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Open tension-free Lichtenstein repair of inguinal hernia:use of fibrin glue versus sutures for mesh fixation P. Negro • F. Basile • A. Brescia • G. M. Buonanno • G. Campanelli • S. Canonico •M. Cavalli • G. Corrado • G. Coscarella • N. Di Lorenzo • E. Falletto • L. Fei •M. Francucci • C. Fronticelli Baldelli • A. L. Gaspari • E. Gianetta • A. Marvaso •P. Palumbo • N. Pellegrino • R. Piazzai • P. F. Salvi • C. Stabilini • G. Zanghı` Received: 4 December 2009 / Accepted: 11 July 2010 / Published online: 30 July 2010Ó Springer-Verlag 2010 intensity was assessed by a visual analog scale (VAS; 0 [no To investigate pain and other complications following inguinal hernioplasty performed by the Lich- One hundred and seventy-one patients received tenstein technique with mesh fixation by fibrin glue or sutures and 349 received fibrin glue. During the early postoperative phase, 87.4% of patients in the fibrin glue Five hundred and twenty patients were enrolled group and 76.6% of patients in the sutures group were in this 12-month observational multicenter study and complication-free (P = 0.001). Patients who received received either sutures or fibrin glue (TissucolÒ/TisseelÒ) fibrin glue were also less likely to experience hematoma/ based on the preference of the surgeon. Pain, numbness, discomfort, recurrence, and other complications were P = 0.001). The mean pain score was significantly lower assessed postoperatively and at 1, 3, 6, and 12 months. Pain in the fibrin group than the sutures group (2.5 vs. 3.2, Azienda Ospedaliera Universita` degli Studi di Roma Azienda Ospedaliera, Universitaria San Giovanni Battista, Azienda Ospedaliera Vittorio Emanuele, Catania, Italy Azienda Ospedaliera Santa Maria, Terni, Italy Azienda Ospedaliera San Andrea, Rome, Italy Azienda Ospedaliera Universita` San Martino di Genova,Genoa, Italy G. M. BuonannoAzienda Ospedaliera San Giuseppe Moscati, Avellino, Italy A. MarvasoP.O.S. Anna Rizzoli, A.S.L. Napoli 2, Lacco Ameno, Italy G. Campanelli Á M. CavalliUniversita` dell’Insubria di Varese, I.R.C.C.S. Multimedica, Ospedale Generale di Zona San Giuseppe Sambiasi, Nardo, Italy Seconda Universita` degli Studi di Napoli, Naples, Italy Ospedale Santi Carlo e Donnino, Pergola, Italy P.O. Unico Villa Malta, A.S.L. Salerno, Sarno, Italy A.O. Policlinico Umberto, Viale del Policlinico, 190,00133 Rome, Italy G. Coscarella Á N. Di Lorenzo Á A. L. Gaspari Dipartimento di Scienze Chirurgiche,Universita` di Roma Tor Vergata, Rome, Italy P \ 0.001). At 1 month, significantly fewer patients in the with TissucolÒ/TisseelÒ fibrin glue (Baxter Healthcare, fibrin glue group reported pain, numbness, and discomfort Deerfield, IL, USA) as a means of mesh fixation in hernia compared with patients in the sutures group (all P \ 0.05).
repair have shown promising results [, –, Fibrin glue patients also experienced less intense pain (0.6 The Lichtenstein technique is a standard procedure for vs. 1.2; P = 0.001). By 3 months, the between-group dif- open tension-free inguinal hernia repair performed using ferences had disappeared, except for numbness, which was prosthetic meshes to strengthen the inguinal canal posterior more prevalent in the sutures group. By 12 months, very wall Postoperative quality of life and the rate of few patients reported complications.
postoperative complications are dependent on the type of Tissucol fibrin glue for mesh fixation in the mesh and method of fixation [, as well as metic- Lichtenstein repair of inguinal hernia shows advantages ulous surgical technique. Importantly, hernia can recur over sutures, including lower incidence of complications with the Lichtenstein technique if mesh overlap around the such as pain, numbness, and discomfort, and should be hernia orifice is inadequate [Therefore, high-quality considered as a first-line option for mesh fixation in fixation methods should be used to properly secure the mesh until it is incorporated into the patient’s own tissue.
The purpose of our study was to investigate the frequency Inguinal hernia Á Tension-free hernia repair Á and severity of postoperative pain and other complications Human fibrin glue Á Tissucol/Tisseel Á Mesh fixation Á when prosthetic mesh is fixed by using fibrin glue com- pared with conventional sutures in inguinal hernioplastyperformed by the Lichtenstein technique.
The increasing use of mesh procedures in inguinal herniasurgery has led to a substantial decrease in the incidence of hernia recurrence. As a result, surgeons (and, increasingly,their patients) are now focused on other measures reflecting This was a prospective observational study carried out in the success of hernia repair. The prevalence of postopera- 16 centers across Italy with extensive experience in hernia tive pain syndromes after open and laparoscopic proce- surgery. Male or female patients aged over 18 years of age dures has been reported to be as high as 30% and some with a primary unilateral uncomplicated inguinal hernia analyses estimate that 12% of patients feel themselves suitable for Lichtenstein repair were eligible for enrolment.
to be restricted in their daily activities because of pain.
Exclusion criteria included femoral or incarcerated hernia, Clinical studies have shown that both recurrence and the need for other abdominal procedure, body mass index chronic pain after endoscopic hernia repair are influenced (BMI) C 35 kg/m2, diabetes, immunological or coagula- by the type of mesh implanted and its method of fixation tion disorders, warfarin or clopidogrel therapy, steroid [–]. The ideal mesh fixation should produce no structural therapy for long-term pain control, hypersensitivity to damage and be biocompatible in order to reduce the risk of aprotinin, history of drug/alcohol abuse, and psychiatric hematoma and seroma Conventionally, the mesh disorders. Patients received either sutures or fibrin glue for prosthesis is secured by either sutures or staples. Despite mesh fixation based on the preference of the operating the ‘‘tension-free’’ nature of these hernioplasties, sutures and staples may strangulate muscle fibers, compress Ethics committee approvals were obtained from the regional nerves, or give rise to a lesion, leading to inca- participating institutions and informed consent was sought Complications associated with sutured mesh fixation following open groin hernia repair have prompted surgeons to evaluate methods of atraumatic fixation, such as the useof human fibrin glue. Fibrin glue is a biodegradable adhesive combining human-derived fibrinogen and throm-bin that replicates the last step of the coagulation cascade.
A polypropylene mesh was trimmed to fit the floor of the It has been used in a variety of surgical fields for its inguinal canal, and its apex was sutured to the pubic effectiveness, excellent local tolerability, and relative lack tubercle using a No. 3–0 Prolene suture. The same con- of adverse effects and contraindications. Its adhesive and tinuous suture was used to join the lower border of the hemostatic properties have been demonstrated in a number mesh to the free edge of the inguinal ligament, after an of experimental studies and clinical trials []. Studies opening was made into its lower edge to accommodate the spermatic cord. The continuous suture was extended up just 520 patients, with the fixation of mesh achieved with either medial to the anterior superior iliac spine. Interrupted fibrin glue (349 patients) or sutures (171 patients). Baseline Prolene sutures were used to suture the two cut edges of the demographic and clinical characteristics were similar mesh together around the spermatic cord. The inferomedial between the treatment groups (Table Our study inclu- corner of the mesh was attached, overlapping the pubic ded 484 (93%) male and 36 (7%) female patients with a tubercle. The mesh was anchored to the conjoined tendon mean age of 55 years (range 18–90); 70% of patients were by interrupted sutures (Prolene 3–0). The external oblique workers or active pensioners. The mean (±SD) VAS pain aponeurosis was closed using absorbable sutures (Vicryl intensity score in the preoperative phase was 2.9 (±2.0), with no significant difference between the study groups.
In 288 (55%) of patients, inguinal hernias were right- sided, 223 (43%) had left-sided hernias, and 9 (2%) hadbilateral hernias, giving a total of 529 hernias. At surgery, Fibrin glue alone was sufficient for polypropylene mesh hernias were classified according to the European Hernia fixation, without the need for additional sutures. Fibrin glue Society (EHS) criteria ]: 164 (32%) were L1, 191 (37%) was applied using either a needle or a spray applicator.
L2, 5 (1%) L3, 65 (13%) M1, 100 (19%) M2, and 3 (1%) Surgeons were permitted to use either application method, Of the 520 patients, 470 (90%) completed follow-up visits at 1, 3, 6, and 12 months. Fifty patients discontinued the study, 33/349 (9%) from the fibrin glue group and 17/171 (10%) from the sutures group. Of these 50 patients, 24 The prevalence of inguinal pain, numbness, and discomfort did not attend follow-up visits, one withdrew due to were assessed at hospital discharge until 1 month post- adverse events, one died (cardiac arrest), and 24 discon- surgery (to determine early postoperative outcomes) and at 1-, 3-, 6-, and 12-month follow-up visits (to determine themedium- to long-term outcomes) via structured interviews with clinical report forms. A visual analog scale (VAS) wasused to gauge patient pain intensity, ranging from 0 = no Surgery parameters were similar between the treatment pain to 10 = worst pain. Recurrence due to technical groups, with the exception of the mean operating time, errors, hematoma, ecchymosis, other complications (e.g., which was significantly shorter in patients receiving fibrin seroma, infection), use of analgesia and antibiotics, and glue compared with those receiving sutures (55.6 vs.
time to return to normal activity were assessed. The eval- 61.2 min, P \ 0.001) (Table ). Fibrin glue was applied uators were not blinded to treatment. At the time of oper- using a needle in 52% of patients and a spray device in ation, surgeons assessed the ease of use of fibrin glue 46% of patients (data missing for 2% of patients). In the application through a score ranging from 1 = very easy to fibrin glue group, 67% of patients received 1 mL glue, 23% received 2 mL, and 6% received 5 mL (data missing for4% of patients). The mean VAS score for the ease of fibrin glue application was 1.8 ± 0.8, indicating a high level ofease among surgeons when using Tissucol.
Descriptive statistics were calculated. Differences betweenthe study groups in terms of the proportions experiencing postoperative pain, numbness, discomfort, and recurrencedue to technical errors were analyzed by the Chi-squared During the early postoperative phase (at hospital discharge test. Continuous variables such as pain intensity and time until 1 month postsurgery), 305/349 (87.4%) of patients in to return to normal activity were analyzed by the Mann– the fibrin glue group and 131/171 (76.6%) of patients in the sutures group were free of complications (P = 0.001;Table Patients in the fibrin glue group were also lesslikely to experience hematoma (1.7 vs. 8.2%) and ecchy- mosis (8.6 vs. 15.2%) than patients in the sutures group(both P = 0.001).
The mean VAS score for the intensity of pain reported by patients was significantly lower in the fibrin group Operations took place from January 2007 to January 2008.
compared with the sutures group (2.5 vs. 3.2, P \ 0.001).
Tension-free repair of inguinal hernia was performed in The use of analgesics in the postoperative period was COPD chronic obstructivepulmonary disease; VAS visual similar between groups, with around 64% requiring pain two cases of direct hernias in the fibrin group at the 3- month assessment. In both cases, the fibrin glue had been Fewer patients in the fibrin glue group reported numb- sprayed and recurrence was attributed to procedural errors, ness than in the sutures group (12.3 vs. 23.4%, P = 0.003).
i.e., inadequate size of the polypropylene mesh.
Discomfort was reported in 46.5% of patients, with no Figure summarizes the percentage of patients who differences evident between groups. Six complications were suffering from numbness before and after surgery. At occurred: two fever cases (one in each study group), two 1 month, significantly fewer patients in the fibrin glue scrotal hematoma cases (one in each study group), one group reported pain, numbness, and discomfort compared seroma (sutures group), and one case of abdominal pain with patients in the sutures group (all P \ 0.05; Table ; (fibrin glue group). More patients in the sutures group Fig. ). The fibrin glue group patients also experienced less received antibiotics than in the fibrin glue group (85.4 vs.
intense pain (mean VAS score 0.6 vs. 1.2; P = 0.001; 65.6%, P \ 0.001). No significant difference between Fig. ). Fewer than 1% of patients required analgesia. By groups was noted with regard to the length of hospital stay.
3 months, these between-group differences had disap-peared, with the exception of numbness, which continued to be more prevalent in the sutures group than in the fibringlue group (13.7 vs. 4.1%, P \ 0.001; Fig. ).
As shown in Table , there were no recurrences due to The prevalence of complications continued to decrease technical complications throughout the study, except for throughout the follow-up period, as expected, with no Table 3 Postoperative complications at hospital discharge and other variables Objective examination, no. of patients (%)a Postoperative hospital stay, mean ± SD (days) All P-values were derived from Chi-squared testing, except pain intensity, which were derived from Mann–Whitney U testing SD standard deviation, VAS visual analog scale ranging from 0 (no pain) to 10 (worst pain), NSAIDs non-steroidal anti-inflammatory drugsa Some patients had more than one complication; data were missing for 13 patients between-group differences evident at 6 and 12 months continued to be significantly more prevalent in the sutures follow-up. By 12 months, very few patients in either study group, but the between-group differences in all of the other group reported pain, numbness, or discomfort (Table outcome measures had disappeared. Complications con-tinued to decrease in both study groups throughout the12-month follow-up period, such that only a handful of This prospective, observational, multicenter study com- Our findings are largely consistent with the published pared fibrin glue versus conventional sutures for mesh studies of Tissucol versus sutures for mesh fixation in fixation in the Lichtenstein repair of inguinal hernia.
Lichtenstein hernia repair ]. A controlled study by The mean operating time was reduced by around 9% in Hidalgo et al. [assessed mesh fixation using fibrin the fibrin glue study group relative to the sutures group sealant compared with sutures in 55 patients with bilateral (P \ 0.001) and the mean VAS score for the ease of fibrin inguinal hernias, in whom mesh fixation was undertaken glue application was 1.8 (possible score 1–10, with with sutures on the right hernia and with glue on the left 10 = most difficult), indicating a high level of ease among hernia. Similar overall outcomes were reported in both surgeons when using Tissucol. Patients in the fibrin glue inguinal regions, but there was less postoperative pain and group were also less likely to experience early local hem- less inflammatory reaction associated with fibrin-fixed orrhagic complications (e.g., hematoma, ecchymosis) than hernia repairs. Two patients reported pubic pain at 6 months, but were free of pain by 12 months; no other At 1 month assessment, patients in the fibrin glue study early or late complications were observed. In an uncon- group reported significantly less pain, numbness, and dis- trolled study, Canonico et al. assessed the use of fibrin comfort compared with patients in the sutures group. There sealant in 80 patients who had undergone sutureless Lich- were no differences in the days of sickness absence tenstein repair of primary unilateral hernia, with Tissucol as between the two study groups. At 3 months, numbness a means of mesh fixation. No complications were observed Table 4 Complications experienced during the 12-month follow-up period 34 (19.9%) 14 (4.1%)*** 23 (13.7%) 10 (3.0%) All P-values were derived from Chi-squared testing, except pain intensity and days of sickness absence, which were derived from Mann–Whitney U testing VAS visual analog scale ranging from 0 (no pain) to 10 (worst pain); SD standard deviation **** P = 0.028 versus sutures group  One seroma, one unspecifiedà Two scrotal hematomas, one seroma, one fever, one sporadic dysejaculation Fig. 1 Percentage of patientssuffering from numbness beforeand after surgery over 12 months. More definitive conclusions about the compared the 12-month rate of disabling complications effectiveness of fibrin glue in reducing the rate of postop- (chronic pain/numbness/groin discomfort) following mesh erative complications following Lichtenstein repair comes fixation with Tissucol or sutures in patients with inguinal from the TIMELI (TIssucol/TIsseel for MEsh fixation in hernia undergoing Lichtenstein repair []. At 12 months, LIchtenstein hernia repair) study. This international, con- the prevalence of C1 disabling complication was signifi- trolled, randomized, patient- and evaluator-blinded study cantly lower in the Tissucol group than in the sutures group Fig. 2 Pain intensity asassessed by the visual analogscale (VAS) score before andafter surgery (8.1 vs. 14.8%; P = 0.034) [Less numbness and groin accompanied by reduction in postoperative inguinal pain.
discomfort were also noted in the Tissucol versus sutures Consequently, fibrin glue should be considered as a first- group (P = 0.019; P = 0.049); only 3/316 patients (0.94%) line option over sutures for mesh fixation in inguinal hernia experienced recurrence (one Tissucol, two sutures).
The notion that fibrin glue fixation is associated with less postoperative pain versus suturing is quite conceivable The authors declare that they have no conflicts considering the procedural differences between the twoapproaches. Suturing the upper edge of the prosthetic meshto the internal oblique aponeurosis results in markedretraction of the external oblique aponeurosis, subcutane- ous fat, and skin as the needle passes. In contrast, minimaltissue retraction is necessary with fibrin glue fixation. More 1. Bay-Nielsen M, Perkins FM, Kehlet H (2001) Pain and functional soft tissue retraction naturally leads to greater contusion impairment 1 year after inguinal herniorrhaphy: a nationwide and short-term pain. Therefore, consistent with our results, less soft tissue contusion and associated postoperative pain 2. Aasvang E, Kehlet H (2005) Surgical management of chronic pain after inguinal hernia repair. Br J Surg 92:795–801 seems probable with fibrin glue fixation compared with 3. Katkhouda N, Mavor E, Friedlander MH, Mason RJ, Kiyabu M, Grant SW, Achanta K, Kirkman EL, Narayanan K, Essani R In terms of study weaknesses, our study was not ran- (2001) Use of fibrin sealant for prosthetic mesh fixation in lap- domized or blinded and no formal power calculations were aroscopic extraperitoneal inguinal hernia repair. Ann Surg233:18–25 undertaken. Patients were allocated to sutures or fibrin glue 4. Junge K, Rosch R, Krones CJ, Klinge U, Mertens PR, Lynen P, by the operating surgeon as per routine practice; however, Schumpelick V, Klosterhalfen B (2005) Influence of polygleca- both study groups were similar in terms of clinical and prone 25 (Monocryl) supplementation on the biocompatibility of demographic characteristics at baseline. The relatively a polypropylene mesh for hernia repair. Hernia 9:212–217 5. Amid PK (1997) Classification of biomaterials and their small study population limits the generalization of the related complications in abdominal wall hernia surgery. Hernia findings, and the 12-month follow-up period is too short to provide meaningful information on chronic pain or hernia 6. Campanelli G, Champault G, Pascual MH, Hoeferlin A, Kings- recurrence with mesh fixation by fibrin glue versus sutures.
north A, Rosenberg J, Miserez M (2008) Randomized, controlled,blinded trial of Tissucol/Tisseel for mesh fixation in patients Nonetheless, in summary, our study suggests that using undergoing Lichtenstein technique for primary inguinal hernia fibrin glue to fix mesh in inguinal hernia repair results in repair: rationale and study design of the TIMELI trial. Hernia significantly less pain, numbness, and discomfort than fixation with sutures during the early postoperative period 7. Canonico S, Santoriello A, Campitiello F, Fattopace A, Corte AD, Sordelli I, Benevento R (2005) Mesh fixation with human (at hospital discharge until 1 month postsurgery). This is a fibrin glue (Tissucol) in open tension-free inguinal hernia repair: period that many would regard as the most critical period in which patients experience the most negative impact on the 8. Katkhouda N (2004) A new technique for laparoscopic hernia repair using fibrin sealant. Surg Technol Int 12:120–126 9. Lau H (2005) Fibrin sealant versus mechanical stapling for mesh Mesh fixation with fibrin glue in open tension-free fixation during endoscopic extraperitoneal inguinal hernioplasty: Lichtenstein hernia repair is a simple technique that is a randomized prospective trial. Ann Surg 242:670–675 10. Alfieri S, Di Miceli D, Doglietto GB (2007) Prophylactic ilioin- of Tisseel for mesh fixation in patients undergoing Lichtenstein guinal neurectomy in open inguinal hernia repair. Ann Surg technique for inguinal hernia repair: the TIMELI trial. Hernia 13(Suppl 1). Abstract presented at the 4th Joint Meeting of the 11. Canonico S (2003) The use of human fibrin glue in the surgical American Hernia Society (AHS) and the European Society Her- operations. Acta Biomed 74(Suppl 2):21–25 nia (EHS), Berlin, Germany, 9–12 September 2009 12. Ferna´ndez Lobato R, Garcı´a Septiem J, Ortega Deballon P, 16. Amid PK (2004) Lichtenstein tension-free hernioplasty: its Martı´n Lucas FJ, Ruı´z de Adana JC, Limones Esteban M (2001) inception, evolution, and principles. Hernia 8:1–7 Tissucol application in dermolipectomy and incisional hernia 17. Gilbert AI, Graham MF, Voigt WJ (1999) A bilayer patch device for inguinal hernia repair. Hernia 3:161–166 13. Zieren J, Castenholz E, Baumgart E, Mu¨ller JM (1999) Effects of 18. Miserez M, Alexandre JH, Campanelli G, Corcione F, Cuccurullo fibrin glue and growth factors released from platelets on D, Pascual MH, Hoeferlin A, Kingsnorth AN, Mandala V, Palot abdominal hernia repair with a resorbable PGA mesh: experi- JP, Schumpelick V, Simmermacher RK, Stoppa R, Flament JB (2007) The European Hernia Society groin hernia classification: 14. Olmi S, Erba L, Bertolini A, Scaini A, Mastropasqua E, Conti M, simple and easy to remember. Hernia 11:113–116 Croce E (2005) Use of fibrin glue (Tissucol) for mesh fixation in 19. Hidalgo M, Castillo MJ, Eymar JL, Hidalgo A (2005) Lichten- laparoscopic transabdominal hernia repair [in Italian]. Chir Ital 15. Campanelli G, Hidalgo M, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A, Miserez M (2009) Randomized controlled trial

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