Post-operative benefits of Tisseel(®)/Tissucol (®) for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial.

PURPOSE: The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair (TIMELI) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate-severe complications of pain 12 months post-operatively compared with sutures. Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention. METHODS: Univariate and multivariate analyses identified risk factors for combined pain, numbness and groin discomfort (PND) visual analogue scale (VAS) score 12 months post-operatively. Variables tested were: fixation method, age, employment status, physical activity, nerve handling, PND VAS score at pre-operative visit and 1 week post-operatively. The effect of fixation technique on separate PND outcomes 12 months post-surgery was also assessed. Analyses included the intention-to-treat (ITT) population and a subpopulation with pre-operative PND VAS > 30 mm. RESULTS: 316 patients were included in the ITT, with 130 patients in the subpopulation with pre-operative PND VAS > 30. Multivariate analysis identified mesh fixation with sutures, worsening pre-operative PND and worsening PND 1 week post-surgery as significant predictors of 12-month PND in the ITT population; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation (p < 0.05). Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12 months; there was no difference in pain between the treatment groups. CONCLUSIONS: Pre-operative discomfort may be an important predictor of post-operative pain, numbness and discomfort. Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients.

Recommendations for reporting outcome results in abdominal wall repair: results of a Consensus meeting in Palermo, Italy, 28-30 June 2012.

BACKGROUND: The literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology. MATERIALS AND METHODS: The EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction. RESULTS: A list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of "time-to-event analysis" to report data on "freedom-of-recurrence" rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods. CONCLUSION: A set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.

PerFix™ plug versus 4DDOME(®) implants for inguinal hernia repair: prospective multicentric randomised controlled trial.

INTRODUCTION: Anterior mesh placement is the standard of care for hernia repair. The use of partially absorbable meshes may limit post-operative pain without altering the durability of the repair. We designed a prospective randomised study, which aims to compare the PerFix™ plug to the 4DDOME(®), a partially absorbable mesh. MATERIALS AND METHODS: Inguinal hernia patients were prospectively and randomly included in the study. Hernia repair was performed using either the PerFix™ plug (Davol) or the 4DDOME(®) implant (Cousin Biotech). Operative evaluation included type and duration of anaesthesia, characteristics of the incision, post-operative hospital stay and pain evaluated through a visual analogue scale (VAS) at day 1, day 8, month 1, month 6, and year 1. Return to personal or professional activity was evaluated. Quality of life was measured by a SF36 questionnaire at 1, 6, and 12 months' follow-up. RESULTS: Ninety-five patients were prospectively enrolled and randomised to one type of prosthetic repair. The two groups of patients did not differ in terms of clinical characteristics, type of hernia, and intra-operative course. When comparing PerFix™ plug to 4DDOME(®) groups, the post-operative course was similar: pain (VAS 3.42 (SD 1.83) vs. 3.82 (SD 2.0), p = 0.69); in-hospital stay (2.12 (SD 1.36) vs. 2.25 (SD 1.62), p = 0.67); and return to personal (9.39 days (SD 8.15) vs. 9.48 days (SD 11.68), p = 0.96) and professional activity (25.71 days (SD 17.47) vs. 22.82 days (SD 18.10), p = 0.62). Post-operative pain and discomfort assessed by the SF36 questionnaire at day 8, months 1, 6, and 12 were similar, but significantly lower after 4DDOME(®) repair at 3 months for "pain" (p = 0.021) and at 6 months for "health" criteria (p = 0.028). CONCLUSION: This clinical study demonstrated similar short-term results. The 4DDOME(®) was associated with less pain and discomfort after 3 and 6 months. The combination of the dome shape and the double component mesh including an absorbable part meet the conflicting demands of early strength with a long-term low-weight material to minimise shrinkage and fibrosis. This design represents a potential advance in anterior tension-free hernia repair with mesh.

EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair.

BACKGROUND: Although the repair of ventral abdominal wall hernias is one of the most commonly performed operations, many aspects of their treatment are still under debate or poorly studied. In addition, there is a lack of good definitions and classifications that make the evaluation of studies and meta-analyses in this field of surgery difficult. MATERIALS AND METHODS: Under the auspices of the board of the European Hernia Society and following the previously published classifications on inguinal and on ventral hernias, a working group was formed to create an online platform for registration and outcome measurement of operations for ventral abdominal wall hernias. Development of such a registry involved reaching agreement about clear definitions and classifications on patient variables, surgical procedures and mesh materials used, as well as outcome parameters. The EuraHS working group (European registry for abdominal wall hernias) comprised of a multinational European expert panel with specific interest in abdominal wall hernias. Over five working group meetings, consensus was reached on definitions for the data to be recorded in the registry. RESULTS: A set of well-described definitions was made. The previously reported EHS classifications of hernias will be used. Risk factors for recurrences and co-morbidities of patients were listed. A new severity of comorbidity score was defined. Post-operative complications were classified according to existing classifications as described for other fields of surgery. A new 3-dimensional numerical quality-of-life score, EuraHS-QoL score, was defined. An online platform is created based on the definitions and classifications, which can be used by individual surgeons, surgical teams or for multicentre studies. A EuraHS website is constructed with easy access to all the definitions, classifications and results from the database. CONCLUSION: An online platform for registration and outcome measurement of abdominal wall hernia repairs with clear definitions and classifications is offered to the surgical community. It is hoped that this registry could lead to better evidence-based guidelines for treatment of abdominal wall hernias based on hernia variables, patient variables, available hernia repair materials and techniques.

Laparoscopic repair of intraperitoneal bladder perforation due to indwelling urethral catheter.

Intraperitoneal perforation can occur as a rare but life threatening complication of indwelling urethral catheters. Computed tomography (CT) revealed the bladder perforation by the Foley catheter. The injury could not be managed conservatively due to the presence of systemic infection. We present the case of a successful laparoscopic repair of the bladder due to indwelling urethral catheter.

Is fixation during gastric banding necessary? A randomised clinical study.

Anterior fixation via a gastro-gastric suture in laparoscopic adjustable gastric banding (LAGB) is commonly performed to prevent band-related complications. However, the necessity of this common technique has never been proven. Not fixing the band would be time sparing and would reduce adhesions on the stomach and probably make revisional surgery easier. This study was conceived as a 3-year randomised clinical trial to test the safety and efficacy of the non-fixation technique. From December 2006 to December 2007, 81 patients undergoing LAGB were randomly distributed into two groups: group A, with gastro-gastric sutures (n = 41) and group B, without gastro-gastric fixation (n = 40). The two groups were equivalent regarding initial body mass index (BMI), age and sex ratio. The main outcome was postoperative complications and secondary outcomes were operative time and weight loss expressed by the percentage of excess BMI loss (%EBMIL). All patients were prospectively followed up for 2 years. The mean preoperative BMI was 42.5 kg/m² (35-56). All patients were available for follow-up at 2 years. The mean overall preoperative time was 82 ± 20 min for the fixation group and 72 ± 20 min for the non-fixation group (p = 0.13). The mean hospital stay was 4.1 ± 1.5 days (no significant difference between the two groups). The 2-year %EBMIL was 35.9 for group A and 39.4 for group B (p = NS). The mean BMI at 2 years was 36.3 and 36.1, respectively, with no statistical difference. We observed three early band slippages in the non-fixation group and none in the fixation group. Three bands were removed during the second year of follow-up for causes other than band slippage (no significant difference between the two groups). This study was interrupted before a statistical significance could be reached, under the general agreement of all participating surgeons, because of the three unexpected early band slippages. For the patients who did not suffer from this complication, we did not observe any differences between the two groups in terms of late complications and weight loss. The operative time was shorter in the non-fixation group. This randomised clinical trial suggests that care should be taken when not fixating the LAGB because of the risk of early postoperative band slippage. We suggest that fixing the LAGB by gastro-gastric sutures should remain common practice.

A self-adhering mesh for inguinal hernia repair: preliminary results of a prospective, multicenter study.

BACKGROUND: Prosthetic reinforcement is the gold standard treatment for inguinal hernia and reduces the risk of recurrence. Yet up to one-third of patients complain of post-surgical pain due to irritation and inflammation caused by the mesh and the fixation materials. Of these patients, 3-4% will experience severe and disabling chronic pain. We performed a prospective multicenter clinical study of a self-adhering prosthesis, consisting of a lightweight polypropylene mesh (40 g/m²) coated on each side with synthetic glue, to evaluate early postoperative complications and patient outcomes. PATIENTS AND METHODS: Between August 2008 and June 2010, 186 patients underwent hernia repair using the Lichtenstein technique and the self-adhering prosthesis. Primary endpoints were the frequency of disabling complications and quality of life (QoL) at 3-month follow-up. Pain, numbness, and groin discomfort were evaluated pre- and postoperatively (1 week, 1 and 3 months) using a visual analogue scale (VAS). Patients' pre- and postoperative QoL were measured using the SF12 questionnaire. Secondary endpoints were number of complications and recurrence rate, use of analgesic drugs, length of hospital stay, delay to return to normal activities, and patient satisfaction. The quality of the self-adhering mesh and its clinical utility were also evaluated by the participating surgeons. RESULTS: A total of 186 patients were enrolled and followed for at least 3 months after inguinal hernia repair. A total of 174 (95%) primary hernias and 12 (5%) recurrent hernias were treated. There were no intraoperative complications, no recurrences, and no repeat interventions performed during the study. The post-surgical complication rate was 4.5%. The mean delay to recover normal physical activity was 4 days. For the primary endpoint of pain, a VAS of zero was reported by 93/184 (50.5%) patients at 1 week, 130/171 (76.0%) patients at 1 month and 119/132 (90.2%) patients at 3 months' follow-up (P < 0.0001). The postoperative SF12 scores showed a significant improvement in patient QoL following surgery (P < 0.0001). CONCLUSIONS: Adhesix( ® ) self-adhering mesh for prosthetic reinforcement following inguinal hernia repair is atraumatic and associated with infrequent post-surgical complications or pain, a rapid recovery rate, and a high patient-reported QoL. A longer follow-up is underway to assess the frequency of post-surgical recurrence.

Herniation of the gallbladder within a hernia of the abdominal wall associated with Mirizzi Syndrome.

A gallbladder incarcerated hernia associated with Mirizzi syndrome is a very rare entity and to our knowledge this is the first case ever described in literature. An 85-year-old man presented at the emergency department with a tender right upper quadrant mass. Computed Tomography (CT) revealed the presence of a gallbladder lithiasis with signs of acute cholecystitis, herniated through the abdominal wall with an associated Mirizzi syndrome. Laparoscopic cholecystectomy and repair of the abdominal wall defect were performed. The patient recovered very well and the postoperative period was uneventful.

Papillary carcinoma of the thyroglossal duct cyst: report of two cases.

AIM: To present two cases of papillary carcinoma of the thyroglossal duct cyst (TDC) and to report their management. PATIENTS AND METHODS: Two patients, a 47-year-old woman and a 60-year-old man, were operated in 2006 and 2008 in the Department of Digestive and Metabolic Surgery of the "Jean Verdier" Hospital. RESULTS: The diagnosis of papillary carcinoma was established after the pathological examination carried out on the thyroglossal duct cyst, after its complete surgical excision. A total thyroidectomy followed by a treatment by radioactive iodine and a substitutive hormonal therapy were carried out in the second time for one of the two patients. For the other patient, a total thyroidectomy followed by a substitute hormonal therapy, were achieved. The evolution was favorable, with a follow-up of four years for the first patient and two years for the second one. DISCUSSION: Total thyroidectomy after the complete excision of the cyst is currently the recommended treatment for the papillary carcinoma of the TDC. It was shown that a latent thyroid cancer could develop even 15 years after the initial excision of the thyroglossal cyst. The treatment is curative in 95% of the cases. CONCLUSIONS: Current treatment of papillary carcinoma of the thyroglossal duct cyst is well codified, allowing an excellent prognostic.

Classification of primary and incisional abdominal wall hernias.

PURPOSE: A classification for primary and incisional abdominal wall hernias is needed to allow comparison of publications and future studies on these hernias. It is important to know whether the populations described in different studies are comparable. METHODS: Several members of the EHS board and some invitees gathered for 2 days to discuss the development of an EHS classification for primary and incisional abdominal wall hernias. RESULTS: To distinguish primary and incisional abdominal wall hernias, a separate classification based on localisation and size as the major risk factors was proposed. Further data are needed to define the optimal size variable for classification of incisional hernias in order to distinguish subgroups with differences in outcome. CONCLUSIONS: A classification for primary abdominal wall hernias and a division into subgroups for incisional abdominal wall hernias, concerning the localisation of the hernia, was formulated.

[Is bariatric surgery in adolescents appropriate?]. / La chirurgie bariatrique chez l'adolescent est-elle légitime?

Current recommendations for bariatric surgery are limited to patients older than 18 years. Two studies in 2007 showed that bariatric surgery improves survival in adults. Medical management of severe obesity in adolescents is all too often ineffective. For these reasons, early surgical intervention for adolescents with morbid obesity may be expected to prevent or avoid comorbidities, decrease mortality, and improve the quality of life. Several studies have demonstrated the feasibility of adolescent bariatric surgery with morbidity comparable to that seen in adult series. The earlier the surgery, the better the result in terms of prevention or reversal of comorbid conditions. In the USA, a consensus definition of adolescents eligible for bariatric surgery specifies attainment of Tanner Stage IV of sexual maturity and achievement of 95% of axial growth. Just as in adults, bariatric surgery in adolescents requires prolonged follow-up; it is important that such surgery be performed in centers specialized in adult bariatric surgery having the necessary multidisciplinary structure.

A "self adhering" prosthesis for hernia repair: experimental study.

BACKGROUND: Prosthetic reinforcement is now routine in the management of inguinal and incisional hernia, and it significantly reduces the risk of recurrence. After surgery, chronic pain is often attributed to the characteristics of the mesh and to the method of fixation in the wound, with a potential risk of nerve or muscle injuries. AIM: To evaluate the properties of a new "self adhering" prosthesis in an experimental animal study. MATERIALS AND METHODS: The self adhering prosthesis, a lightweight (40 mg/m(2)) polypropylene mesh coated with a synthetic glue on one side, was implanted laparoscopically in pigs. Removal of the prosthesis was performed at one day, one week and one month post operatively. A macroscopic and microscopic evaluation was performed. The results, using a quantitative score, were compared to those of a control group using the same polypropylene mesh without glue, but fixed by staples. RESULTS: The operative time was significantly lower in the self adhering group: 23 min (15-32) versus 31 min (21-40) (P = 0.01). The average time interval from the introduction of the mesh into the preperitoneal space until the appearance of the first tough adhesion was 3 min (2-4). In the control group, the mesh handling time was 8.3 min (5-14) (P = 0.01). At the time of implantation, the score was at a maximum value in all cases for the self adhering prostheses, especially concerning handling and adhesiveness. Upon removal, this score was noted to be good or very good in 90-100% of the cases. There was a good integration in the muscle confirmed histologically, and there was no shrinkage, no mobilisation and no migration. At one month, the thickness of the fibrosis at the limits of the meshes was significantly higher for the self adhering prostheses (P = 0.02). CONCLUSION: In this experimental study, the self adhering prosthesis demonstrated its adhesive properties and its ability to be well tolerated, with a good macroscopic and microscopic integration into the abdominal wound. This should allow us to perform a clinical prospective study in an open and laparoscopic approach with the double objective of reducing post operative pain induced by mechanical fixation and decreasing the cost of these procedures by reducing the operative time and by eliminating staple fixation.

[Evaluation of stress in surgical trainees: prospective study of heart rate during laparoscopic cholecystectomy]. / Stress des chirurgiens en formation: Etude prospective de la cardio-fréquence lors de cholécystectomies laparoscopiques.

INTRODUCTION: Surgical training is stressful, particularly in the operating room setting. The purpose of the study is to evaluate and quantitate intra-operative stress in surgical trainees. MATERIAL: and methods: Cardiac rate was used as a measure of stress during surgical cases; surgical residents serving as the primary surgeon and assistant during 21 laparoscopic cholecystectomies underwent telemetry monitoring. RESULTS: Intra-operative cardiac rate increased by 4-10%, particularly in the resident serving as primary surgeon. The most stressful moments of the procedure were the draping of the surgical field, trocar placement, clip application, and extraction of the gallbladder. CONCLUSION: This study offers a measure of the stress of surgical residents in the operating room. Heart rate is not the ideal parameter of stress, yet it gives a good idea of the level of stress. The identification of stress-inducing factors may help residents to deal with difficult situations.

Tracheal intubation of morbidly obese patients: a randomized trial comparing performance of Macintosh and Airtraq laryngoscopes.

BACKGROUND: The Airtraq laryngoscope is designed to allow visualization of the glottis without alignment of the oral, pharyngeal, and laryngeal axes. We hypothesized that this new airway device would facilitate tracheal intubation of morbidly obese patients. We compared tracheal intubation performance of standard Macintosh laryngoscope with the Airtraq laryngoscope in morbidly obese patients. METHODS: One hundred and six consecutive ASA I-III morbidly obese patients undergoing surgery were randomized to intubation with the Macintosh laryngoscope or the Airtraq laryngoscope. Induction of anaesthesia was standardized. If tracheal intubation failed within 120 s with the Macintosh or Airtraq , laryngoscopes were switched. Success rate, SpO2, duration of tracheal intubation, and quality of airway management were evaluated and compared between the groups. RESULTS: Preoperative characteristics of the patients were similar in both groups. In the Airtraq group, tracheal intubation was successfully carried out in all patients within 120 s. In the Macintosh laryngoscope group, six patients required intubation with the Airtraq laryngoscope. The mean (SD) time taken for tracheal intubation was 24 (16) and 56 (23) s, respectively, with the Airtraq and Macintosh laryngoscopes, (P<0.001). SpO2 was better maintained in the Airtraq group than in the Macintosh laryngoscope group with one and nine patients, respectively, demonstrating drops of SpO2 to 92% or less (P<0.05). CONCLUSIONS: In this study, the Airtraq laryngoscope shortened the duration of tracheal intubation and prevented reductions in arterial oxygen saturation in morbidly obese patients.

Randomized, controlled, blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: rationale and study design of the TIMELI trial.

BACKGROUND: Complications associated with sutured mesh fixation following open groin hernia repair have prompted surgeons to evaluate methods of atraumatic fixation such as the use of human fibrin glue. Small trials with Tissucol/Tisseel fibrin glue (Baxter Healthcare, Deerfield, IL, USA) have shown promising results that warrant further investigation. METHODS: TIMELI (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair) is an international, controlled, randomized, patient- and evaluator-blinded study that is comparing mesh fixation with Tissucol or sutures in patients with inguinal hernia. The primary endpoint evaluates the incidence of disabling complications (chronic pain and/or numbness and/or groin discomfort) at 12 months post-surgery. RESULTS: Patient enrolment started in February 2006 and ended on 19 April 2007, with a total of 325 patients recruited. Initial results are expected in early 2008. CONCLUSIONS: TIMELI is a major international trial that will provide important information on the efficacy and safety of Tissucol, compared with sutures, for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair.

[Diaphragmatic hernias, excluding hiatal hernias with gastroesophageal reflux]. / Les hernies diaphragmatiques á l'exception des hernies hiatales avec reflux gastro-oesophagien.

Large, mixed hiatal hernias are usually found between the ages of 60 and 70 years, with a female predominance (60%). The natural history is progression toward the appearance of symptoms, although 30%-40% of patients are initially asymptomatic. Symptoms develop quietly. The indication for surgical treatment of hiatal hernias amounts to considering the risks of leaving it in place. The literature reports a morbidity and mortality rate related to the complications of these hernias, leading to emergency interventions, which have an incidence of 1.16%.with a 27% mortality rate. Morbidity appears different depending on the approach used: laparoscopy or laparotomy (4.3% versus 16%). The debate continues on whether to monitor or treat these hernias, with a lack of consensus on the indications and the technique. However, the laparoscopic approach shows a gain in the length of the hospital stay, an easier approach to the hiatus in the diaphragm, and a lower morbidity and mortality rate. Fundoplication is advised, as well as placing prosthetic mesh if the orifice is larger than 8 cm. There is no indication for lengthening the esophagus (Collis-Nissen fundoplication).

[Comparison of quality of life in morbidly obese patients and healthy volunteers. A prospective study using the GIQLI questionnaire]. / Qualité de vie des patients obèses relevant d'un traitement chirurgical comparée à celle d'une population témoin. Etude prospective utilisant le questionnaire GIQLI.

BACKGROUND: Morbid obesity decreases the quality of life. The aims of surgical and medical treatment are weight loss, reduction of co-morbidity, and improved quality of life. AIMS: To compare the quality of life between obese patients (BMI: 40 or>35+comorbidity) and healthy volunteers using the GIQLI (Gastrointestinal Quality of Life) questionnaire. PATIENTS: Between January 2001 and December 2002, 127 morbidly obese patients (109 female, 18 male) with a mean age of 40.1 years were surgically treated with laparoscopic gastric banding. Quality of life, as measured by the GIQLI questionnaire, was systematically evaluated pre-operatively. During the same period, a control group of 125 healthy volunteers of comparable age, gender, and prior surgical history were evaluated using the same questionnaire. RESULT: The two groups, while comparable in age and gender, were significantly different in terms of weight (123 vs. 66 kg), BMI (44.3 vs. 22.2) (p<0.001), co-morbidity factors (p=0.001), and professional activity (p=0.02). The mean global GICLI score was 122 for healthy individuals and 95 for morbidly obese patients. (p=0.001), and the differences were most marked in the super obese. These differences particularly involved social dysfunction, physical status, and emotional symptoms but were not significantly different for gastrointestinal symptoms. CONCLUSION: The quality of life in morbidly obese and super obese patients is significantly diminished from that of a control population. There was good correlation between the degree of obesity (BMI) and the alteration of the GIQLI global and subscales scores. Quality of life should be systematically evaluated before and after both medical and surgical therapy.