repair. It was hypothesized that the lightweight classical tissue repair5. Because recurrence rates are now low, the mesh group would have less pain and discomfort than the heavy- focus of technical improvements has shifted to outcomes such as weight mesh group, whereas recurrence rates would be similar in chronic postoperative pain, which affects up to 30 per cent of all the two groups. patients after inguinal hernia repair6–8. Chronic postoperative pain is classified by the ICD-11 as pain lasting more than 3 months after surgery9. This pain is often neuropathic in charac- Methods ter, believed to be caused by tissue and nerve trauma induced by This was a follow-up study of a previous expertise-based, paral- surgical dissection, as well as inflammation and a foreign body lel-group RCT16, carried out at the regional centres Umeå reaction owing to the suture material and mesh10,11. University Hospital and Östersund Hospital, Sweden. In this Some studies12,13 have reported that the use of lightweight study, men aged at least 25 years with a symptomatic unilateral mesh is associated with decreased postoperative chronic pain inguinal hernia were randomized (1 : 1) to a group of surgeons Received: June 26, 2020. Revised: September 8, 2020. Accepted: September 20, 2020 C The Author(s) 2020. Published by Oxford University Press on behalf of BJS Society Ltd. V This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact firstname.lastname@example.org
Rutegård et al. | 139 that use either heavyweight (90 g/m2, BardTM Flatmesh; Davol) or Study measures lightweight (28 g/m2, ULTRAPROTM; Ethicon) mesh. The age crite- The exposure of the study was the type of mesh used for the pri- rion was chosen to ensure a fully grown patient and acceptance mary inguinal hernia repair, either heavyweight or lightweight. of local anaesthesia. Patient exclusion criteria were: femoral her- The main outcome was the occurrence of chronic pain 9–12 years nias, unwillingness to participate, refusal of local anaesthesia, after open anterior inguinal hernia repair with the standardized bleeding disorders, and concurrent use of anticoagulation ther- Lichtenstein technique. The primary outcome, the first item of apy. The study was expertise-based, meaning that surgeons used the sf-IPQ, comprises a seven-grade ordinal scale measuring the the type of mesh they personally preferred, minimizing the prob- impact of pain in the groin on different daily activities, whereas ability of differential expertise bias17. The two groups of surgeons’ the McCarthy visual analogue scale, which ranges from 0 to 150 surgical experience was evaluated. Surgical trainees were mm, measures the mean intensity of pain during the past week. allowed to participate provided they had reached surgical inde- Other secondary outcomes evaluated were patient-reported pendence for primary inguinal hernia repair, for which a mini- awareness of a groin lump (yes or no), perception of foreign mate- mum of 20 unsupervised inguinal hernia repairs was required. rial in the groin (yes or no), loss of skin sensation in the operated Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 The study group attested that the groups of surgeons for each in- groin (yes or no), other discomfort or pain located in the groin tervention arm were sufficiently similar in terms of surgical ex- (yes or no), and the patient’s impression of groin symptoms com- perience. Specification of surgeon groups can be found in Table pared with before surgery (better, no change or worse) as well as S1. Randomization was stratified by centre and performed at the overall satisfaction with the surgery (completely satisfied, mostly outpatient clinic, after consent for surgery had been obtained. satisfied, mostly unsatisfied or completely unsatisfied). The randomization did not include stratification for preoperative Reoperations for recurrences and patient-perceived recurrences pain, and blinding of patients and surgeons was not achieved. were also compared between mesh groups. The questionnaire The random allocation sequence was computer-generated by a consisted of a total of 10 questions covering the outcomes of the present study. statistician by means of a random number technique. Allocation was obtained for each patient from a central web-based server Statistical analysis (https://www.norrlandskirurgi.se). The program concealed the al- The analysis was performed using the intention-to-treat princi- location sequence. ple. As some of the variables had a skewed distribution, the A standardized manual for carrying out the operation was dis- results are reported as median (i.q.r.). Categorical variables are tributed and used by all participating surgeons. Additionally, sur- presented as frequencies with percentages, and were analysed geons had to undertake two operations under supervision before using Fisher’s exact test. The Mann–Whitney U test was used being accepted to participate in the study. This report of long- to evaluate differences between mesh groups in the ordinal sf- term results is written according to the CONSORT 2010 guide- IPQ and McCarthy pain scales. The primary outcome, sf-IPQ line18. grade, was also analysed using generalized Wilcoxon–Mann– All patients provided informed consent to participate in the Whitney odds (WMW odds)22,23, providing data on the odds of present study, which was conducted according to the latest revi- shifting from one response level to the next as a function of sion of Declaration of Helsinki and approved by the ethical review mesh allocation. This analysis was also used to derive num- board at Umeå University. bers needed to treat. A sensitivity analysis using ordinal re- gression was undertaken to evaluate the impact of adherence Study design bias and chance confounding, using the following co-variables: Of 412 patients randomized, 363 were analysed in the original age, BMI (less than 25, 25–30, or over 30 kg/m2), hernia type trial. These patients were cross-checked against the Swedish pop- (indirect, direct or combined), preoperative McCarthy pain ulation registry, using the national personal registration num- score (0 to 150) and ASA grade (I, II or III). All tests were two- ber19, 9–12 years after the inguinal hernia repair, to exclude those sided, and P < 0.050 was considered significant. For illustrative purposes, a box plot was used for the McCarthy pain scale dis- who had died. Information about the follow-up study and ques- tribution at follow-up. tionnaires were sent out to the remaining 320 patients, and a re- According to the power calculation for the original trial16, search nurse contacted all patients who could be reached by some 240 patients in total were needed to demonstrate a reduc- telephone and asked if they were willing to take part in the pre- tion in the proportion of patients reporting pain from 30 to 15 per sent follow-up study. The questionnaire consisted of the first cent, with 80 per cent statistical power. Before the questionnaires item of the Short-Form Inguinal Pain Questionnaire (sf-IPQ)20, the were sent out, it was assumed that this number of patients could McCarthy visual analogue scale21, and a set of study-specific be included and the present study was therefore considered feasi- questions. The data were inserted and matched into a Microsoft R ble. AccessV database (version 14; Microsoft, Redmond, Washington, R V Data analysis was done in Stata release 15 (StataCorp, USA) together with the baseline data from the previous study, College Station, Texas, USA) and R version 3.6.3 (R Foundation for and double-checked for errors. Linkage was also made to the na- Statistical Computing, Vienna, Austria). tional Swedish Hernia Register to obtain data on reoperations for recurrence or chronic pain. Baseline data collected for the previ- ous study included patient age, BMI, preoperative pain measured Results with the McCarthy pain scale during normal activity, patient- All operations were performed during 2007–2009 with open ante- reported preoperative regular pain medication, hernia type, ASA rior inguinal hernia repair according to Lichtenstein using local fitness grade, operated side, duration of operation, study centre, anaesthesia24. Some 320 of 363 patients from the earlier analysis and information on surgical experience of the two groups of sur- were alive by the end of March 2018. Of these, 271 (84.9 per cent) geons participating in the study. consented to participate and returned questionnaires: 121
140 | BJS, 2021, Vol. 108, No. 2 Assessed for eligibility n = 858 Enrolment Excluded n = 446 • Did not meet inclusion criteria n = 152 • Met exclusion criteria or declined to participate n = 294 Randomized n = 412 Allocation Heavyweight mesh group n = 206 Lightweight mesh group n = 206 • Operation n = 197 • Operation n = 194 • Declined surgery n = 9 • Declined surgery n = 12 Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 in previous study Follow-up Lost to follow-up n = 15 Lost to follow-up n = 4 • Operation in non-participating hospital n = 2 • Operation in non-participating hospital n = 0 • Declined follow-up n = 13 • Declined follow-up n = 4 in previous study Analysed n = 178 Analysed n = 185 Analysis Excluded from analysis n = 4 Excluded from analysis n = 5 • Erroneously included n = 4 • Erroneously included n = 4 • Operated by non-expert n = 0 • Operated by non-expert n = 1 Follow-up Lost to follow-up n = 57 Lost to follow-up n = 35 • Patient died n = 29 • Patient died n = 14 • Questionnaire not returned n = 28 • Questionnaire not returned n = 21 Analysis Analysed Analysed n = 121 n = 150 Fig. 1 CONSORT diagram showing patients included in long-term follow-up patients in the heavyweight mesh group and 150 in the light- mesh group included more patients on regular pain medication weight mesh group (Fig. 1). The questionnaire was answered be- before surgery (8.0 versus 4.1 per cent). Operating time was tween 19 April and 20 September 2018. There were more deaths slightly shorter in the heavyweight group, with a median of 68.5 during the postoperative follow-up in the heavyweight mesh (i.q.r. 60.0–80.0)) min, compared with 74.5 (61.5–90.0) min in the group than in the lightweight mesh group (29 of 178 versus 14 of lightweight group. 185; P ¼ 0.014). Baseline data collected in conjunction with the inclusion of Chronic pain patients in the original study are shown for the group participat- The impact of pain on daily activities was measured using the ing in this follow-up study in Table 1. Study groups were compara- seven-grade sf-IPQ scale, and a statistically significant differ- ble concerning age, BMI, hernia type, ASA grade, and McCarthy ence in favour of the lightweight mesh was evident (P ¼ 0.003) preoperative pain score during normal activity. The lightweight (Table 2). In the heavyweight group, the proportion of patients
Rutegård et al. | 141 Table 1 Baseline characteristics of 271 men who participated in the follow-up study a decade after surgery, stratified by type of mesh in open anterior inguinal hernia repair Heavyweight mesh (n ¼ 121) Lightweight mesh (n ¼ 150) Age (years)* 61.1 (52.9–66.4) 61.3 (53.7–67.4) BMI (kg/m2)* 25.5 (23.3–27.2) 25.1 (23.5–26.9) Preoperative McCarthy pain score*† 18 (5–43) 23 (5–50) Preoperative regular pain medication No 108 (89.3) 130 (86.7) Yes 5 (4.1) 12 (8.0) Not classified 8 (6.6) 8 (5.3) Hernia type Indirect 67 (55.4) 84 (56.0) Direct 45 (37.2) 48 (32.0) Combined 9 (7.4) 16 (10.7) Not classified 0 (0) 2 (1.3) Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 ASA fitness grade I 72 (59.5) 98 (65.3) II 43 (35.5) 47 (31.3) III 6 (5.0) 5 (3.3) Operated side Left 55 (45.5) 63 (42.0) Right 66 (54.5) 87 (58.0) Centre Umeå 57 (47.1) 68 (45.3) Östersund 64 (52.9) 82 (54.7) Duration of operation (min)* 68.5 (60.0–80.0) 74.5 (61.5–90.0) Values in parentheses are percentages unless indicated otherwise; *values are median (i.q.r.). Percentages may not add up owing to rounding. †Measured during normal activity. Table 2 Proportion of patients in pain categories of the first item of the Short-Form Inguinal Pain Questionnaire, 9–12 years after open anterior inguinal hernia repair sf-IPQ grade20 Description Heavyweight mesh (n ¼ 121) Lightweight mesh (n ¼ 150) 1 No pain 89 (73.6) 132 (88.0) 2 Pain present but can easily be ig- 18 (14.9) 8 (5.3) nored 3 Pain present, cannot be ignored, 7 (5.8) 5 (3.3) but does not interfere with daily activities 4 Pain present, cannot be ignored, 3 (2.5) 3 (2.0) interferes with concentration on chores and daily activities 5 Pain present, cannot be ignored, 1 (0.8) 1 (0.7) interferes with most activities 6 Pain present, cannot be ignored, 1 (0.8) 0 (0) necessitates bed rest 7 Pain present, cannot be ignored, 1 (0.8) 0 (0) prompt medical advice sought Missing response 1 (0.8) 1 (0.7) Values in parentheses are percentages. The first item of the Short-Form Inguinal Pain Questionnaire (sf-IPQ) measures the impact of pain in the groin on different daily activities, estimated as the worst pain felt in the operated groin during the past week. P ¼ 0.003 for global difference between mesh groups (Mann–Whitney U test). The sf-IPQ grade was used as a continuous numerical test value for each patient in the calculation. who were pain-free was 89 of 121 (73.6 per cent) compared to the next higher with use of heavyweight mesh. This trans- with 132 of 150 (88.0 per cent) in the lightweight group, lated to a number needed to treat of 7.06 (95 per cent c.i. 4.28 whereas easily ignored pain was reported by 18 of 121 (14.9 to 21.44). In the ordinal regression sensitivity analysis, the per cent) and 8 of 150 (5.3 per cent) respectively. The propor- results of unadjusted (odds ratio (OR) 2.63, 95 per cent c.i. 1.38 tion of patients with pain that could not be ignored but did to 5.02) and adjusted (OR 2.41, 1.18 to 4.90) analyses were sim- not interfere with activities was 7 of 121 (5.8 per cent) and 5 ilar. of 150 (3.3 per cent) in the heavyweight and lightweight groups The McCarthy postoperative pain scale values were slightly respectively. higher in the heavyweight mesh group (112 patients) with a me- With the lightweight group as the reference category, a gen- dian value of 4 (95 per cent c.i. 3 to 5), compared with 3 (3 to 4) in eralized WMW odds of 1.33 (95 per cent c.i. 1.10 to 1.61; the lightweight group (132 patients) (Fig. 2). However, this trend P ¼ 0.004) was derived for a shift from a lower sf-IPQ category did not reach statistical significance (P ¼ 0.099).
142 | BJS, 2021, Vol. 108, No. 2 Groin symptoms Some 83.0 per cent of all patients were completely satisfied with There was a statistically significant difference regarding the per- the surgery, 15.6 per cent were mostly satisfied, whereas 1.5 per ception of foreign material in the groin, favouring the lightweight cent were either mostly or completely unsatisfied. There was no mesh (P ¼ 0.006) (Table 3). There were no significant differences in statistically significant difference between the groups (Table 5). awareness of a groin lump, loss of sensation, or other pain and discomfort. Recurrence Some 95.1 per cent of all patients rated their groin symptoms Rates of patient-reported recurrence in the heavyweight and as better than before surgery, 4.5 per cent deemed that their lightweight groups were 5.8 per cent (7 of 121) and 2.1 per cent symptoms were the same as before, whereas 0.4 per cent reck- (3 of 145) respectively. This difference was not statistically signifi- oned that the symptoms were worse. No significant differences cant (P ¼ 0.193). According to the Swedish Hernia Register, reoper- could be discerned between the study groups (Table 4). ation was undertaken for only three recurrences in the cohort of 271 patients, two in the heavyweight group and one in the light- weight group; the latter was operated on using a polytetrafluoro- 150 ethylene mesh that was not intended for the study, which Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 constituted a protocol violation. Discussion In this long-term follow-up of an RCT comparing the use of heavyweight and lightweight mesh in open anterior inguinal her- nia repair in adult men, there was a difference in pain affecting daily activities as well as in the perception of foreign material 9– 12 years after surgery, favouring the lightweight mesh; this trans- 100 lated into a number needed to treat of 7.06 regarding chronic pain. However, there were no statistically significant differences VAS score (mm) between mesh groups in other groin symptoms, pain measured by the McCarthy pain scale, satisfaction or symptoms after oper- ation compared with before surgery. Regardless of mesh type used, the great majority of patients experienced significant im- provement in symptoms and satisfaction with the inguinal her- nia repair. Only three patents underwent reoperation for hernia recurrence in the decade after inguinal hernia repair. 50 The strengths of this study include that it was an expertise- based RCT, minimizing the possibility of selection bias as well as bias related to surgeon experience. The operating techniques were standardized and the surgical performance was controlled at the start of the study. There was also an excellent response rate, with 84.7 per cent of patients returning questionnaires. Table 4 Assessment of symptoms 9–12 years after surgery, compared with situation perceived before surgery, stratified by type of mesh 0 HWT LWT Heavyweight mesh (n ¼ 121) Lightweight mesh (n ¼ 150) Fig. 2 Pain assessed with the McCarthy visual analogue scale according Worse 1 of 121 (0.8; 0.2, 4.5) 0 of 147 (0; 0, 2.0) to type of mesh No change 6 of 121 (5.0; 1.8, 10.5) 6 of 147 (4.1; 1.5, 8.7) Pain was measured on a visual analogue scale (VAS) from 0 to 150 mm. Bold Better 114 of 121 (94.2; 88.4, 97.6) 141 of 147 (95.9; 91.3, 98.5) horizontal lines represent median value, boxes indicate i.q.r., and whiskers indicate the adjacent values which are the highest value not greater than the Values in parentheses are percentages, with 95 per cent Chopper–Pearson 75th percentile þ1.5 i.q.r.. Outliers are marked with a dot. HWT, heavyweight confidence interval. Data were missing for some patients. P ¼ 0.125 for global mesh group; LWT, lightweight mesh group. difference between mesh groups (Fisher’s exact test). Table 3 Global assessment of groin symptoms 9–12 years after surgery, stratified by type of mesh Heavyweight mesh (n ¼ 121) Lightweight mesh (n ¼ 150) P* Perception of foreign material in 16 of 104 (15.4) 6 of 134 (4.5) 0.006 groin Awareness of a groin lump 9 of 106 (8.5) 7 of 141 (5.0) 0.303 Loss of skin sensation in groin 18 of 105 (17.1) 21 of 138 (15.2) 0.726 Discomfort in groin 16 of 101 (15.8) 16 of 140 (11.4) 0.341 Patient-perceived recurrence 7 of 121 (5.8) 3 of 145 (2.1) 0.193 Values in parentheses are percentages. Data were missing for some patients. *Fisher’s exact test.
Rutegård et al. | 143 Table 5 Assessment of patient satisfaction 9–12 years after surgery, stratified by type of mesh Heavyweight mesh (n ¼ 121) Lightweight mesh (n ¼ 150) Completely unsatisfied 2 of 121 (1.7; 0.2, 5.8) 0 of 149 (0; 0, 2.0) Mostly unsatisfied 1 of 121 (0.8; 0, 4.5) 1 of 149 (0.7; 0, 3.7) Mostly satisfied 23 of 121 (19.0; 12.9, 27.0) 19 of 149 (12.8; 7.8, 19.2) Completely satisfied 95 of 121 (78.5; 70.1, 85.5) 129 of 149 (86.6; 80.0, 91.6) Values in parentheses are percentages with 95 per cent Chopper–Pearson confidence interval. Data were missing for one patient. P ¼ 0.653 for global difference between mesh groups (Fisher’s exact test). Moreover, validated questionnaires were used along with modern The sf-IPQ analysis provided evidence favouring the light- statistical modelling, and sensitivity analyses were used to cor- weight mesh in this trial, but this was not corroborated using the Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 roborate the trial findings. McCarthy pain scale. Both variables measure pain, although in a Although missing values were frequent in the study, every different manner. One can speculate that the discordance might questionnaire item reached an response percentage exceeding 83 be explained by the seeming difficulty patients had in responding per cent. The variables with the highest degree of completeness to the McCarthy pain scale item, as the response rate was lower were the first item of the sf-IPQ scale, as well as the questions on (99.3 versus 90.0 per cent) and some patients seemed to answer satisfaction and comparisons before and after surgery, all with the question incorrectly. The authors suspect a common error at rates rounding up to at least 99 per cent. The questions are sim- the lower end of the McCarthy scale, which indicates the absence ple and easy to understand, whereas more complicated questions of pain. Some patients seemed to have interpreted the location might lead to omission of the question completely. immediately above the centre of the sentence ‘no pain sensation’ This study was carried out on men with a primary inguinal to indicate the absence of pain. This gives a measure of 5–10 mm hernia. Therefore, no general conclusion can be made for other on the pain scale instead of the presumed 0 mm, whereas most types of inguinal hernia and other patient groups, such as chil- patients were in fact pain-free. This is a likely source of non- dren and women. However, the authors believe the hypothesis differential misclassification in the McCarthy pain scale variable, that less foreign material in the wound causes less inflammation, probably causing bias towards the null. It is also of note that no and hence less chronic pain, should apply to most circumstances differences between groups could be ascertained in the second- in which mesh is used for hernia repair. There is, however, a ca- ary comparison of groin symptoms before and after surgery; al- veat regarding the relationship between pore size and mesh though this could be interpreted as contradicting the main result, weight that necessitates comment; this trial was conducted in an the finding might be explained by the fact that this question was era when heavier meshes also signified a smaller pore size, which not validated formally and gives no measure of how much better is not always true with modern mesh types. Therefore, caution the situation became after surgery, and also that a considerable must be taken to not extrapolate the study findings to all types of time span had passed since the inguinal hernia repair. The current trend in inguinal surgery in Sweden is the increas- heavyweight mesh. ing use of lightweight meshes28, which is also recommended by In the original trial with short-term results16, there were sta- the European Hernia Society guidelines29. The present findings tistically significant differences regarding awareness of a groin further support this recommendation, when considering the lump and discomfort in the groin 12 months after surgery. A de- long-term reductions in chronic pain. cade after surgery the differences in these specific symptoms had levelled out and were no longer significant. There was no statisti- cally significant difference in the rate of reoperation for hernia re- Acknowledgements currence, although a few more patients in the heavyweight group The authors thank research nurse A. Karhu and secretary L. reported subjective experiences of recurrence (5.8 versus 2.1 per Häggkvist for assisting with data collection. This study was cent); yet only two patients in this group underwent reoperation funded by Västerbotten County Council, the VISARE NORR Fund, for recurrence. The high rate of subjective recurrences might be and the Knut and Alice Wallenberg Foundation. explained by the increased rates of foreign material and groin lump awareness; they did not represent true recurrences. Disclosure. The authors declare no conflict of interest. Nevertheless, the present results are in line with those of previ- ous studies25,26 suggesting that lightweight meshes are as good as heavyweight meshes in preventing recurrence after open ante- Supplementary material rior mesh inguinal hernia repair, provided that an appropriate Supplementary material is available at BJS online. surgical technique is employed. A recent well conducted trial27 of laparoscopic totally extraperitoneal repairs showed that a heavy- weight mesh was superior to a lightweight mesh, both in terms of References chronic pain and recurrence rates. Of importance, the trial allo- 1. Dabbas N, Adams K, Pearson K, Royle G. Frequency of abdomi- cation was blinded to both patient and investigator, minimizing a nal wall hernias: is classical teaching out of date? JRSM Short Rep bias that might have influenced the results of the present trial. 2011;2:5 However, the laparoscopic extraperitoneal technique differs sig- 2. Kingsnorth A, LeBlanc K.Hernias: inguinal and incisional. The nificantly from the open technique, particularly concerning Lancet 2003;362:1561–1571 mesh placement and fixation, questioning its comparability with 3. Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, studies using an open approach. Campanelli G, Conze J et al. European Hernia Society guidelines
144 | BJS, 2021, Vol. 108, No. 2 on the treatment of inguinal hernia in adult patients. Hernia 18. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, 2009;13:343–403 Devereaux PJ et al. CONSORT 2010 explanation and elaboration: 4. HerniaSurge Group. International guidelines for groin hernia updated guidelines for reporting parallel group randomised tri- management. Hernia 2018;22:1–165 als. Int J Surg 2012;10:28–55 5. EU Hernia Trialists Collaboration. Repair of groin hernia with 19. Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. synthetic mesh: meta-analysis of randomized controlled trials. The Swedish personal identity number: possibilities and pitfalls Ann Surg 2002;235:322–332 in healthcare and medical research. Eur J Epidemiol 2009;24: 6. Callesen T, Bech K, Kehlet H. Prospective study of chronic pain 659–667 after groin hernia repair. Br J Surg 1999;86:1528–1531 20. Olsson A, Sandblom G, Franneby U, Sonden A, Gunnarsson U, 7. Bay-Nielsen M, Perkins FM, Kehlet H. Pain and functional im- Dahlstrand U. The Short-Form Inguinal Pain Questionnaire pairment 1 year after inguinal herniorrhaphy: a nationwide (sf-IPQ): an instrument for rating groin pain after inguinal her- questionnaire study. Ann Surg 2001;233:1–7 nia surgery in daily clinical practice. World J Surg 2019;43: 8. Poobalan AS, Bruce J, King PM, Chambers WA, Krukowski ZH, 806–811 Smith WC. Chronic pain and quality of life following open ingui- 21. McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price Downloaded from https://academic.oup.com/bjs/article/108/2/138/6053676 by guest on 16 September 2021 nal hernia repair. Br J Surg 2001;88:1122–1126 DD, Jonasson O et al. Visual analog scales for assessing surgical 9. Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R et al. pain. J Am Coll Surg 2005;201:245–252 A classification of chronic pain for ICD-11. Pain 2015;156: 22. Churilov L, Arnup S, Johns H, Leung T, Roberts S, Campbell BC 1003–1007 et al. An improved method for simple, assumption-free ordinal 10. Aide N, Deux JF, Peretti I, Mabille L, Mandet J, Callard P et al. analysis of the modified Rankin scale using generalized odds ra- Persistent foreign body reaction around inguinal mesh prosthe- tios. Int J Stroke 2014;9:999–1005 ses: a potential pitfall of FDG PET. AJR Am J Roentgenol 2005;184: 23. O’Brien R, Castelloe J. Exploiting the Link Between the Wilcoxon– 1172–1177 Mann–Whitney Test and a Simple Odds Statistic. https://support. 11. Hakeem A, Shanmugam V. Inguinodynia following Lichtenstein sas.com/resources/papers/proceedings/proceedings/sugi31/ tension-free hernia repair: a review. World J Gastroenterol 2011; 209-31.pdf (accessed 11 December 2020) 17:1791–1796 24. Amid PK, Shulman AG, Lichtenstein IL. Open ‘tension-free"’ re- 12. Sajid MS, Leaver C, Baig MK, Sains P. Systematic review and pair of inguinal hernias: the Lichtenstein technique. Eur J Surg meta-analysis of the use of lightweight versus heavyweight 1996;162:447–453 mesh in open inguinal hernia repair. Br J Surg 2012;99:29–37 25. Demetrashvili Z, Khutsishvili K, Pipia I, Kenchadze G, Ekaladze 13. Uzzaman MM, Ratnasingham K, Ashraf N. Meta-analysis of ran- E. Standard polypropylene mesh vs lightweight mesh for domized controlled trials comparing lightweight and heavy- Lichtenstein repair of primary inguinal hernia: a randomized weight mesh for Lichtenstein inguinal hernia repair. Hernia controlled trial. Int J Surg 2014;12:1380–1384 2012;16:505–518 26. Smietanski M, Smietanska IA, Modrzejewski A, Simons MP, 14. Bury K, Smietanski M; Polish Hernia Study Group. Five-year results of a randomized clinical trial comparing a polypropylene Aufenacker TJ. Systematic review and meta-analysis on heavy mesh with a poliglecaprone and polypropylene composite mesh and lightweight polypropylene mesh in Lichtenstein inguinal for inguinal hernioplasty. Hernia 2012;16:549–553 hernioplasty. Hernia 2012;16:519–528 15. Nikkolo C, Vaasna T, Murruste M, Seepter H, Kirsimagi U, 27. Roos MM, Bakker WJ, Schouten N, Voorbrood CEH, Clevers GJ, Lepner U. Randomized clinical study evaluating the impact of Verleisdonk EJ et al. Higher recurrence rate after endoscopic to- mesh pore size on chronic pain after Lichtenstein hernioplasty. tally extraperitoneal (TEP) inguinal hernia repair with ultrapro J Surg Res 2014;191:311–317 lightweight mesh: 5-year results of a randomized controlled 16. Rutegard M, Gumuscu R, Stylianidis G, Nordin P, Nilsson E, trial (TULP-trial). Ann Surg 2018;268:241–246 Haapamaki MM. Chronic pain, discomfort, quality of life and 28. Nilsson H, Nordin P, Holmberg H, Öberg M. Registret för ljumsk- impact on sex life after open inguinal hernia mesh repair: an bråcks-operationer, Nationell Rapport, 2018. http://www.svenskt expertise-based randomized clinical trial comparing lightweight brackregister.se/rapporter-71/verksamhetsberaettelser and heavyweight mesh. Hernia 2018;22:411–418 (accessed 11 December 2020) 17. Walter SD, Ismaila AS, Devereaux PJ; SPRINT Study 29. Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Investigators. Statistical issues in the design and analysis of Conze J, et al. Update with level 1 studies of the European Hernia expertise-based randomized clinical trials. Stat Med 2008;27: Society guidelines on the treatment of inguinal hernia in adult 6583–6596 patients. Hernia 2014;18:151–163
You can also read