Long-term Results of a Randomized Double-blinded Prospective Trial of a Lightweight (Ultrapro) Versus a Heavyweight Mesh (Prolene) in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TULP-trial).

OBJECTIVE: The aim of the randomized clinical trial was to compare the 2 years of clinical outcomes of a lightweight (Ultrapro) vs a heavyweight (Prolene) mesh for laparoscopic total extraperitoneal (TEP) inguinal hernia repair. BACKGROUND: Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about a similar benefit for laparoscopic repair is ongoing, but concerns exist about higher recurrence rates. METHODS: Between March 2010 and October 2012, male patients who presented with a primary, reducible unilateral inguinal hernia who underwent day-case TEP repair were eligible. Outcome parameters included chronic pain, recurrence, foreign body feeling, and quality of life scores. RESULTS: During the study period, 950 patients were included. One year postoperatively the presence of relevant pain (Numeric Rating Score 4-10) was significantly higher in the lightweight mesh group (2.9%) compared with the heavyweight mesh group (0.7%) (P = 0.01), and after 2 years this difference remained significant (P = 0.03). There were 4 (0.8%) recurrent hernias in the heavyweight mesh group and 13 (2.7%) in the lightweight group (P = 0.03). No differences in foreign body feeling or quality of life scores were detected. CONCLUSIONS: In TEP hernia surgery, there was no benefit of lightweight over heavyweight meshes observed 2 years postoperatively.

Complications after plate fixation and elastic stable intramedullary nailing of dislocated midshaft clavicle fractures: a retrospective comparison.

PURPOSE: The incidence of operative treatment of dislocated midshaft clavicle fractures (DMCF) is rising due to unsatisfactory results after non-operative treatment. Knowledge of complications is important for selection of the surgical technique and preoperative patient counselling. The aim of this study is to compare complications after plate fixation and elastic stable intramedullary nailing (ESIN) with a titanium elastic nail (TEN) for DMCF. METHODS: A retrospective analysis of our surgical database was performed. From January 2005 to January 2010, 90 patients with DMCF were treated with plate fixation or ESIN. Complications were evaluated in both treatment groups and subsequently compared. RESULTS: Seven implant failures occurred in six patients (14 %) of the plate group and one implant failure (2.1 %) was seen in the ESIN group (p = 0.051). Major revision surgery was performed in five cases in the plate group (11.6 %) and in one case (2.1 %) in the ESIN group (p = 0.100). Three refractures (7.0 %) were observed in the plate group after removal of the implant against none in the ESIN group (p = 0.105). Six minor revisions (13 %) were reported in the ESIN group and none were reported in the plate group (p = 0.027). CONCLUSIONS: Compared to other studies we report higher rates of refracture (7.0 %), major revision surgery (11.6 %) and implant failure (14.0 %) after plate fixation. The frequency of implant failures differed almost significantly for patients treated with plate fixation compared to ESIN. Furthermore, a tendency towards refracture after implant removal and major revision surgery after plate fixation was observed.

Acute Achilles tendon rupture: minimally invasive surgery versus nonoperative treatment with immediate full weightbearing--a randomized controlled trial.

BACKGROUND: Surgical repair of acute Achilles tendon ruptures is considered superior to nonoperative treatment, but complications other than rerupture range up to 34%. Nonoperative treatment by functional bracing seems a promising alternative. HYPOTHESIS: Nonoperative treatment of acute Achilles tendon rupture with functional bracing reduces the number of complications compared with surgical treatment with a minimally invasive technique. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 2. METHOD: Using concealed random allocation, 83 patients with acute Achilles tendon rupture were assigned to nonoperative treatment by functional bracing or minimally invasive surgical treatment followed by tape bandage. Patients were allowed full weightbearing, and follow-up was 1 year. RESULTS: Complications risk other than rerupture by intention-to-treat basis was 9 in 42 patients (21%) for surgical treatment and 15 in 41 patients (36%) for nonoperative treatment (risk ratio, 0.59; 95% confidence interval, 0.29-1.19). Reruptures risk was 5 in 41 patients after nonoperative treatment and 3 in 42 patients for surgical treatment (risk ratio, 0.59; 95% confidence interval, 0.15-2.29). The mean time to work was 59 days (SD, 82) after surgical treatment and 108 days (SD, 115) after nonoperative treatment (difference, 49 days; 95% confidence interval, 4-94; P < .05). The difference between treatments for return to sports (risk ratio, 0.55; 95% confidence interval, 0.23-1.29), pain, and treatment satisfaction did not reach statistical significance. CONCLUSION: There appears to be a clinically important difference in the risk of complications between minimally invasive surgical treatment and nonoperative treatment for acute Achilles tendon ruptures, but this was not statistically significant.