Mesh fixation in open IPOM procedure with tackers or sutures? A randomized clinical trial with preliminary results.

PURPOSE: In open intra-peritoneal onlay mesh (IPOM) hernia repair, mesh fixation can be done by tacks, sutures or fibrin glue. There are randomized controlled trials (RCTs) on laparoscopic IPOM procedure, but no RCT so far has examined mesh fixation techniques in open IPOM repair. METHODS: In a single-center RCT, 48 patients undergoing open IPOM repair of an abdominal wall hernia were included. After randomization, surgery was performed in a standardized fashion. Hernia size, extent of mesh fixation, and duration of surgery were documented. The primary endpoint was postoperative pain intensity. Secondary endpoints were: complications, length of stay, quality of life, return to work, hernia recurrence. Follow-up was 1 year in all 48 patients. RESULTS: After using tacks, mean pain intensity was 16.9, which is slightly lower than after suture fixation (19.6, p = 0.20). The duration of surgery was about the same (83 vs. 85 min). When using tack fixation, significantly more fixation points were applied as compared to sutures (19 vs. 12; p = 0.02), although mesh size was similar. The complication rate was similar (tacks: 6/28 vs. sutures: 3/20). Cost of suture fixation was about 26 €, which is markedly lower than the 180 € associated with tacks. However, surgeons clearly preferred mesh fixation with tacks, because it is more comfortable especially in small hernias. CONCLUSIONS: The present study failed to show an advantage of tacks over suture fixation and even there are more severe adverse events. Using tacks significantly increases the costs of hernia repair.

Randomized sham-controlled trial of acupuncture for postoperative pain control after stapled haemorrhoidopexy.

AIM: Haemorrhoidectomy usually causes moderate to strong postoperative pain. Chinese studies have found that acupuncture may have an analgesic effect in posthaemorrhoidectomy patients. This is the first Western study aiming assess the efficacy of acupuncture as an adjunct analgesic therapy after stapled haemorrhoidopexy. METHOD: In a randomized controlled trial, 50 patients were allocated to three groups. Conventional drug therapy (oral diclofenac and metamizol, local lidocaine) served as baseline analgesia. In the control group (n = 17) only this regimen was used. In addition to baseline analgesia, 17 patients received verum acupuncture. Sham acupuncture was performed on 16 patients. Being the primary outcome measure, pain was measured twice daily using the numerical rating scale (NRS) and compared statistically by repeated-measures analysis of variance. The study was registered (DRKS00003116). Results After verum acupuncture, pain intensity was not significantly lower when compared with conventional analgesia (primary hypothesis, P = 0.057), but was when compared to sham acupuncture (P = 0.007). In the afternoon of postoperative day 1, for example, NRS was 2.7 (SD 1.5) in the verum group, but 4.0 (1.0) in the sham group and 4.1 (1.9) under conventional analgesia. Furthermore, significantly fewer rescue analgesics were necessary if verum acupuncture was applied. Cardiovascular parameters were stable in all three groups, and no complications were recorded. CONCLUSIONS: In posthaemorrhoidectomy patients, acupuncture appears to be an effective adjunct to conventional analgesia. Further studies are necessary to confirm these observations and to refine the acupuncture technique.

Comparison of a beta-blocker and an If current inhibitor in rabbits with myocardial infarction.

AIM: We compared protective effects of a ss-adrenoceptor blocker (metoprolol; Met) and a If current (Ivabradine; Iva) in a rabbit model of myocardial infarction. METHODS: Experiments were performed on 44 adult New-Zealand-White (NZW) rabbits. The effects of either metoprolol or ivabradine were assessed 15 min after experimental occlusion of a coronary artery (CAO), 28 days after CAO (drug gavage), and in vitro hearts (Langendorff apparatus). The results were compared with sham and placebo hearts. RESULTS: Metoprolol (0.25 mg/kg) slightly reduced heart rate and left ventricular systolic function. Ivabradine (0.25 mg/kg) reduced heart rate significantly (P<0.05) (18% vs control). Both drugs provided advantages over placebo: mortality was significantly (P<0.01)smaller (6/13 Pla animals died, 2/10 Met animals, and 3/11 Iva animals), left ventricular function was better preserved after 28 days (external power; Pla; Met; Iva=56%; 76%; 74%), and dilatation (BNP) was reduced (P<0.05). In the Pla group, the ST segment was significantly (P<0.05) elevated by 0.35 mV after CAO and exhibited in 50% of the animals Q waves after 28 days, while after ivabradine or metoprolol, ST displacement and Q waves had disappeared. The uneconomic myosin isoenzyme V3 predominated in Met hearts and Iva hearts (V3/V1: 63/37% and 62/38%), while it was further increased in Pla hearts (78/21%). External efficiency was lowest in Pla hearts (1.00+/-0.50 a.u.; P<0.05) and was significantly higher both in Met hearts (4.0+/-1.8 a.u.) and in Iva hearts (3.3+/-1.6 a.u.). CONCLUSIONS: Met and Iva seem suited for the treatment of chronic myocardial infarction.

Comparison of biomaterials: three meshes and TAPP for inguinal hernia.

BACKGROUND: In laparoscopic hernia repair the use of biocompatible materials is necessary. A prospective, double-blind study was projected to compare three different meshes. METHODS: Ninety male patients with primary inguinal hernia undergoing transabdominal preperitoneal (TAPP) implant procedures were included. Three different types of mesh were tested: a monofile, heavy-weight, rigid mesh (group A), a smooth, heavy-weight variant of polypropylene (group B), and a polyglactin/polypropylene compound mesh (group C). Complications, pain development, inability to work, physical conditions, testicular volume, and blood circulation were documented. RESULTS: Convalescence in group A was slower than in groups B and C: Postoperative values of visual scales for pain development were higher, inability to work was 7.3 days longer, urologic effects were more severe, activities of everyday life were more reduced, and data of the German SF-36 Health Survey Test showed a significant reduction of physical condition (p < 0.05). CONCLUSION: The compound mesh did not create more comfort for the patients than the smooth variant of the heavy-weight polypropylene mesh.

Comparison of biomaterials in the early postoperative period.

BACKGROUND: Laparoscopic hernia repair necessitates the use of biocompatible materials. A prospective, double-blind study was conducted to compare two different polypropylene meshes. METHODS: The study included 40 men with primary inguinal hernia undergoing transabdominal preperitoneal polypropylene mesh repair. In 20 of these men, a monofile, heavy-weight, rigid mesh was implanted (group A), and in the remaining 20 men, a smooth, heavy-weight variant of polypropylene mesh was implanted (group B). Complications, pain development, inability to work, physical conditions, testicular volume, and blood circulation were documented. RESULTS: Reconvalescence in group A was slower than in group B. In group A, the postoperative values of the visual scales for pain development were higher; inability to work was 7.3 days longer; urologic disorders were worse; activities of everyday life were more reduced; and SF-36 data showed a significant reduction of physical problems ( p < 0.05). CONCLUSIONS: The polypropylene mesh variant seems to be more compatible with the human organism than conventional mesh. Not only the material, but also the structure seems to influence the comfort of the mesh.

[Urological symptoms after laparoscopic hernia repair. Reduction with a variant of polypropylene mesh]. / Urologische Symptome nach laparoskopischer Leistenhernienversorgung. Reduktion durch Polypropylennetzvariante.

In the context of a prospective, randomized, controlled double-blind study concerning a reduction of postoperative, urogenital affections after laparoscopic hernia repair using a polypropylene mesh, laparoscopic polypropylene implantation was performed in 40 male patients. Twenty patients received a heavyweight, rigid polypropylene mesh (group A) and the remainder a heavyweight, but softer polypropylene mesh (group B). Questionnaires were used to assess the severity of pain, impairment of sexual life, appearance of urogenital affections, and general condition. On the 3rd postoperative day, testicle blood circulation and testicle volumes were documented by ultrasound, and a congestion of the plexus pampiniformis was excluded by ultrasound with 5 MHz. Starting in the 1st postoperative week, a prevalence of affections such as testicular sensitivity to touch, pain upon ejaculation, and a pulling sensation during urination became apparent in group A. In the 12th postoperative week, 20% in group A still described testicular sensitivity to touch and 10% pain upon ejaculation and a pulling sensation during urination but only 5% in group B. It is essential to reduce urogenital affections after laparoscopic hernia repair by strict indications and appropriately adapted polypropylene meshes.

Perioperative levels of atrial natriuretic peptide and troponin-T in patients with uncomplicated coronary artery surgery.

HYPOTHESIS: increased ANP levels after uncomplicated coronary artery surgery (CAS) indicate functional reduction. EXPERIMENTAL DESIGN: prospective, randomized. Preoperative upto the 12 week postoperative. SETTING: Thoracic and Cardiovascular Surgery, University of Düsseldorf. PATIENTS: 15 patients (mean age: 58+/-6.1 years; 13 months, 2 weeks; no myocardial infarction, no congestive heart failure) with 3 vessel disease. INTERVENTIONS: levels of atrial natriuretic peptide (ANP) (pg/ml; radioimmunoassay), Troponin T (TnT) (ng/ml; ELISA test), haemodynamic parameters, ECG monitoring, m-mode echocardiography (Echo). MEASURES: increase of ANP, TnT levels during extracorporeal circulation (ECC), decrease after operation. RESULTS: Maximal increase of ANP from preoperative 90+/-10 (M+/-SEM) pg/ml (p<0.05) up to intraoperative 380+/-38 pg/ml. Ten days postoperative ANP (26+/-33 pg/ml) still threefold increased compared to preoperative level. Increasement of TnT from preoperative 0.02+/-0.01 ng/ml upto intraoperative 3.44+/-0.47 ng/ml. Ten days postoperative TnT concentration normal (0.13+/-0.11 ng/ml). Correlation of ANP and TnT five min after bypass up to 6 hrs postoperative (p<0.05, r =3.4). Increase of left atrial diameter preoperative 42.2+/-1.1 mm up to 46.8+/-1.2 mm (p<0.05) 10 days postoperative. LVEDD, EF changed from preoperative 51.1+/-0.9 mm, 73+/-2% to 54.5+/-1.2 mm, 65+/-4% 10 days postoperative. CONCLUSIONS: Threefold increase of ANP 10 days postoperative and return of TnT levels to normal under consideration of datas of echo show, that ANP is suitable to indicate the meanterm, functional, myocardial reduction. Increased ANP levels, atrial dilatation and dysfunction are important signs of cardial functional reduction after CAS.

[Determination of the axis after totalendoprosthesis of the knee: functional X-ray photography as golden standard]. / Achsvermessung bei Knie-TEP: Ganzbeinstandaufnahme als Golden Standard.

AIM: To examine the question of which X-ray photography technique should be given preference after implantation of total endoprosthesis of the knee. METHOD: 20 patients (age 74.1; 12 men, 8 women) with total endoprosthesis of the knee (Type Sigma, PFC, Johnson and Johnson) because of primary athrosis. Postoperatively X-ray photographs of the whole leg in standing and 40 x 20 a. p. in a flat position were taken. The angles of the axis were determined and the information analysed. RESULTS: By means of X-ray photography of the whole leg we obtained the following angles: caput-collum-diaphyse 125 +/- 4.3 degrees, femur/basis of the knee 83.2 +/- 2.6 degrees, mechanical femur axis/basis of the knee 89.3 +/- 1.8 degrees, tibia/basis of the talus 89.2 +/- 2.2 degrees. With the 40 x 20 a. p. X-ray photographs we determined the following angles: femur/basis of the knee 82.3 +/- 3.1 degrees, basis of knee/tibia 92.2 +/- 3,6 degrees. Correlating the angles of femur/basis of the knee and basis of the knee/tibia were relations of 0.42 (p < 0.05) and 0.27 (p < 0.05). CONCLUSION: For gaining information about the axis of the leg under functional conditions, one should give preference to X-ray photography of the whole leg.

[Atrial natriuretic peptide as an indicator of mild postoperative cardiac dysfunction after uncomplicated bypass surgery]. / Das atriale natriuretische Peptid als Indikator einer milden postoperativen kardialen Dysfunktion nach unkomplizierter Bypasschirurgie.

Plasma levels of ANP (pg/ml; radioimmunoassay) as a parameter for postischemic dysfunction and levels of Troponin T (TnT) (ng/ml; ELISA test) as a parameter for postischemic cellular damage were determined in 15 patients with coronary artery disease (CAD) (mean age: 58 +/- 6.1 years; 13 m, 2 w; with no history of myocardial infarction and no signs for congestive heart failure) prior to, during and after extracorporal circulation (ECC). Under standardized conditions during the ECC basic parameters concerning the cardial hemodynamic (heart rate (HR); systolic (RRsys, mmHg), diastolic pressure (RR dia, mmHg) central venous pressure (CVP, mmHg); left atrial pressure (LAP, mmHg); left ventricular enddiastolic pressure (LVEDP, mmHg)) and ECG monitoring blood samples were performed: 1) prior to operation (op); 2) prior to CPB; 3) 1 h CPB; 4) 5 min after CPB; 5) 1 h after CPB; 6) 6 h postoperative (postop); 7) 24 h postop; 8) 48 h postop; 9) 10 days postop. Also the left atrial diameter (LAD, mm) and the left ventricular enddiastolic diameter at Q (LVEDD, mm) pre- and postop were documented with m-mode echocardiography (Echo) and ejection fraction (EF, %) was calculated. The bypass operations were performed with intermittent aortic cross-clamping with open venae cavae (CVP: 0-5 mmHg) and moderate hypothermia. For the determination of ANP levels and TnT levels in arterial and venous blood, a double-antibody (AB) radioimmunoassay and an ELISA test were used. Concerning the patients with CAD there was a maximal increase of ANP from preoperative 90 +/- 10 (M +/- SEM) pg/ml (p < 0.05) up to intraoperative 380 +/- 38 pg/ml. Ten days postop, the ANP level was with 262 +/- 33 pg/ml still increased threefold in comparison to the preoperative level. TnT showed an increase from preoperative 0.02 +/- 0.01 ng/ml up to intraoperative 3.44 +/- 0.47 ng/ml. Ten days postop the TnT concentration was at the preoperative level with 0.13 +/- 0.11 ng/ml. Five minutes after bypass up to 48 h postop, ANP and TnT levels were correlated (p < 0.05, r = 3.4). There was an increase of the LAD from preoperative 42.2 +/- 1.1 mm up to 46.8 +/- 1.2 mm (p < 0.05) 10 days postop as determined by m-mode echo. LVEDD and EF changed from preoperative 51.1 +/- 0.9 mm and 73 +/- 2% to 54.5 +/- 1.2 mm and 65 +/- 4% 10 days postop. The significant increase of TnT (172-fold) indicates the cellular, myocardial injury, caused by the operation without signs in ECG recordings and no signs of congestive heart failure. The significantly increased ANP level up to the 10th day postop indicate sa very sensitive prolonged, postischemic dysfunction, which is not compensated 10 days postop.