Same Site Recurrence is More Frequent After Endovenous Laser Ablation Compared with High Ligation and Stripping of the Great Saphenous Vein: 5 year Results of a Randomized Clinical Trial (RELACS Study).

OBJECTIVE: To compare the long-term clinical efficacy of endovenous laser ablation (EVLA) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) incompetence. DESIGN: Investigator initiated two centre randomized controlled trial with 5 year follow up. MATERIALS AND METHODS: Interventions were performed on ambulatory and hospitalized patients at two vein centres, a university dermatology department (EVLA) and a specialized vein clinic (HLS). Four hundred patients suffering from GSV incompetence were assigned to EVLA or HLS of the GSV. One hundred and eighty five and 161 patients (=limbs), respectively, were treated per protocol. Main outcome measures were clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), Duplex detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), quality of life (Chronic Venous Insufficiency Questionnaire 2), side effects, and patient satisfaction 5 years after treatment. RESULTS: Two hundred and eighty one legs (81% of the study population) were evaluated with a median follow up of 60.4 (EVLA) and 60.7 months (HLS). Overall, REVAS was similarly observed in both groups: 45% (EVLA) and 54% (HLS), p = .152. Patients of the EVLA group showed significantly more clinical recurrences in the operated region (REVAS: same site): 18% vs. 5%, p = .002. In contrast, more different site recurrences were observed in the HLS group: 50% vs. 31%, p = .002. Duplex detected saphenofemoral refluxes occurred more frequently after EVLA: 28% vs. 5%, p < .001. Both treatments improved disease severity and quality of life without any difference. CONCLUSIONS: EVLA and HLS are comparably effective concerning overall REVAS, improvement of disease severity, and quality of life. In terms of same site clinical recurrence and saphenofemoral refluxes, HLS is superior to EVLA 5 years after treatment. CLINICAL TRIAL REGISTRATION: ISRCTN18322872.

Residual stumps associated with inguinal varicose vein recurrences: a multicenter study.

PURPOSE: It is unclear whether a residual sapheno-femoral stump left in place after stripping of the great saphenous vein can contribute to the formation of late inguinal varicose vein recurrence. In order to obtain information about the time course of recurrence development, patients with histologically proven residual stumps were recruited and asked about the interval between the initial operation and the first clinical signs of varicose vein recurrence. METHODS: A multi-centre study involving 7 centres was conducted amongst patients undergoing redo-surgery for inguinal varicose vein recurrences. The sapheno-femoral stumps resected during the redo-surgery were classified histologically. Patients with a proven long residual sapheno-femoral stump were asked to describe the first signs of varicose vein recurrence with the help of a standardised questionnaire. From these data the symptom-free interval, consisting of the time frame between the initial operation and the first signs of recurrence, was determined. RESULTS: In 279 legs of 251 patients a long residual sapheno-femoral stump was present. Most patients had experienced a symptom-free interval after the initial operation with a mean duration of 7.4 S.D. 5.5 years. Recurrent varicose veins became apparent after a mean time interval of 6.3 S.D. 5.3 years and congestion symptoms occurred after a mean interval of 8.5 S.D. 5.7 years. CONCLUSIONS: In patients with symptomatic groin recurrences, a long residual sapheno-femoral stump was found in about two thirds of cases. The first clinical signs of varicose vein recurrence can be expected 7-8 years after the initial treatment at the earliest. Long term follow up is required reliably to asses the outcome of treatment for varicose veins.

Reduction of neoreflux after correctly performed ligation of the saphenofemoral junction. A randomized trial.

BACKGROUND: Neoreflux at the sapheno-femoral junction (SFJ) is an important cause of recurrent great saphenous varicose veins. This study compares four surgical methods of ligating the SFJ with the aim to reduce the rate of neoreflux. METHOD: In a prospective study, 379 patients (500 SFJ ligations) were randomised to one of four surgical procedures at the SFJ (125 groins each). In group A (control group) the SFJ was ligated in standard fashion with Vicryl (absorbable ligature); in group B, after Vicryl ligation continuous Prolene (non-absorbable) was sutured over the stump endothelium to prevent any contact with surrounding tissue; in group C. SFJ ligation was done with Ethibond (non-absorbable); in group D Ethibond ligation was followed by Prolene oversewing. The final study group included 114 patients (152 groins) who were all known to be free from recurrent groin reflux 3 months postoperatively and had colour duplex venous imaging 2 years after operation. RESULTS: Duplex imaging identified neoreflux at the SFJ in 10 out of 114 groins after 2 years (7%). There were differences in the rates between the four groups: Group A 3/31 (10%), Group B 0/32, Group C 5/44 (11%) and Group D 2/45 (4%). Neoreflux was significantly reduced in the two groups with endothelial closure (B and D): 2/70 (3%) versus 8/75 (11%, p<0.025). CONCLUSION: Recurrent reflux in the groin was reduced by over sewing the ligated SFJ in patients having varicose vein surgery. This adds weight to the theory of neovascularisation as a cause of recurrent veins and offers a means to reduce clinical recurrence rates.

[Major vascular and neural complications in varicose vein surgery. Prospective documentation of complication rate in surgery of the V. saphena magna and V. saphena parva]. / Major-Komplikationen am Gefäss- und Nervensystem in der Varicenchirurgie. Prospektive Dokumentation des Operationsrisikos bei der V. saphena magna- und V. saphena parva-Operation.

The complication rate in varicose vein surgery has not been viewed separately for the sapheno-femoral and the saphenopopliteal junction. From 1.10.1988 to 31.12.99 we prospectively registered the major vascular and neural complication rate. A total of 31,838 ligations of the saphenofemoral junction and 6,152 ligations of the saphenopopliteal junction were performed. There were seven major vascular injuries (0.017%) and three major neural injuries (0.0074%). The specific risk at the saphenofemoral junction amounts to: major venous injury n = 4 (0.013%) without development of a postthrombotic syndrome (PTS); no arterial injury and no major neural injury. At the saphenopopliteal junction we found three major venous injuries (0.049%) with development of PTS in all cases. There were three major neural injuries (0.049%) with complete regeneration in two cases and one permanent paresis of digit V. Since operations on the saphenopopliteal junction show a higher risk of major vascular und major neural injury, flush ligation of the saphenopopliteal junction should not be forced in every case.

[Is there justification for varicose vein surgery with local anesthesia in successive procedures? Prospective study of 5,000 crossectomy/stripping operations]. / Gibt es eine Berechtigung für eine Varizenchirurgie in Lokalanästhesie mit sukzessiver Verfahrensweise? Prospektive Untersuchung an 5,000 Crossektomie/Stripping-Operationen.

UNLABELLED: In a prospective study we examined the complications of 5,000 operations (n = 876 as outpatient; ligations of the SFJ/SPJ +/- stripping or recurrence operation of the SFJ/SPJ), that were carried out under local anaesthesia in a successive procedure. We registered only the in-hospital complications or those occurring during the first postoperative week of outpatient procedure: Mortality, deep venous thrombosis, pulmonary embolism, major vascular injuries, major nerval injuries, anaesthesia complications. The proof and/or exclusion of complications were done by clinical investigations with the parameters: Mortality, vascular and/or nerval injuries, anaesthesia complications as well as pulmonary embolism. With the parameter deep venous thrombosis n = 2,495 operations were examined by color duplex scan in the region of the sapheno-femoral (popliteal) junction before patients were discharged from hospital/ambulatory therapy. In the other patients the diagnosis was done according to clinical parameters. RESULTS: In the investigation period two complications occurred at the nerval-system after difficult ligation of the SPJ: a) Paresis concerning mainly the peroneal branch of the N. ischiadicus with regeneration after nine months. b) Lesion of the N. tibialis with paresis of the M. abductor digiti minimi that was unchanged after seven months. CONCLUSION: Varicose vein surgery under local anaesthesia as a successive procedure represents a very safe treatment option. A comparison with literature data from prospective or retrospective studies is not possible, because of missing studies and/or unclear information or definition problems. It would be desirable if such studies could be performed.

[Prospective study of avoiding neoangiogenesis after great saphenous vein crossectomy. Initial results]. / Prospektive Studie zur Verhinderung der Neoangiogenese nach Magna-Crossektomie. Erste Ergebnisse.

A meticulous dissection of the sapheno-femoral junction (SFJ) at the time of primary surgery is regarded as best protection against the development of recurrences from this area. However, despite correct ligation of the junction recurrences may occur. In a prospective randomised trial, which has been started in 1998, we want to find out, whether this regrowth might be inhibited by the use of different ligation technics of the SFJ: Group 1: Ligation of the SFJ with resorbable Vicryl Group 2: Ligation with Vicryl and continuous non-resorbable stitching over (Prolene) the saphenous stump which precludes contact between free stump endothelium and the surrounding subcutaneous tissue Group 3: Non-resorbable ligation of the SFJ (Ethibond) Group 4: Ethibond ligation with Prolene stitching over the saphenous stump. The first follow-up examinations, which have been done by color-dupley-scan are presented. In each group about n = 100 groins could be examined. We found slight inguinal insufficiency due to a small branch of the femoral vein in group one: n = 10; group two: n = 6; group three: n = 3; group four: n = 1. Our hypothesis that the use of the suture material or the free lying stump endothelium might be influencing the development of the neovascularisation, seems to be supported by these results. We found the lowest rate of postoperative inguinal refluxes in the Ethibond-Prolene group, where the contact between free stump endothelium and the surrounding subcutaneous tissue is precluded. However, definite reliable data will be presented not before the third follow-up (24 months after the operation).

[Peridural anesthesia and analgesia results in general surgery]. / Peridurale Anaesthesie- und Analgesieverfahren in der Allgemeinchirurgie.

Anesthesia for major general surgery should involve the use of anesthetic techniques that might reduce the risk of intraoperative and postoperative complications. The combination of intraoperative epidural anesthesia with local anesthetics (EPA) and the use of epidural opiates for postoperative pain relief shows advantages over the application of pure general anesthesia and over postoperative systemic analgesia. Epidural opiates lead to better quality analgesia with a quicker onset and longer duration than systemical analgesics. The spirographic parameters of ventilatory function PF, FVC, FEV [1], paO2, and paCO2 decreased significantly (p less than 0.05) compared with preoperative values when systemic analgesia was performed. After epidural opiates no significant decrease could be seen. Intraoperative use of EPA has the advantages of better hemodynamic conditions and a blockade of the endocrine-metabolic response to surgery. Postoperative peridural opiates block the endocrine response as well: the serum levels of ADH and cortisol are lower than under systemic analgesia.

[Variations in vasopressin (ADH)-levels during NLA combined with epidural fentanyl-analgesia (author's transl)]. / Plasma-ADH-Spiegel unter kombinierter Neurolept-Analgesie/Peridurale Opiat-Analgesie.

10 patients scheduled for thoracic, abdominal or vascular surgery received anaesthesia as a combination of neuroleptanalgesia plus epidural opiate-analgesia. Antidiuretic hormone levels (ADH), serum-electrolytes (Na+, K+) and plasma osmolality have been investigated preoperatively (twice), intraoperatively (six times), during the first postoperative day (three times) and for five days postoperatively (once a day). There was a significant increase in ADH in all patients intra- and postoperatively, whereas serum-electrolytes and plasma-osmolality stayed within normal range. Maximum ADH-values were measured during the intraoperative period, postoperatively ADH-levels reached the normal range after 5 days. This increase in plasma-ADH-levels was not accompanied by typical haemodynamic changes. From the aspect of metabolic endocrine response to surgery, our results indicate no advantage of the combination of neurolept-analgesia plus epidural opiate-analgesia for the intraoperative period.

[Plasma-antidiuretic hormone level as indicator of postoperative stress (part II) (author's transl)]. / Plasma-ADH-Spiegel als perioperativer Stressparameter. 2. Mitteilung.

For a period of five days serum levels of antidiuretic hormone (ADH) have been investigated postoperatively in a group of 20 patients with upper abdominal surgery. In addition serum electrolytes (Na+, K+) and plasma osmolality have been controlled regularly. Patients in group A (n = 10) received Fentanyl epidurally (0.1-0.2 mg diluted with 0.9% saline solution) for treatment of postoperative pain, whereas in group B (n = 10) systemic opiate therapy was performed by intramuscular application of piritramide (Dipidolor, 15-25 mg). There was a significant increase in ADH in all patients, whereas serum electrolytes (Na+, K+) and plasma osmolality stayed within normal range. ADH-levels in group A (epidural opiate), however, were significantly lower than mean values in group B (systemic opiate application). The postoperative increase in ADH is interpreted as a reaction to stress and trauma, being less pronounced, when epidural opiate therapy is performed for postoperative pain treatment.