Hernia (2000) 4:311-315

Hernia 9 Springer-Verlag 2000

A prospective evaluation of the PerFix| Plug technique for groin hernia repair

J.M. Zdolsek, J. Enebog, C. Wallon, and A. Kald Department of Surgery, University Hospital, S-581 85 Link6ping, Sweden

Summary: The aim of the study was to prospectively evaluate complication rates, sick-leave, recurrence rate, and chronic post-operative pain after meshplug hernia repair. All 385 consecutive inguinal hernias (373 patients) operated at our department with the PerFix | Plug from September 1996 to December 1997 were included in the study. Follow-up included a questionnaire 3 and 12 months after the repair. Replies to the both of these questionnaires J were obtained from 363 of 373 patients (98%). All patients who either reported a lump or sensory disturbance in the operated groin were offered a clinical examination. A third questionnaire focusing on chronic post-operative pain was completed by 77 ofgo patients reporting groin pain. The recurrence rate was 2% (9/385). After 25 months (17-36 months) 38 patients (lO%) still experienced inguinal pain to some degree. In 7 male patients there was either pain or discomfort during sexual activities. In a patient with poorly controlled ascites the plug was removed. Day-case surgery was performed in 86% of patients with epidural or local anaesthesia, and 64% in general- or spinal anaesthesia. Employed/self-employed patients were off work for a median of 7 days (o-65). The median time to full recovery for all patients was 2o days. i Conclusion: Mesh-plug hernia repair has a reasonably low complication rate together with quick recovery in a non-specialised surgical setting. Chronic inguinal pain is, however, still present to some degree in lO% of patients after two y e a r s

Correspondence to: J.M. Zdolsek

e-mail: [email protected]

Key words: Inginal hernia - Surgical mesh - Postoperative complications Recurrence - Pain Received June 2o, 2000 Accepted in final forrn October24, 2o00

It is generally agreed upon that excellent results can be obtained when using mesh reinforcement in hernia repair. This can either be achieved laparoscopically [Kald 1997] or by the use of a "tension-free" procedure such as the Lich-

tenstein technique [Amid 1996] or the mesh plug technique [Robbins 1998 ]. M1 of these methods have documented low recurrence rates, low complication rates, short periods of sick leave and rapid resumption of daily activities. Mesh plug

hernia repair was in our department chosen to be the method of choice for all types of hernia repair. The main reason for this being the need of a simple and efficacious method all surgeons could perform without extensive training,

312

which was considered the case with laparoscopic hernia repair. With the decrease of recurrence as a major clinical problem, chronic pain after inguinal hernia repair, which is a well-known but not extensively studied complication, is increasingly coming into focus. Chronic pain after hernia surgery is not infrequent and has been reported with up to 19% after 1 year [Cunningham 1996, Callesen 1999, Gillion 1999]. In a retrospective s t u d y by Palot and c o - w o r k e r s [1998], 7 o f 111 p a t i e n t s (6%) o p e r a t e d

with the PerFix-plug suffered from chronic severe to m o d e r a t e g r o i n pain 6 months after surgery which lead to removal of the plug in 2 cases. The aim of our study was to prospectively study the results of groin hernia surgery using the PerFix-plug technique with some focus on chronic pain in a Swedish general surgical department with participation of most staff surgeons and surgeons in training rather than specialised "hernia-teams".

Patients and methods In September 1996 mesh plug hernia repair using the PerFix| plug and patch as described in detail by Robbins and Rutkow [1998] was introduced at our department. The 385 first consecutive operations using the original method were included in the study, which was closed in December 1997. Five operations were excluded either due to use of a larger onlay mesh or due to use of a larger hand-made plug. Minor alterations of the technique, such as suturing the onlay patch to the pubic tubercle was accepted. Both resorbable and non-resorbable suture material was used. There were 373 p a t i e n t s (352 male and 21 female patients). 12 patients had bilateral operations. The m e d i a n age was 59 years (range 15-96 yrs.). The types of hernia are shown in Table 1. 19 surgeons performed the operations and at the time of the study, 11 were specialists and 8 under training. The specialist surgeons performed 128 (33%) hernia repairs and the surgeons under training 257 (67%) operations. The median number of operations was

J.M. Zdolsek, et al.: A prospective evaluation of mesh plug hernia repair Table 1. Types of hernia Characteristics

Number of patients Bilateral Indirect Direct Combined Femoral Unknown type Number of hernias

Primary hernias

Recurrent hernias

342 12 229 92 27 5 2 355

30 o 9 17 2 2 o 30

12 per surgeon (range 1-86). Epidural-, spinal-, local-, or general anaesthesia was used. At discharge from the hospital each patient was given a questionnaire with a prepaid envelope with questions concerning type of occupation, sick leave and time to full recovery. The patients were asked to return the questionnaire within three months. The patients were not b o o k e d for a f o l l o w - u p at the outpatient clinic but were instead encouraged to contact us and not their general practitioner in case of any postoperative problem. Patients were instructed to resume daily activities as soon as they felt this possible. They were however advised to avoid lifting heavier items than 15 kg during the first fortnight. In May 1998 a second questionnaire with two questions was sent to all patient, the first asking if there had been a recurrence of a lump in the operated groin and the second if there were any sensory disturbances such as pain in the operated groin. Those patients who by this time had not returned the first questionnaire were sent a copy also of this one. Those who did not return the second (or first) questionnaire were contacted by phone and completed the questionnaires in that way. Replies were finally obtained from 97% (n = 363/373) of the patients, In Fig. 1 the follow-up algorithm is shown. All patients reporting either a lump or discomfort of some kind in the operated groin were offered a clinical examination and patients belonging to the latter group were asked to complete a third questionnaire. This questionnaire focused on sensory disturbances and pain. Of the 85 patients reporting inguinal sensory disturbance pain 77 were rea-

ched and completed the third questionnaire. A few of these were completed by phone if the patients regarded themselves as c o m p l e t e l y s y m p t o m - f r e e . During the time period after questionnaire no. 2, 13 patients contacted the out-patient clinic due to some or other discomfort in the operated groin. Also these 13 patients were offered a clinical examination and completed questionnaire no. 3.

Results Median o p e r a t i n g time was 60 min (range 25-175 ) . The lO specialists performed 128 operations with a median operating time of 50 min, whereas the 7 surgeons in training performed 257 operations with a median operating time of 6o min. There were no peroperative complications with the definition of peroperetire complication being: extensive bleeding, vessel injury requiring vascular surgery, and bladder- or bowel inju-

ry. Day-case surgery was possible in 86% of the patients receiving either local- or epidural anaesthesia, with general- or spinal anaesthesia 64% of the patients could return home on the day of operation (Table 2). There was no difference in age between the groups receiving different forms of anaesthesia. The choice of anaesthesia rather being dependent on a combination of surgeons' -, a n a e s t h e s i o l o g i s t s ' - and patients' preference. There were 35 (9%) early postoperative complications (within 3o days) as shown in Table 3. In one patient the plug was removed. This patient had suffered from his second recurrence. In addition he had poorly controlled ascites due to

J.M. Zdolsek, et al.: A prospective evaluation of m e s h plug hernia repair

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Operation (n = 372)

Replies to questionaires 1 and 2 (n = 363)

Drop-outs (n = 9)

/

/

Reply to questionnaire 3 and examination due to inguinal discomfort (n = 90)

Drop-outs (n =8) I

t

Persisting pain or discomfort to some degree (n = 38)

Physical examination due to lump (n = 11)

No longer discomfort (n = 52)

Fig. 1

Follow-up procedure Table 2. Duration of hospital stay in relation to type of anaesthesia Hospital stay (days)

o

1

2

3

> 3

Epidurai (%), n = 115 Local (%), n = lo4 Spinal (%), n = 78 General (%), n = 76 Total (%), n = 373

86 85 64 63 76

11 lO 28 25 17

2 6 3 5 4

1 o 3 1 1

o o 3 5 2

T a b l e 3. Early p o s t o p e r a t i v e c o m p l i c a t i o n s (< 30 days) Complication

liver cirrhosis. In the postoperative phase there was leakage of ascites fluid and he was subsequently successfully reoperated without utilisation of mesh. Time off work and time to full recovery in relation to type of occupation is shown in Table 4. In the second questionnaire, median follow-up of 13 months (6-32 months), 85 patients (23% of the 363 answers) reported some kind of sensory disturbance in the operated groin. By this time 4 recurrent hernias were already known to us through patients contacting the outpatient clinic for examination. In the questionnaire u patients reported inguinal bulges. Of these bulges, 5 were recurrences and 6 palpable plugs or an elongated subcutaneous induration corresponding to the onlay mesh. The definition of recurrence was: the presence of a palpable bulge in the operation area and/or the presence of an expansile cough impulse [Kald 1998]. Thus at follow-up either via q u e s t i o n n a i r e or patients contacting us, 9 (2.3%) recurrences were found. Of these recurrences 4 were in patients with direct hernias, 3 with indirect and 2 with recurrent hernias (Table 5). Two specialist surgeons accounted for 3 and 2, respectively, of these recurrences and one resident for 4. At the two-year follow-up (median 25 months, range 13-36 months) 52 of the 9o patients had recovered fully and were symptom-free. The remaining 38 patients had inguinal symptoms of varying intensity and duration. Three patients have been referred to our painclinic for evaluation and treatment due to pain considered neuropathic in origin. Thus two years after the plug herniorraphy lO% of the patients still had inguinal pain to some degree, although

Number

(%) Table 4. Time o f f w o r k and time to full recovery in relation to occupation Haematoma Pain Seroma Superficial infection Hydrocele Hemorrhage Urinary retention Postspinal headache Ascites leak Total n u m b e r of early complications

11 (2.9) 8 (2.1) 5 (1.3) 5 (1.3) 2 (o.5) 1 (0.3) 1 (0.3) 1 (o.3) 1 (o.3) 35 (9.1)

Occupation Employed/self empl. (n = 193) 9 Manual work > 50 kg 9 Manual work lo-5o kg 9 Office work Retired (n = z57) Student/unemployed (n = 15)

Days off work (median; range)

Days tofull recovery (median; range)

7 (o-65) 13 (6-52) 8 (0-65) 5 (0-25)

20 (0-270) 3o (7-270) 20 (o-15o) 16 (1-12o) 17 (o-120) 14 (0-90)

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J.M. Zdolsek, etal.: A prospective evaluation of mesh plug hernia repair

Table 5. Characteristics of recurrences Type Direct Indirect

~

Primary

Recurrent

4 3

1

1

the m a j o r i t y to a mild degree. Only 5 patients ( 1 . 3 % ) felt that their groin pain was unchanged or worse after surgery than before (Table 6).

Table 6. Characteristics of chronic postoperative pain. Results of questionnaire no. 3 (median 25 months after operation) of patients who one year earlier or more recently had pain or groin discomfort I.

II.

II1.

Discussion As previously described, hernia repair using the PerFix| plug and patch has low rates of postoperative complications and recurrence [Robbins 1998, Bringman 20oo]. We were neither able to repeat the exceptionally low complication rates, nor able to perform all of the surgery on an ambulatory basis as has been described from a specialised centre [Robbins 1998]. Our data on early postoperative complications are similar to those of Palot and co-workers [1998] and also to those of another Swedish study by Bringman and co-workers [2000]. In the case of ambulatory surgery our results are also similar to the 87% reported by Bringman [2ooo] but differ significantly f r o m the 14% of Palot [1998]. It is, however, reasonable to assume that the differences in percentage ambulatory surgery do not have so m u c h to do with the m e t h o d p e r se rather than local tradition and acceptance among patients. This acceptance also includes the acceptance of patients of local anaesthesia instead of other types of anaesthesia. The markedly higher p r o p o r t i o n o f d a y - c a s e s u r g e r y in patients receiving either epidural- or local anaesthesia compared to spinal- or general anaesthesia is striking but not surprising and has in our department led to extensive use of local anaesthesia with even higher percentages of daycase surgery as result. The median time to r e t u r n to work was 7 days in our study which is slightly shorter than in the other Swedish study [Bringman 2ooo]. K i n g s n o r t h and c o - w o r k e r s [2ooo] have, on the other hand, reported longer time for r e t u r n to work with

IV.

V.

VI.

Frequency of pain in the operated groin (n = 9o) a) Not any more b) Constantly c) Every day d) Every week e) Every month Duration of pain (n = 38) a) A few seconds b) A few minutes c) A fewhours d) A day e) A week Circumstances leading to pain (n = 38) a) Rest b) Anytime, unpredictable c) With heavy lifting/strenuous exercise d) With certain movements Change of pain intensity with time (n = 38) a) Worse b) Unchanged c) Somewhat improved d) Vastly improved Impairment of daily living by pain and evaluation of its acceptability (n = 38) a) No impairment and fully acceptable b) Some impairment but still fully acceptable c) Impairment and unacceptable Present pain/status compared to before the operation (n = 90) a) Worse b) Unchanged c) Somewhat improved d) Vastly improved

15.2 days. Time to return to work is, however, not entirely dependent on the surgical method and has among other factors shown to be influenced by national social insurance policies [SalcedoWasicek 1995] which might account for part of the observed differences. When the plug and patch method was introduced at our department no particular training p r o g r a m m e was devised. It was recommended that surgeons unfamiliar with the technique assisted a colleague at some operations and/or viewed a video describing the method. Most operations were performed with a scrub nurse or a medical student as assistant. In view of this, the "robustness" of the m e t h o d must be appreciated when analysing recurrences and postoperative problems. The single surgeon approach and high proportion of operations performed by surgeons in training as well as inclusion of the learning curves of 17 surgeons may account for the relatively generous operating

52 z 3 26 8 lo lo 11 5 2 o zo z7 11 2 19 lo 7 29 6 3 5 4 4 77

times which are considerably longer than those described by Robbins and Rutkow [1998] or Kingsnorth and coworkers [2000]. We could draw no particular conclusions regarding the three surgeons who accounted for all of the recurrences, rather than the general reflection that although the method is quick and straightforward the simplicity must not be overestimated. Chronic groin pain in the postherniorraphy patient is a well known complication with an incidence of o-19% [Callesen 1999, Cunningham 1996, Palot 1998, Gillion 1999]. Our results are in accordance with other methods of hernia repair, in the longer term the pain seems to recede. After a median of two years lO.2% of our patients complained of c h r o n i c pain a l t h o u g h most of the patients only had mild symptoms. The vast majority of the patients considered their pain situation better or at least unchanged when comparing with their situation before the hernia surgery. Only

I.M. Zdolsek, et al.: A prospective evaluation of mesh plug hernia repair

five patients (1.3%) had more pain after than before the operation. These patients described that they had been more or less without pain before the operation. No patients have required a reexploration or removal of the plug due to chronic pain. This is in contrast to the results by Palot and co-workers [1998] where 2% of the plugs had to be removed due to pain within 6 months of the operation. The removal of as many as 4 of 71 PerFix| plugs (6%) due to chronic pain after one year has recently been reported in an English study [Kingsnorth 2ooo]. Mainly in younger men (median age 31 yrs.) were there complaints of inguinal postherniorraphy pain during sexual activity. The pain was either of a continuous character during erection and coitus (n = 5)

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or of a more suddenly appearing type during ejaculation (n = 2). These types of complaints have also previously been described [Cunningham 1996, Gillion 1999], the underlying mechanisms are not yet entirely clear. In an experimental study in dogs, Uzzo and co-workers [1999] have found marked foreign body reactions in the soft tissues surrounding the vas in spermatic chords exposed to Marlex. A common factor in this latter group of patients, who apart from being relatively young, also were slender with small amounts of subcutaneous fat. It may thus be a lack of "fat-padding" which leads to involvment of the spermatic cord in the postoperative fibrosis around the mesh. During the inclusion of patients to the study trimming of the

inner petals of the plug was very uncommon which may have led to more extensive fibrosis than necessary. In conclusion we consider that mesh plug hernia repair is a good and simple method for repair of all groin hernias. The early (< 3o days) postoperative complication rates and recurrence rates are low. Also return to work and time to full recovery is short in most patients. Chronic pain in our s t u d y though, seems to be of the same magnitude or at least not lower than in other methods of hernia repair. It is thus quite clear that a better understanding of the mechanisms behind post.-herniorraphy pain and ways of preventing the condition must be gained by the surgical community.

toneal approach in laparoscopic hernia repair: results of 491 consecutive herniorraphies. Surg Laparosc Endosc 7:86-89 Kald A, Nilsson E, Anderberg B, Bragmark M, Engstr6m P, Gunnarsson U, Haapaniemi S, Lindhagen J, Nilsson P, Sandblom G, Stubber6d A (1998) Reoperation as a surrogate endpoint in hernia surgery: A three year follow-up of 1565 herniorraphies. Eur J Surg 164:45-50 Kingsnorth A, Hyland M, Porter C, Sodergren S (200o) PerFix | Plug-and-Patch versus Lichtenstein Patch in inguinal hernia: Prospective Randomized Double-Blind Study of Medium-Term Outcome (Abstract). In AHSEHS joint Meeting, lune 15-18, 2000, Toronto, Canada Kingsnorth AN, Porter CS, Bennett DH, Walker AJ, Hyland ME, Sodergren S (zooo) Lichtenstein patch or Perfix plug-and-patch in

inguinal hernia: a prospective double-blind randomized controlled trial of short-term outcome. Surgery 127:276-283 Palot Jp, Avisse C, Cailliez-Tomasi JP, Greffier D, Flament JB (1998) The mesh plug repair of groin hernias: a three year experience. Hernia 2:31-34 Robbins AW, Rutkow IM (1998) Mesh plug repair and groin hernia surgery. Surg Clin North Am 78:loo7-1o23 Salcedo-Wasicek MC, Thirlby RC (1995) Postoperative course after inguinal herniorraphy. Arch. Surg. 13o: ~9-32 Uzzo RG, Lemack GE, Morrissey KP, Goldstein M (1999) The effects of bioprosthesis on the spermatic cord structures: a preliminary report in a canine model. J Urol 16i: 13441349

I References Amid PK, Schulman AG, Lichtenstein IL (1996) Open "tension-free" repair of inguinal hernias: the Lichtenstein technique. Eur J Surg 162:447-453 Bringman S, Ramel S, Nyberg B, Anderberg B (2000) Introduction of herniorraphy with mesh plug and patch. Eur J Surg 166:31o-312 Cunningham J, Temple WJ, Mitchell P, Nixon JA, Preshaw RM, Hagen NA (1996) Cooperative hernia study. Pain in the postrepair patient. Ann Surg 224. 598-602 Callesen T, Bech K, Kehlet (1999) Prospective study of chronic pain after groin hernia repair. Br J Surg 86:1528-1531 Gillion JF, Fagniez PL (1999) Chronic pain and cutaneous sensory changes after inguinal hernia repair: comparison between open and laparoscopic techniques. Hernia 3:75-80 Kald A, Anderberg B, Smedh K, Karlsson M (1997) Transperitoneal or totally extraperi-