Collagen- versus gelatine-coated Dacron versus stretch PTFE bifurcation grafts for aortoiliac occlusive disease: long-term results of a prospective,randomized multicenter trial

BACKGROUND: In this prospective randomized multicenter trial, knitted gelatine-coated Dacron, knitted collagen-coated Dacron, and stretch polytetrafluoroethylene (PTFE) aortic bifurcation grafts were compared for their long-term results. METHODS: Between 1991 and 1998, 149 patients undergoing elective revascularization for aortoiliac occlusive disease were prospectively randomized at 3 tertiary referral centers of vascular surgery. The patients received either gelatine-coated Dacron (GEL-D) grafts (n = 52), collagen-coated Dacron (COL-D) grafts (n = 49), or stretch PTFE grafts (n = 48). RESULTS: No intraoperative deaths were recorded. The 30-day mortality was 4%. The mean follow-up time was 97 months. Primary patency rates were 77% for GEL-D, 78% for COL-D, and 79% for PTFE at 8 years. The differences were not different (P >.8). Secondary corrected 8-year patency rates were also not significantly different (P >.5): 91% for GEL-D, 96% for COL-Dm and 90% for PTFE. Five Dacron and 1 PTFE grafts were affected by infections. CONCLUSIONS: Bifurcation grafts for revascularization of aortoiliac occlusive disease using these 3 materials were comparable in terms of primary and secondary patency and long-term complication rates.     

Dacron versus polytetrafluoroethylene for Y-aortic bifurcation grafts: a six-year prospective, randomized trial.

BACKGROUND. A prospective, randomized trial was conducted to compare Dacron with expanded polytetrafluoroethylene (ePTFE) in reconstructive aortoiliac surgery. No comparable trial with a prospective, randomized design with a comparable number of patients or an equal long-term follow-up period can be found in the literature. METHODS. Between 1984 and 1989, 165 patients were randomized for either Dacron or ePTFE on the basis of age, sex, indication for surgery, diabetes, nicotine consumption, runoff, and operative approach. The two groups were well matched for randomization criteria, as well as the incidence of aneurysms. RESULTS. No statistically significant difference was found between the two graft materials in terms of patency rates (corrected 3-year patency rates: Dacron = 95% vs ePTFE = 95%; Breslow, p = 0.83; Mantel-Cox, p = 0.74). Subgroup analysis comparing long-term patency rates of the two graft materials and relating them to poor runoff, good runoff, aneurysms, and arterial occlusive disease also failed to show any significant differences between ePTFE and Dacron. Early graft failure (n = 6; 3.6% of the patient population; p = 0.045) and severe abdominal graft infection (n = 3; 1.8% of the total population) were seen only in ePTFE grafts. However, these did not affect the corrected long-term patency rate of ePTFE grafts. There were five late graft failures with PTFE (3.0%) and four with Dacron (2.4%). CONCLUSIONS. Graft materials currently available for aortoiliac repair were comparable in terms of corrected long-term patency rates. The alleged advantages of PTFE were not confirmed by our data. PTFE grafts were associated with a higher rate of complications, and more redo operations were required to duplicate the results obtained with Dacron.     

Aorto-Y-bifurcation graft: Dacron versus PTFE. Preliminary results of a randomized prospective study

A randomized prospective study comparing PTFE-Y and Dacron-Y-grafts with regard to function rate, morphology, hemodynamic differences along the proximal anastomosis and body of the graft, complications and quality of material was performed. Between March 1983 and February 1987, 112 patients were admitted to the study. Randomization including the criteria of age, sex, indication to operation (chronic occlusive disease, aneurysm) run-off, diabetes, nicotine consumption and operative approach (transperitoneal, retroextraperitoneal) followed the methods of adaptive randomization developed by Pocock and Simon and was well balanced. Function rate and complications as well as morphological alterations showed no significant differences in either group. During a mean observation period of 24 months, Group I yielded a 97% and Group II a 95% function rate (Kaplan-Meier). In all patients but one in each group with limb graft occlusions (n = 5) function was regained by successful thrombectomy and profundaplasty. With respect to Doppler ultrasound differences in flow pattern, in four patients with enlarged proximal side-end anastomosis and adequate--not to large--incision is recommended performing the proximal anastomosis.     

Transabdominal versus retroperitoneal incision for abdominal aortic surgery: Report of a prospective randomized trial

Purpose: The purpose of this study was to perform a randomized, prospective trial that compares the transabdominal with the retroperitoneal approach to the aorta for routine infrarenal aortic reconstruction.Methods: From August 1990 through November 1993, patients undergoing surgery for abdominal aortic aneurysm (AAA) disease or aortoiliac occlusive disease (AIOD) were asked to participate in a randomized trial comparing the transabdominal incision (TAI) to the retroperitoneal incision (RPI) for aortic surgery. One hundred forty-five patients were randomized, with 75 (41 with AAA and 34 with AIOD) in the TAI group and 70 (40 with AAA and 30 with AIOD) in the RPI group. There were no significant differences between the groups in terms of age, sex, postoperative pain control (epidural vs patient-controlled analgesia), or comorbid conditions, except for a higher incidence of chronic obstructive pulmonary disease in the TAI group (21 vs 8 patients).Results: The incidence of intraoperative complications was similar for both groups. After surgery, the incidence of prolonged ileus (p = 0.013) and small bowel obstruction (p = 0.05) was higher in the TAI group. Overall, the RPI group had significantly fewer complications (p < 0.0001). The overall postoperative mortality rate (two deaths) was 1.4%, with both occurring in the TAI group (p = 0.507). The RPI group also had significantly shorter stays in the intensive care unit (p = 0.006), a trend toward shorter hospitalization (p = 0.10), lower total hospital charges (p = 0.019), and lower total hospital costs (p = 0.017). There was no difference in pulmonary complications (p = 0.71). In long-term follow-up (mean 23 months), the RPI group reported more incisional pain (p = 0.056), but no difference was found in incisional hernias or bulges (p = 0.297).Conclusions: We conclude that the RPI approach for abdominal aortic surgery is associated with fewer postoperative complications, shorter stays in the hospital and intensive care unit, and lower cost. There is, however, an increase in long-term incisional pain. Current methods of postoperative pain control seem to decrease the incidence of pulmonary complications. (J VASC SURG 1995;21:174-83.)     

Heparin-bonded Dacron or polytetrafluorethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial

OBJECTIVE: Dacron was largely abandoned for femoropopliteal bypass 30 years ago, because better patency rates were achieved with saphenous vein. Despite the range of potential prosthetics, polytetrafluoroethylne (PTFE) clearly predominates in current femoropopliteal practice. We compared heparin-bonded Dacron (HBD) with PTFE in a randomized multicenter clinical trial. METHOD: Over 28 months, 209 patients (179 above-knee disease, 30 below-knee disease) were randomized to receive HBD (n = 106) or PTFE (n = 103) grafts. Aspirin, 300 mg/d, was started before surgery, and was continued if tolerated. RESULTS: At follow-up for a minimum of 5 years (mean, 76 months; range, 60-89 months), 37 patients (17.7%) had died with patent grafts and 121 (58%) grafts were occluded. Primary patency rate, measured with Kaplan-Meier survival analysis, was 46% (95% confidence interval [CI], 35%-57%) at year 5 for HBD, compared with 35% for PTFE (CI, 25%-45%; P < .055). Long-term patency was achieved in only 4 of 78 interventions performed in 55 thrombosed grafts. Secondary patency rate for HBD was 47% (CI, 36%-58%), and for PTFE was 36% (CI, 26%-46%). Risk factors for arterial disease did not significantly influence prosthetic patency. Major limb amputation was necessary in 9 patients with HBD grafts and 20 patients with PTFE grafts (P < .025). Two amputations in the HBD group and 8 amputations in the PTFE group were in patients undergoing bypass surgery to treat claudication only. Limb salvage rate was 86% (CI, 77%-95%) and 74% (CI, 64%-84%), respectively. CONCLUSIONS: Significantly better patency rates were achieved with HBD than with PTFE at 3 years (P < .044), but the difference was no longer statistically significant at 5 years (P < .055). The incidence of major limb amputation, however, was significantly greater (P < .025) in the PTFE group compared with the HBD group at both 3 and 5 years of follow-up.     

Salmonella infection of a Dacron aortic bifurcation graft.

We report a case of primary salmonella infection of a dacron aortofemoral bypass graft. Local graft excision with extra-anatomic bypass resulted in a successful outcome. Salmonella, whilst the commonest cause of infected abdominal aortic aneurysms, is currently a rare cause of prosthetic graft infection. However, given the increasing prevalence of salmonellosis in the community, we believe this situation will change and surgeons should be alert to this new and dangerous addition to the list of graft pathogens.     

Eversion versus conventional carotid endarterectomy: Late results of a prospective multicenter randomized trial

Objective: The durability of carotid endarterectomy (CEA) may be affected by carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surgery. The optimal CEA technique to reduce perioperative complications and restenosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversion CEA. Previously published perioperative results of this study did not show statistically significant differences in study endpoints between the eversion and standard techniques. Methods: From October 1994 to March 1997, 1353 patients with surgical indications for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdrawal from the assigned treatment occurred in 1.6% of the patients (in 13 assigned to eversion CEA, and in nine assigned to standard CEA). The clinical and duplex scan follow-up examination was 99% complete, and the mean follow-up interval was 33 months (range, 12 to 55 months). The primary outcomes were perioperative and late major stroke and death, carotid restenosis (stenosis ≥ 50% of the lumen diameter detected at duplex scanning), and carotid occlusion. The primary evaluation of study outcomes was conducted on the basis of an intention-to-treat analysis. Results: Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, the restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cerebral angiography that confirmed restenosis in all cases. The cumulative restenosis risk at 4 years was significantly lower in the group that underwent treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P = .01), with an absolute risk reduction of 5.6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment with eversion CEA to prevent one restenosis during the 4-year period. The incidence rate of ipsilateral stroke was 3.3% in the eversion population and 2.2% in the standard group. There were no significant differences in the cumulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standard; P = .2) and death (13.1% for eversion, and 12.7% for standard; P = .7)) in the two groups. Of the 18 variables that were examined for their influence on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P = .0004) and patch CEA (hazard ratio, 0.2; 95% confidence interval, 0.07 to 0.6; P = .002) were negative independent predictors of restenosis with multivariate Cox proportional hazards regression analysis. Conclusion: The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial) showed that eversion CEA is safe, effective, and durable. No statistically significant differences were found in late outcome between the eversion and standard techniques at the available follow-up examination. (J Vasc Surg 2000;31:19-30.)     

Early hydronephrosis following aortic bifurcation graft surgery: a prospective study

The true incidence and natural history of ureteral obstruction following reconstructive vascular surgery have not been determined previously. A series of 101 patients undergoing aortofemoral and aortoiliac reconstructive surgery were studied prospectively to determine the frequency of hydronephrosis in the first postoperative year. Serial real-time ultrasound examinations were performed preoperatively as well as at 1 week, 3 months and 1 year postoperatively. Ninety-three patients completed the study, with a total of 181 kidneys at risk. Hydronephrosis of mild to moderate degree developed in 15 kidneys (8 per cent) in 11 patients (12 per cent). All patients were asymptomatic, and the obstruction resolved spontaneously in 10 of 11 patients, including 9 within 3 months of onset. Only a single case persisted at 1 year. This study confirms that the hydronephrosis that occurs within the first year after aortic bifurcation graft surgery is not uncommon but it is rarely of clinical significance in the asymptomatic patient.     

腹部手术应用短程抗生素预防手术区感染的疗效分析

目的观察抗生素长、短程用药方法预防外科手术区感染的效果.方法全国15家医院进行多中心前瞻性随机对照研究.731例腹部外科手术患者被随机分为2组围手术期短程用药组(术后用药1d)及长程用药组(术后用药3d)预防手术区感染.2组患者在年龄、性别及手术种类等方面均无差异.预防用抗生素为奈替米星或合并使用甲硝唑.结果短程用药组感染率为0.84%(3/358),长程用药组感染率为2.68%(10/373),2组差异无显著性意义(P＞0.05).结论围手术期短程应用抗生素即可有效预防术后手术区感染,从药物经济学和合理用药的角度来说也优于长期用药.     

Early results of a prospective randomized trial of spliced vein versus polytetrafluoroethylene graft with a distal vein cuff for limb-threatening ischemia

OBJECTIVE: Single-piece vein remains the conduit of choice in patients who need bypass grafting for limb salvage. When this option is not available, two of the remaining options are prosthetic bypass graft or several segments of vein spliced together. In this study, we compare spliced vein bypass grafting versus polytetrafluoroethylene grafting with a distal vein cuff in patients with limb-threatening ischemia. METHODS: Between 1996 and 2000, 39 bypass grafting procedures in 36 patients were performed for limb-threatening ischemia. These procedures were prospectively randomized to either spliced vein bypass grafting (spliced group, 19 bypass grafts) or polytetrafluoroethylene grafting with a distal vein cuff (cuff group, 20 bypass grafts). All the patients in the cuff group underwent anticoagulation therapy with warfarin sodium after surgery. The inclusion criteria included: no single-piece vein option for bypass grafting, adequate vein for splice, no composite sequential option, and limb-threatening ischemia. The demographics were similar between the two groups. RESULTS: The primary patency rate at 2 years was 44% and 49% for the spliced and cuff groups, respectively. In the spliced group, seven of 19 bypass grafts underwent revision in the follow-up period, and two of 20 cuffed bypass grafts were successfully revised. The secondary patency rate was 87% and 59% (P <.05), with limb salvage rates of 94% and 85% for spliced and cuff groups, respectively. Four patients in the spliced vein group needed reoperation for wound complications related to vein harvest. One polytetrafluoroethylene graft needed removal for infection. Two early mortalities occurred in the spliced group, one from myocardial infarction and one from stroke. The overall survival rate at 2 years between the two groups was 67% and 100% for the spliced and cuff groups, respectively (P <.05). CONCLUSION: Although this is a preliminary report, it appears that both spliced vein bypass grafting and polytetrafluoroethylene bypass grafting with a distal vein cuff produce acceptable limb salvage rates. The secondary patency rate for spliced vein is better, but these bypass grafts more often need revision or reoperation for wound complications.     

The safety of immediate extubation after abdominal aortic surgery: a prospective, randomized trial.

We performed this study to assess the safety of immediate extubation after elective abdominal aortic aneurysm surgery. Consecutive patients were prospectively randomized into two groups after surgery: Group 1 (n = 29) immediate extubation; and Group 2 (n = 21) delayed (at least 4 h) extubation. All patients were assessed by a senior anesthesiologist or intensivist before extubation. The following data were collected: preoperative-demographics, presence of comorbid disease, body mass index, hemoglobin level, heart rate, and blood pressure; intraoperative-duration of surgery and cross-clamping, blood loss, amount of crystalloids, colloids, and blood transfused, temperature at end of procedure, urine output, and complications; and postoperative-time to extubation, scores on the Acute Physiology and Chronic Health Evaluation-II and Therapeutic Intervention Scoring System, total fentanyl dose, and complications. Outcome variables were length of intensive care unit and hospital stay and 28-day mortality. The results showed no significant differences in preoperative or intraoperative variables between the groups, apart from a longer duration of surgery in Group 1 (P = 0.045). Group 2 patients had a significantly higher Therapeutic Intervention Scoring System score (P = 0.04) and required a significantly larger dose of fentanyl (P < 0.001). One patient in Group 2 required reintubation after a cerebrovascular accident. The overall mortality rate was 4% (2 patients in Group 2). There were no significant differences in any of the outcome variables. We conclude that immediate extubation can safely be performed after elective abdominal aortic aneurysm surgery. IMPLICATIONS: In this prospective randomized study, we compared the outcome of patients undergoing elective aortic abdominal surgery who either were extubated immediately after surgery or after 4 h of stabilization in the intensive care unit. No significant differences were found in the length of intensive care unit or hospital stay, or 28-day mortality between the 2 groups.     

Heparin-bonded Dacron or polytetrafluoroethylene for femoropopliteal bypass grafting: a multicenter trial

BACKGROUND: Dacron (polyester fiber) was largely abandoned for femoropopliteal bypass grafts 30 years ago because saphenous vein achieved better patencies. However, in patients taking aspirin, patency in above-knee femoropopliteal bypass grafts has recently been shown to be equivalent to that with saphenous vein. We compared heparin-bonded Dacron (HBD) and polytetrafluoroethylene (PTFE) in a randomized multicenter trial including below-knee popliteal or tibioperoneal trunk bypass graft where the long saphenous vein was absent or inadequate. METHODS: Over 28 months, 209 patients undergoing femoropopliteal bypass grafts (180 above-knee, 29 below-knee) were randomized to HBD (n = 106) or PTFE (n = 103). Each patient was given aspirin (300 mg/d) before surgery, and this continued unless the patient had intolerance to the aspirin. RESULTS: The mean follow-up was 42 months (range, 28-55). Fifteen (7.1%) patients died with patent grafts, and three (1.4%) infected grafts were removed. Patency (measured with Kaplan-Meier survival analysis) at 1, 2, and 3 years for HBD was 70%, 63%, and 55% compared with 56%, 46%, and 42%, respectively, for PTFE (P =.044). A total of 67 secondary interventions were performed on 48 thrombosed grafts; long-term patency was achieved in only three. Risk factors for arterial disease did not significantly influence patency. Amputations have been performed in 23 patients, six after HBD and 17 after PTFE bypass grafts (P =.015). CONCLUSIONS: HBD achieved better patency than PTFE, which carried a high risk of subsequent amputation.     

Ruptured abdominal aortic aneurysm: Six-year follow-up results of a multicenter prospective study

Purpose: On the basis of a prospective analysis of 147 patients undergoing surgery for ruptured abdominal aortic aneurysm (AAA) and recorded in the Canadian Society for Vascular Surgery Aneurysm Registry, this study defines the early and 6-year actuarial survival rates and determines the predictive variables that are associated with survival.Methods: Ongoing follow-up of a cohort of patients was current at the time of analysis. To identify the preoperative, intraoperative, and postoperative variables that were associated with survival, statistical methods included chi-squared analysis, logistic regression analysis, Kaplan-Meier analysis, and Cox regression analysis.Results: The survival rate was 48.6% at 1 month, 34.7% ± 4.2% at 3 years, and 22.0% ± 4.0% at 6 years. When preoperative and intraoperative variables were considered and logistic regression analysis was used, the highest probability of early in-hospital survival was associated with preoperative creatinine levels of 1.3 mg/dl or less, intraoperative urine output of 200 ml or greater, and infrarenal clamp site. The highest probability of late survival, as calculated by the Cox proportional hazards method, was predicted by the patient's age and total urine output during the procedure. When all variables, including postoperative complications, were considered, late survival was highest if intraoperative urine output was 200 ml or greater and respiratory failure and myocardial infarction did not occur. For those patients with ruptured AAA who survived operation (i.e., greater than 1 month), the long-term survival rate was significantly lower than a comparable group undergoing repair of nonruptured AAA.Conclusions: Patients who survive repair of a ruptured AAA have a lower late survival rate than patients undergoing elective repair. When a patient is evaluated before operation, no combination of preoperative variables could identify those patients with little or no chance of survival; hence, the decision to repair a ruptured AAA should be made on clinical grounds. However, after surgery (when information on intraoperative and postoperative variables is also available), the results of this study provide a basis for the surgeon to use these prognostic variables to assist clinical judgment and guide discussions on prognosis with the family and to identify those patients who have such a low chance of early and late survival that further aggressive treatment may be futile. (J VASC SURG 1994;19:888-900.)     

Clinical and CT evaluation of a new stretch polytetrafluoroethylene aortic graft

A new stretch polytetrafluoroethylene (PTFE) aortic graft became available for clinical use in early 1991. We prospectively evaluated our first 107 stretch aortic PTFE grafts by means of serial CT imaging and compared them with a cohort of concurrently placed Dacron grafts. Stretch PTFE requires no preclotting and is claimed to resist long-term dilation and conform well to anastomoses. Consecutive patients undergoing placement of stretch PTFE grafts were seen at least yearly. Within the first 2 years after implantation, contrast-enhanced CT scans of the abdomen and pelvis were obtained. Caliper measurements were made of the native arteries and the body and any limbs of the aortic grafts. Graft elongation was assessed by noting distortions from the normally circular or minimally ovoid configuration of the grafts on transverse CT images. Indications for grafting were elective repair of abdominal aortic aneurysm in 60 patients, aortoiliac occlusive disease in 31, both aneurysm and occlusive disease in eight, and ruptured abdominal aortic aneurysm in eight. The overall operative mortality rate was 6.5%. There were two early postoperative graft limb thromboses resulting from hypercoagulable states, and there was one graft infection. Mean follow-up was 14.1 months (range 1 to 34 months). CT scans were obtained from 61 patients with stretch PTFE grafts and 10 with concomitantly placed Dacron grafts. Ten patients had two or more postoperative CT scans. Primary stretch PTFE patency was 98% and secondary patency, 100%. There was significantly less dilation of both the graft body and limbs in the stretch PTFE group (body mean 16.5%, range 6.3% to 28.1%; limb mean 19.3%, range 10% to 43%) compared to the Dacron group (body mean 33%, range 22% to 78%; limb mean 62%, range 12.5% to 88.9%) (p <0.01,unpaired t test). Those patients with serial scans showed no dilation beyond the first scan. No evidence of elongation, kinking, or pseudoaneurysm was noted in any of the stretch PTFE grafts. For a moderate follow-up interval, the new stretch PTFE grafts have performed exceptionally well. There appears to be significantly less dilation with these grafts as compared with Dacron grafts over the same time interval, and there has been no evidence of graft elongation to date.Presented at the Thirteenth Annual Meeting of the Southern California Vascular Surgical Society, Coronado, Calif., September 16–18, 1994.We thank Drs. Charles Pratt and Margaret Montana for their assistance with data collection and Dr. Kenneth McIntyre for allowing us to use some of his patients for this project.     

Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial

BACKGROUND: The prevalence of venous leg ulcers is as high as 1% to 1.5%, and the total costs of this disease are 1% of the total annual health care budget in Western European countries. Treatment modalities are conservative or surgical. Subfascial endoscopic perforating vein surgery (SEPS) combined with superficial vein ligation is performed in many centers to address vein incompetence in patients with chronic venous leg ulcers. Several reports describe good healing and low recurrence rates, although a randomized trial to compare surgical treatment including SEPS and treatment of the superficial venous system to conservative modalities has never been performed. Therefore, a prospective, randomized, multicenter trial was conducted to study whether ambulatory compression therapy with venous surgery is a better treatment than just ambulatory compression therapy in venous leg ulcer patients. METHODS: Patients with an active (open) venous leg ulcer (CEAP C6) qualified for the study. The study consisted of two treatment groups. All patients were treated by standardized ambulatory compression therapy, and half of the patients received SEPS. Concomitant superficial venous incompetence was also treated in the second group. For allocation to both treatment groups, each patient was assigned by a computer program at the randomization center. The primary goal of the study was to compare the ulcer-free period during follow-up in both study groups. Secondary end points were ulcer healing and recurrence rates. RESULTS: From April 1997 until January 2001, 200 ulcerated legs (170 patients) were included in the study in 12 centers in The Netherlands. A total of 97 ulcers were allocated to the surgical group and 103 to the conservative group. Patient characteristics were similar in the two treatment groups at baseline, with the exception of a higher proportion in the conservative group of diabetes mellitus. Healing rates were 83% in the surgical group and 73% in the conservative group (not significant; median time to healing, 27 months). Recurrence rates were the same in both treatment groups (22% surgical vs 23% conservative). During follow-up of a mean of 29 months (median, 27 months) in the surgical group and 26 months (median, 24 months) in the conservative group, we found that in the surgical group, the ulcer-free rate was 72%, whereas in the conservative group this rate was 53% (P = .11; Mann-Whitney test). Patients with recurrent ulceration or medially located ulcers in the surgical group had a longer ulcer-free period than those treated in the conservative group (P = .02 for both). A first-time ulcer and one of the centers also had a positive effect on the ulcer-free period during follow-up (P < .001 and P = .02), independent of the treatment group. Deep vein incompetence did not affect the ulcer-free period. CONCLUSIONS: In conclusion, we suggest that patients with medial and/or recurrent ulceration should receive surgery combined with ambulatory compression therapy. A dedicated center should provide care for those patients.     

Recurrence and complications after laparoscopic versus open inguinal hernia repair: results of a prospective randomized multicenter trial

BACKGROUND: The aim of this prospective randomized multicenter trial was to evaluate the recurrence rates and complications of open versus laparoscopic repairs of inguinal hernias. METHODS: Patients with primary unilateral inguinal hernias were randomized to Shouldice repair, Bassini operation, tension-free hernioplasty (Lichtenstein repair), laparoscopic transabdominal extraperitoneal hernioplasty (TEP), or laparoscopic transabdominal preperitoneal hernioplasty (TAPP). The primary outcome parameter was the rate of recurrence at 3 years. The secondary outcome was the rate of intraoperative, perioperative, and long-term complications. Follow-up comprised of clinical examination after 1, 2, and 3 years. RESULTS: Three hundred and sixty-five patients were randomly assigned to one of the five procedures. The intention-to-treat analysis showed that the cumulative 3-year recurrence rate was 3.4% in the Bassini group, 4.7% in the Shouldice group, 0% in the Lichtenstein group, 4.7% in the TAPP group, and 5.9% in the TEP group (p = 0.48). Comparing open (Bassini, Shouldice, Lichtenstein) versus laparoscopic (TAPP, TEP) techniques (p = 0.29) and comparing the use of mesh prostheses (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) (p = 0.74) showed no significance in the rate of recurrence. The rates of intraoperative (p = 0.15), perioperative (p = 0.09), and long-term complications (p = 0.13) were without significance between the five groups. Comparing mesh techniques (Lichtenstein, TAPP, TEP) versus suturing techniques (Bassini, Shouldice) showed no significance in the rate of complications. The per-protocol analysis for the comparison of mesh (Lichtenstein, TAPP, TEP) versus suturing (Bassini, Shouldice) techniques revealed that recurrences (p = 0.74), intraoperative (p = 0.64), perioperative (p = 0.27), and long-term complications (p = 0.91) were evenly distributed. CONCLUSIONS: In this multicenter study, no significant difference in the recurrence rate and complications between laparoscopic and open methods of hernia repair was revealed.