Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur

Introduction and hypothesis  

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.     

One-year follow-up after incisional hernia treatment: results of a prospective randomized study

Background  

The incidence of incisional hernia after midline laparotomies ranges from 10 to 20%. The recurrence rate after this hernia surgery varies from 25 to 52% using autogenous tissue. The use of prosthetic meshes can decrease the postoperative hernia recurrence by up to 10%. The aim of this prospective randomized clinical study was to analyze and compare the results of three different incisional hernia surgical techniques.     

TVT versus TOT, 2-year prospective randomized study

Purpose

To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT.

Methods

Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare^®) or TOT (Aris^®). All women were seen 1 week, 3, 6, 12, 18, and 24 months.

Results

Seventy-one women completed 2-year follow-up. Median age was 47 (range 33–60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m². POP of any degree was seen in 50 % (35 women). At 1 year, pad test–negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT.

Conclusions

Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.     

A randomized trial comparing TVT with TVT-O: 12-month results

The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.     

Long-term results of a randomized prospective study comparing medical and surgical treatment of Barrett's esophagus

OBJECTIVE: To compare the results of medical treatment and antireflux surgery in patients with Barrett's esophagus (BE). SUMMARY BACKGROUND DATA: The treatment of choice in BE is still controversial. Some clinical studies suggest that surgery could be more effective than medical treatment in preventing BE from progressing to dysplasia and adenocarcinoma. However, data from prospective comparative studies are necessary to answer this question. METHODS: One hundred one patients were included in a randomized prospective study, 43 with medical treatment and 58 with antireflux surgery. All patients underwent clinical, endoscopic, and histologic assessment. Functional studies were performed in all the operated patients and in a subgroup of patients receiving medical treatment. The median follow-up was 5 years (range 1-18) in the medical treatment group and 6 years (range 1-18) in the surgical treatment group. RESULTS: Satisfactory clinical results (excellent to good) were achieved in 39 of the 43 patients (91%) undergoing medical treatment and in 53 of the 58 patients (91%) following antireflux surgery. The persistence of added inflammatory lesions was significantly higher in the medical treatment group. The metaplastic segment did not disappear in any case. Postoperative functional studies showed a significant decrease in the median percentage of total time with pH below 4, although 9 of the 58 patients (15%) showed pathologic rates of acid reflux. High-grade dysplasia appeared in 2 of the 43 patients (5%) in the medical treatment group and in 2 of the 58 patients (3%) in the surgical treatment group. In the latter, both patients presented with clinical and pH-metric recurrence. There was no case of malignancy after successful antireflux surgery. CONCLUSIONS: These results show that there are no differences between the two types of treatment with respect to preventing BE from progressing to dysplasia and adenocarcinoma. However, successful antireflux surgery proved to be more efficient than medical treatment in this sense, perhaps because it completely controls acid and biliopancreatic reflux to the esophagus.     

Laparoscopic gastric banding: a prospective, randomized study comparing the Lapband and the SAGB: early results

OBJECTIVE: The objective of this study was to evaluate the results of laparoscopic gastric banding using 2 different bands (the Lapband [Bioenterics, Carpinteria, CA] and the SAGB [Swedish Adjustable Gastric Band; Obtech Medical, 6310 Zug, Switzerland]) in terms of weight loss and correction of comorbidities, short-and long-term complications, and improvement of quality of life in morbidly obese patients SUMMARY BACKGROUND DATA: During the past 10 years, gastric banding has become 1 of the most common bariatric procedures, at least in Europe and Australia. Weight loss can be excellent, but it is not sufficient in a significant proportion of patients, and a number of long-term complications can develop. We hypothesized that the type of band could be of importance in the outcome. METHODS: One hundred eighty morbidly obese patients were randomly assigned to receive the Lapband or the SAGB. All the procedures were performed by the same surgeon. The primary end point was weight loss, and secondary end points were correction of comorbidities, early- and long-term complications, importance of food restriction, and improvement of quality of life. RESULTS: Initial weight loss was faster in the Lapband group, but weight loss was eventually identical in the 2 groups. There was a trend toward more early band-related complications and more band infections with the SAGB, but the study had limited power in that respect. Correction of comorbidities, food restriction, long-term complications, and improvement of quality of life were identical. Only 55% to 60% of the patients achieved an excess weight loss of at least 50% in both groups. There was no difference in the incidence of long-term complications. CONCLUSIONS: Gastric banding can be performed safely with the Lapband or the SAGB with similar short- and midterm results with respect to weight loss and morbidity. Only 50% to 60% of the patients will achieve sufficient weight loss, and close to 10% at least will develop severe long-term complications.     

Automated control of postoperative hypertension: a prospective, randomized multicenter study

Hypertension after a cardiac operation is a frequent phenomenon. Complications resulting from this include bleeding, disruption of vascular suture lines, subendocardial ischemia, and possible cerebrovascular accidents. Treatment with sodium nitroprusside has become accepted practice to prevent these complications. To improve control of arterial blood pressure, a closed-loop system for sodium nitroprusside administration was developed. A prospective, randomized multicenter study was carried out postoperatively in 180 cardiac surgical patients to evaluate the performance of this system compared with manual control of infusion. Adherence of mean arterial blood pressure to +/- 10% of the target blood pressure occurred 85% of the time with the automatic system and 61% of the time with manual regulation (p less than 0.0001). With the automatic system, there was less hypertension (9% versus 22%; p less than 0.0001) and hypotension (6% versus 22%; p less than 0.0001). The superior control of hypertension was achieved more rapidly with less requirement for nurse regulation of infusion rate. The superior control of blood pressure resulted in less chest tube drainage in the automatic mode (720 mL versus 840 mL; p less than 0.05).     

Long-term results of a prospective randomized study comparing two different antireflux techniques in orthotopic bladder substitution

PURPOSE: We compared the long-term functional results following two different reflux prevention techniques in orthotopic ileal bladder substitution in a prospective controlled randomized study. METHODS: The study included 60 patients for whom orthotopic bladder replacement was indicated. The treated patients were prospectively randomized into two groups: group I (30 patients) underwent ileal W neobladder with serous lined extramural tunnel and group II (30 patients) received hemi-Kock pouch with intussuscepted nipple valve. Laboratory evaluation included estimation of serum creatinine while radiological studies included IVU and voiding studies. Urodynamic evaluation was an integral part of our investigation. RESULTS: Patients and tumor characteristics were comparable between both groups. No operative or postoperative mortality were observed in either. Early complications were encountered in 5 (16.7%) and 4 (13.3%) patients in the two treated groups respectively (p=0.72) and most were treated conservatively. Twenty patients in group I and 19 in group II were evaluable. The mean follow up was 73.9+/-6.6 and 72.9+/-5.6 months in the treated groups respectively.Day and night time continence was comparable between both groups. Ascending studies demonstrated reflux in 3 (7.7%) of the reimplanted units in group I versus 2 (5.3%) in group II (p=0.81); IVU showed uretero-ileal anastomotic strictures in 2 renal units with both the serous lined extramural tunnel (5.1%) and the ileal nipple valve (5.3%) techniques (p=0.98). One patient in group I had pouch stone compared with 5 in group II (p=0.08). Urodynamic characteristics were also comparable in both groups. CONCLUSION: The study provided evidence that the long-term functional results following serous lined extramural tunnel are as equal as the nipple valve. Furthermore, it spares the use of extra-bowel length, does not need staples and allows retrograde endoscopic procedures.     

SLEEVEPASS: A randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results

Background

The long-term efficacy of laparoscopic Roux-en-Y gastric bypass (RYGB) in the treatment of morbid obesity has been demonstrated. Laparoscopic sleeve gastrectomy (SG) as a single procedure has shown promising short-term results, but the long-term efficacy of SG has not yet been demonstrated. The aim of this study was to determine the preliminary 30-day morbidity and mortality of RYGB and SG in a prospective multicenter randomized setting.

Methods

A total of 240 morbidly obese (BMI?=?35–66?kg/m2) patients evaluated by a multidisciplinary team were randomized to undergo either RYGB or SG. There were 117 patients in the RYGB group and 121 in the SG group; two patients had to be excluded after randomization. Both study groups were comparable regarding age, gender, BMI, and comorbidities.

Results

There was no 30-day mortality. The median operating time was significantly shorter in the SG group (66?min vs. 94?min, p?p?=?0.292). Nine (7.4 %) SG patients and 20 (17.1 %) RYGB patients had minor complications (p?=?0.023). The overall morbidity was 13.2 % after SG and 26.5 % after RYGB (p?=?0.010). There were three (2.5 %) early reoperations after SG and four (3.3 %) after RYGB (p?=?0.719).

Conclusions

At 30-day analysis SG is associated with a shorter operating time and fewer early minor complications compared to RYGB. There were no significant differences in major complications or early reoperations. Long-term follow-up is required to determine the effect on weight loss, resolution of obesity-related comorbidities, and improvement of quality of life.     

Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O

The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient’s perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.     

特拉唑嗪治疗良性前列腺增生及下尿路症状有效性和安全性的前瞻性多中心研究

目的 研究特拉唑嗪4 mg/d治疗良性前列腺增生(BPH)及下尿路症状(LUTS)的疗效和安全性.方法临床诊断为BPH患者120例,随机分为2组,每组60例,分别给予特拉唑嗪2 mg/d或4 mg/d治疗2个月,比较2组患者治疗前后血压和IPSS、最大尿流率的变化,以及各种不良反应发生率.结果 2 mg和4 mg组完成治疗分别为46例和54例.2组年龄和治疗前基础血压、IPSS评分和最大尿流率比较差异无统计学意义.2组最大尿流率改善＞30%者分别为11例(23.9%)和25例(46.3%)(P=0.02).2组患者总体耐受性均良好,不良反应发生率低且程度轻微.结论 特拉唑嗪4 mg/d治疗BPH/LUTS在症状评分和最大尿流率改善效果优于2 mg/d,患者不良反应发生率低,总体耐受良好.

Abstract：

Objective To compare the efficacy and safety of 2 mg/d and 4 mg/d of terazosin in the treatment of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS).Methods A total of 120 BPH patients were randomly divided into 2 groups receiving 2 mg or 4 mg terazosin per day for 2 months. Arterial blood pressure, International Prostatic Symptom Score (IPSS) and peak flow rate (Qmax) before and after treatment were compared while side effects were estimated. Results Forty-six patients receiving 2 mg and 54 patients receiving 4 mg terazosin completed this study. Patients' age and pre-treatment blood pressure, IPSS and Qmax had no difference between the 2 groups. The improvement of IPSS (including obstructive score, irritating score and total IPSS) and Qmax was significantly better in 4 mg group. The percentage of patients experiencing greater than 30% improvement in Qmax in the 4 mg treatment groups was significantly higher than that of the 2 mg group (46.3% vs 23.9%, P=0.02). Side effects were rare and mild in both groups.Conclusion The improvements of IPSS and Qmax are significantly greater in 4 mg treatment of terazosin than that of 2 mg with no obvious increase of side effects.     

One-year results of a prospective,randomised clinical trial comparing four meshes in laparoscopic inguinal hernia repair (TAPP)

Background  

A low rate of chronic pain and maximum postoperative comfort are the main goals today in inguinal hernia repair. This four-arm randomised trial compares these parameters after laparoscopic hernia repair (TAPP) with a standard heavyweight mesh (HW), a pure middleweight polypropylene mesh (MW), a lightweight composite polypropylene mesh (LW), or a titanised lightweight mesh (TLW). The primary endpoint of the study was the incidence of chronic pain of any severity at the site of hernia repair at 1 year.     

Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence

Introduction and hypothesis

This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence.

Methods

We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n?=?56) or TVT-O (n?=?50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal–Wallis, Wilcoxon, and Fisher’s exact tests as appropriate. P values of <0.05 were considered significant.

Results

Objective cure rates were better for TVT-O compared with TVT-S at 1 year (86 % and 63 % respectively, p?=?0.01). Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S. Quality of life scores through questionnaires improved in both groups and were not statistically different. Initial post-operative groin pain was more prevalent in the TVT-O group; however, this resolved quickly with time.

Conclusion

TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up.     

A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy.

BACKGROUND: The usefulness of video-assisted arthroscopic microdiscectomy for the treatment of a herniated lumbar disc has been studied previously. In the current prospective, randomized study, the results of this procedure were compared with those of conventional open laminotomy and discectomy. METHODS: Sixty patients who had objective evidence of a single intracanalicular herniation of a lumbar disc caudad to the first lumbar vertebra were randomized into two groups consisting of thirty patients each; Group 1 was managed with open laminotomy and discectomy, and Group 2 was managed with video-assisted arthroscopic microdiscectomy. None of the patients had had a previous operation on the low back, and all had failed to respond to nonoperative measures. Analysis of the outcomes of both procedures was based on the patient's self-evaluation before and after the operation, the preoperative and postoperative clinical findings, and the patient's ability to return to a functional status. The patients were followed for nineteen to forty-two months postoperatively. RESULTS: On the basis of the patient's preoperative and postoperative self-evaluation, the findings on physical examination, and the patient's ability to return to work or to normal activity, twenty-eight patients (93 percent) in Group 1 and twenty-nine patients (97 percent) in Group 2 were considered to have had a satisfactory outcome. The mean duration of postoperative disability before the patients were able to return to work was considerably longer in Group 1 than in Group 2 (forty-nine compared with twenty-seven days). The patients in Group 1 used narcotics for a longer duration postoperatively. No neurovascular complications or infections were encountered in either group. CONCLUSIONS: Although the rate of satisfactory outcomes was approximately the same in both groups, the patients who had had an arthroscopic microdiscectomy had a shorter duration of postoperative disability and used narcotics for a shorter period. These findings suggest that arthroscopic microdiscectomy may be useful for the operative treatment of specific symptoms, including radiculopathy, that are caused by lumbar disc herniation, provided that patients are properly selected--that is, they must have a herniated disc at a single level as confirmed on imaging studies, have failed to respond to nonoperative management, have no evidence of spinal stenosis, and have a herniation not exceeding one-half of the anteroposterior diameter of the spinal canal. Moreover, the surgeon must be familiar with this technique and must have received training in its use.     

Gastrointestinal recovery after laparoscopic colectomy: results of a prospective, observational, multicenter study

Background  

Although evidence suggests that laparoscopic colectomy (LC) results in faster gastrointestinal (GI) recovery than open bowel resection, previous studies were performed at single institutions or generally not controlled for diet introduction or perioperative care, making the results difficult to interpret. A prospective, observational, multicenter study was planned to investigate GI recovery, length of hospital stay (LOS), and postoperative ileus (POI)-related morbidity after LC.