To compare the 1-year (previously published) and 3-year objective and subjective cure rates, and complications, related to the use of a collagen-coated transvaginal mesh for anterior vaginal wall prolapse against a conventional anterior repair.
Randomised controlled study.
Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
A total of 138 women, of 55 years of age or older, admitted for stage =2 anterior vaginal wall prolapse.
The women scheduled for primary anterior vaginal wall prolapse surgery were randomised between conventional anterior colporrhaphy and surgery with a collagen-coated prolene mesh. All patients were evaluated using the Pelvic Organ Prolapse Quantification (POP-Q) assessment before and after surgery. Symptoms related to pelvic organ prolapse were evaluated using the Pelvic Floor Impact Questionnaire (PFIQ-7) and the Pelvic Floor Distress Inventory (PFDI-20).
Comparison of the first 20 procedures with the subsequent 127 demonstrated that there was considerable improvement in time of cuff closure (p = .04); sacral dissection (p = .004); anterior (p = .006), posterior, (p = .003), and sacral (p = .003) mesh attachment; peritoneal closure (p
The use of meshes to repair incisional hernias has been shown to reduce the recurrence rate, though it may increase the risk of surgical site infection. This is one of the most feared and devastating complications of surgical abdominal wall repair. The aim of this work is to describe a new surgical technique that was used to treat two patients suffering from chronic prosthesis infection. Additionally, the outcome of this procedure will be analyzed in terms of its safety, subsequent site infection and recurrence prevention. Two case reports are presented. The procedure was based on a wide surgical excision of the infected prosthesis and the surrounding tissues, plus abdominal wall repair with biological prosthesis. Both patients experienced an uneventful postoperative course. Infection of the surgical site resolved following the procedure and, after a mean follow-up of 36 months, no recurrences of the incisional hernia had occurred. This unique surgical technique not only proved to be safe, but it also solved the chronic prosthesis infection through its use of radical excision, without any postoperative complications or recurrence. This technique confirmed that biological prostheses can be used safely and effectively for implantation in sites of infection.
To investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy.
A randomised controlled study.
Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
Women aged 55 years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage 2 or higher.
Women scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire.
The primary outcome was objective cure, defined as prolapse below POP-Q stage 2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications.
In total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.9 ± 6.4 years versus 64.7 ± 6.6 years, respectively; mean ± SD). The objective cure rate was 39.8% (95% CI 28.6-50.9%) in the anterior colporrhaphy group, compared with 88.1% (95% CI 80.7-95.6%) in the mesh group (P
To determine a syndrome score threshold on PFDI or PFIQ predictive of a significant improvement in post-operative functional results.
A retrospective case review (Canadian Task Force Classification II-2).
University and research hospital.
Women diagnosed with pelvic organ prolapse and repaired with synthetic vaginal mesh.
Quality of life was arbitrarily considered to have improved significantly if the score decreases by more than 50% between pre-operatively and 36 months post-operatively. We investigated the pre-operative cut-off score predictive of no quality of life improvement at M36 from a prospective trial for surgical pelvic organ prolapse treatment.
The most accurate pre-operative cut-off score predicting a failure to improve quality of life at 36 months post-operatively was 62/300 (PFDI Score). This cut-off value had a positive predictive value of 83.6% and specificity of 62.1%. No significant threshold was obtained from the PFIQ score.
The intensity of symptoms before surgery may interfere as a predictive factor for outcome.
The objective was to make a cost analysis of incisional hernia repair by suture repair or prosthetic mesh repair. The study included 44 patients who underwent hernia repair between 1991 and 2000. The rate of recurrent incisional hernia after more than 1 year with associated costs was registered. In 1996, the technique of incisional hernia repair was changed from suture repair to mesh repair. With a mesh repair, zero out of 19 patients presented with a recurrence at follow-up, and with suture repair, five out of 13 had a recurrence (P
Laparoscopic hernia repair has often been criticized for its high costs.
To compare the costs of laparoscopic and open hernia repair, 40 patients were randomized for either transabdominal laparoscopic or Lichtenstein mesh repair (under local anesthesia) in a day-case surgery unit.
Median operative times for the laparoscopic and open groups were 62 and 65 min, respectively. Postoperative pain was comparable for the two groups. The period before return to normal life was 14 days in the laparoscopic group and 21 days in the open group. The hospital costs were 2051 FIM ($1 US = 4.6 FIM) higher in the laparoscopic group, but the total costs for employed patients (including expenses due to lost work days) were lower.
Although the Lichtenstein operation is cheaper for the hospital, the total costs for working patients are lower with the laparoscopic technique, when the cost of lost work days is factored into overall expense.
Comment On: Surg Endosc. 1998 Oct;12(10):1197-89745055
Evaluation of cost-effectiveness of new surgical techniques is important. As the data on incontinence procedures are scarce, we evaluated the cost-effectiveness of tension-free vaginal tape procedure and laparoscopic mesh colposuspension as a primary surgical treatment for female stress urinary incontinence.
In four university teaching hospitals and two central hospitals 128 stress incontinent women were randomized to tension-free vaginal tape procedure (n=70) or laparoscopic mesh colposuspension (n=51) in order to investigate the clinical performance of these two procedures. Primary objective clinical outcome measures were: stress test and 48-h pad test. Secondary subjective outcome measures were health-related quality of life measured in terms of visual analogue scale and Urinary Incontinence Severity Score. Alongside the clinical trial, a cost-effectiveness analysis for the main outcome measures was performed.
The changes in the 48-h pad test result did not reach statistical significance (p=0.105). When the visual analogue scale or Urinary Incontinence Severity Score are used as the outcome measure, the tension-free vaginal tape is more cost-effective than laparoscopic mesh colposuspension over a follow-up period of one year (p
Steinberg-Bernstein Centre for Minimally-Invasive Surgery and Innovation, McGill University Health Centre, Montreal, Quebec, Canada; Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.
Parastomal hernia (PSH) is common after stoma formation. Studies have reported that mesh prophylaxis reduces PSH, but there are no cost-effectiveness data. Our objective was to determine the cost effectiveness of mesh prophylaxis vs no prophylaxis to prevent PSH in patients undergoing abdominoperineal resection with permanent colostomy for rectal cancer.
Using a cohort Markov model, we modeled the costs and effectiveness of mesh prophylaxis vs no prophylaxis at the index operation in a cohort of 60-year-old patients undergoing abdominoperineal resection for rectal cancer during a time horizon of 5 years. Costs were expressed in 2012 Canadian dollars (CAD$) and effectiveness in quality-adjusted life years. Deterministic and probabilistic sensitivity analyses were performed.
In patients with stage I to III rectal cancer, prophylactic mesh was dominant (less costly and more effective) compared with no mesh. In patients with stage IV disease, mesh prophylaxis was associated with higher cost (CAD$495 more) and minimally increased effectiveness (0.05 additional quality-adjusted life years), resulting in an incremental cost-effectiveness ratio of CAD$10,818 per quality-adjusted life year. On sensitivity analyses, the decision was sensitive to the probability of mesh infection and the cost of the mesh, and method of diagnosing PSH.
In patients undergoing abdominoperineal resection with permanent colostomy for rectal cancer, mesh prophylaxis might be the less costly and more effective strategy compared with no mesh to prevent PSH in patients with stage I to III disease, and might be cost effective in patients with stage IV disease.
In recent years long-term discomfort after inguinal hernia surgery has become an issue of great concern to hernia surgeons. Long-term results on discomfort from large randomised studies are sparse.
One-thousand one-hundred and eighty-three patients were randomised in a multicentre trial with the primary aim of comparing recurrence rates after laparoscopic TAPP and Shouldice repair. Evaluating late discomfort and its possible risk factors were secondary objectives, and are reported here. The patients were clinically examined after 1 and 5 years, and answered questionnaires 2 and 3 years postoperation.
Of 1,068 operated patients, 867 were eligible for analysis after 5 years (81.2%). The percentage of patients experiencing discomfort of any kind were 8.5% in the TAPP group and 11.4% (p = 0.156) in the Shouldice group. Although discomfort was usually mild it was severe for 0.2 and 0.7%, respectively. Severe pain the first postoperative week was a risk factor for late discomfort in the Shouldice group (OR 2.25, P = 0.022) but not in the TAPP group. No other risk factor for late discomfort was found.
There was no difference between late discomfort at five-year follow-up after laparoscopic TAPP and Shouldice repair. Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in Shouldice patients.