scholarly journals Laparoscopic sacrohysteropexy versus vaginal hysterectomy and apical suspension: 7-year follow-up of a randomized controlled trial

2021 ◽  
Author(s):  
Matthew L. Izett-Kay ◽  
Philip Rahmanou ◽  
Rufus J. Cartwright ◽  
Natalia Price ◽  
Simon R. Jackson
Keyword(s):  
Vaginal Hysterectomy ◽  
Uterine Prolapse ◽  
Controlled Trial ◽  
Apical Prolapse ◽  
Apical Suspension ◽  
Vaginal Length ◽  
Patient Reported ◽  
Laparoscopic Sacrohysteropexy ◽  
Total Vaginal Length

Abstract Introduction and hypothesis Laparoscopic mesh sacrohysteropexy offers a uterine-sparing alternative to vaginal hysterectomy with apical suspension, although randomised comparative data are lacking. This study was aimed at comparing the long-term efficacy of laparoscopic mesh sacrohysteropexy and vaginal hysterectomy with apical suspension for the treatment of uterine prolapse. Methods A randomised controlled trial comparing laparoscopic mesh sacrohysteropexy and vaginal hysterectomy with apical suspension for the treatment of uterine prolapse was performed, with a minimum follow-up of 7 years. The primary outcome was reoperation for apical prolapse. Secondary outcomes included patient-reported mesh complications, Pelvic Organ Prolapse Quantification, Patient Global Impression of Improvement in prolapse symptoms and the International Consultation on Incontinence Questionnaire Vaginal Symptoms, Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and PISQ-12 questionnaires. Results A total of 101 women were randomised and 62 women attended for follow-up at a mean of 100 months postoperatively (range 84–119 months). None reported a mesh-associated complication. The risk of reoperation for apical prolapse was 17.2% following vaginal hysterectomy (VH) and 6.1% following laparoscopic mesh sacrohysteropexy (LSH; relative risk 0.34, 95% CI 0.07–1.68, p = 0.17). Laparoscopic sacrohysteropexy was associated with a statistically significantly higher apical suspension (POP-Q point C −5 vs −4.25, p = 0.02) and longer total vaginal length (9 cm vs 6 cm, p < 0.001). There was no difference in the change in ICIQ-VS scores between the two groups (ICIQ-VS change −22 vs −25, p = 0.59). Conclusion Laparoscopic sacrohysteropexy and vaginal hysterectomy with apical suspension have comparable reoperation rates and subjective outcomes. Potential advantages of laparoscopic sacrohysteropexy include a lower risk of apical reoperation, greater apical support and increased total vaginal length.

scholarly journals Comparison of treatment outcomes for native tissue repair and sacrocolpopexy as apical suspension procedures at the time of hysterectomy for uterine prolapse

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sumin Oh ◽  
E. Kyung Shin ◽  
Sowoon Hyun ◽  
Myung Jae Jeon
Keyword(s):  
Treatment Outcomes ◽  
Tissue Repair ◽  
Uterine Prolapse ◽  
Reoperation Rate ◽  
Complication Rates ◽  
Native Tissue Repair ◽  
Apical Suspension ◽  
Native Tissue ◽  
Surgical Failure

AbstractConcomitant apical suspension should be performed at the time of hysterectomy for uterine prolapse to reduce the risk of recurrent prolapse. Native tissue repair (NTR) and sacrocolpopexy (SCP) are commonly used apical suspension procedures; however, it remains unclear which one is preferred. This study aimed to compare the treatment outcomes of NTR and SCP in terms of surgical failure, complication and reoperation rates. Surgical failure was defined as the presence of vaginal bulge symptoms, any prolapse beyond the hymen, or retreatment for prolapse. This retrospective cohort study included 523 patients who had undergone NTR (n = 272) or SCP (n = 251) along with hysterectomy for uterine prolapse and who had at least 4-month follow-up visits. During the median 3-year follow-up period, the surgical failure rate was higher in the NTR group (21.3% vs 6.4%, P < 0.01), with a low rate of retreatment in both groups. Overall complication rates were similar, but complications requiring surgical correction under anesthesia were more common in the SCP group (7.2% vs 0.4%, P < 0.01). As a result, the total reoperation rate was significantly higher in the SCP group (8.0% vs 2.6%, P = 0.02). Taken together, NTR may be a preferred option for apical suspension when hysterectomy is performed for uterine prolapse.

Total vaginal length: Does it matter for assessing uterine prolapse?

2018 ◽  
Vol 30 (8) ◽  
pp. 1279-1282 ◽  
Author(s):  
Myriam Girgis ◽  
Ka Lai Shek ◽  
Hans Peter Dietz
Keyword(s):  
Uterine Prolapse ◽  
Vaginal Length ◽  
Total Vaginal Length

scholarly journals Non- or Minimally Displaced Distal Radial Fractures in Adult Patients: Three Weeks versus Five Weeks of Cast Immobilization—A Randomized Controlled Trial

2018 ◽  
Vol 08 (01) ◽  
pp. 043-048 ◽  
Author(s):  
A. Bentohami ◽  
J. Vermeulen ◽  
N. L. Sosef ◽  
N. de Korte ◽  
T. S. Bijlsma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Adult Patients ◽  
Cast Immobilization ◽  
Distal Radial Fractures ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Secondary Displacement

Background Patients with non- or minimally displaced distal radial fractures, that do not need repositioning, are mostly treated by a short-arm cast for a period of 4 to 6 weeks. A shorter period of immobilization may lead to a better functional outcome. Purpose We conducted a randomized controlled trial to evaluate whether the duration of cast immobilization for patients with non- or minimally displaced distal radial fractures can be safely shortened toward 3 weeks. Materials and Methods The primary outcomes were patient-reported outcomes measured by the Patient-Related Wrist Evaluation (PRWE) and Quick Disability of Arm, Shoulder and Hand (QuickDASH) score after 1-year follow-up. Secondary outcome measures were: PRWE and QuickDASH earlier in follow-up, pain (Visual Analog Scale), and complications like secondary displacement. Results Seventy-two patients (male/female, 23/49; median age, 55 years) were included and randomized. Sixty-five patients completed the 1-year follow-up. After 1-year follow up, patients in the 3 weeks immobilization group had significantly better PRWE (5.0 vs. 8.8 points, p = 0.045) and QuickDASH scores (0.0 vs. 12.5, p = 0.026). Secondary displacement occurred once in each group. Pain did not differ between groups (p = 0.46). Conclusion Shortening the period of immobilization in adult patients with a non- or minimally displaced distal radial fractures seems to lead to equal patient-reported outcomes for both the cast immobilization groups. Also, there are no negative side effects of a shorter period of cast immobilization. Therefore, we recommend a period of 3 weeks of immobilization in patients with distal radial fractures that do not need repositioning.

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

Efficacy and toxicity according to hormone therapy used in the CHHiP trial.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 316-316 ◽  
Author(s):  
Alison Tree ◽  
Clare Griffin ◽  
Emma Hall ◽  
David P. Dearnaley ◽  
Keyword(s):  
Erectile Function ◽  
Cox Regression ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
Trend Test ◽  
Chi Square ◽  
Patient Reported ◽  
Toxicity Analysis ◽  
Randomised Controlled

316 Background: CHHiP (CRUK/06/016) is a multicentre randomised controlled trial which investigated the use of moderately hypofractionated radiotherapy (RT) dose schedules for treatment of localised prostate cancer. 97% of participants (pts) had concurrent androgen deprivation therapy (ADT). Luteinising Hormone Releasing Hormone analogues (LHRHa) and bicalutamide 150mg (BIC) daily were permitted. This exploratory analysis investigates whether both ADT regimens show similar efficacy and whether BIC has the propensity to preserve erectile function. Methods: In CHHiP, 2700 pts received LHRH and 403 BIC, median duration 5.6 months. The primary endpoint was biochemical or clinical failure (BCF). ADT groups were compared with Cox regression adjusted forage, NCCN risk group, Gleason score,T-stage and stratified by RT dose. A key secondary endpoint was erectile function assessed by clinicians (LENTSOM subjective erectile function for vaginal penetration score) and pts (single items within UCLA-PCI and EPIC-50 questionnaires) at 2 years. 195/875 (22%) pts were excluded from this toxicity analysis as they had erectile dysfunction pre-ADT (grade (G) 3/4 LENTSOM). A chi square trend test compared ADT regimens. Results: Baseline demographics were similar except BIC pts were significantly younger (median 67 years BIC, 69 years LHRHa). With a median follow-up of 9.2 years, there was no evidence of a difference in BCF with an adjusted hazard ratio 0.95 (95% CI 0.75-1.20), p = 0.657. Eight year BCF rates were 80.7% (95%CI 79.0-82.2) and 80.3% (95%CI 75.8-84.0) for LHRHa and BIC pts respectively. At two years, LENTSOM erectile function was significantly worse (p < 0.0001) for LHRHa pts with 93/585 (16%), 95/585 (16%) and 125/585 (21%) G2, G3 and G4, compared to 3/68 (4%), 5/68 (7%) and 9/68 (13%) in BIC. At 2 years, the ability to have an erection, as reported by pts, was graded poor and very poor in 73/278 (26%) and 57/278 (21%) LHRHa pts and 5/23 (22%) and 4/23 (17%) in BIC pts (p = 0.584). Conclusions: There was no evidence of a difference in efficacy according to ADT received. BIC preserved clinician assessed (LENTSOM) erectile function at 2 years but patient reported outcomes did not show statistically significant differences with type of ADT. Clinical trial information: 97182923.

scholarly journals Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marjolein M. Iversen ◽  
Jannicke Igland ◽  
Hilde Smith-Strøm ◽  
Truls Østbye ◽  
Grethe S. Tell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Well Being ◽  
Foot Ulcers ◽  
Control Group ◽  
Patient Reported ◽  
Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

scholarly journals Responsiveness of EQ-5D in Patients With a Distal Radius Fracture

Hand ◽  
2017 ◽  
Vol 13 (5) ◽  
pp. 572-580 ◽  
Author(s):  
Johanna Rundgren ◽  
Anders Enocson ◽  
Cecilia Mellstrand Navarro ◽  
Gunnar Bergström
Keyword(s):  
Distal Radius Fracture ◽  
Distal Radius ◽  
Controlled Trial ◽  
Roc Curves ◽  
Change Score ◽  
Radius Fracture ◽  
External Criterion ◽  
Patient Reported ◽  
External Responsiveness

Background: The EuroQol Group 5-Dimension (EQ-5D) questionnaire is frequently used as an outcome measure of general patient-reported health-related quality of life (HRQoL). We evaluated the internal and external responsiveness of EQ-5D (specifically EQ-5Dindex score) in patients with a surgically treated distal radius fracture. Methods: Within the context of a randomized controlled trial (RCT), 132 patients with a surgically treated distal radius fracture filled out EQ-5D and Patient-Rated Wrist Evaluation (PRWE-Swe) at baseline (preinjury state), and at 3 and 12 months. Internal responsiveness was evaluated by calculating mean change score and standardized response mean (SRM) of the EQ-5Dindex scores. External responsiveness was evaluated with PRWE-Swe as the external criterion. PRWE-Swe was used to define 4 subgroups of patients with different clinical outcomes. The ability of EQ-5Dindex change score to discriminate between these subgroups was analyzed with logistic regression, receiver operating characteristic (ROC) curves, and area under the ROC curves (AUROCs). Correlation analysis was made with Spearman’s ρ test. Results: The mean change in EQ-5Dindex score from baseline to the 3-month follow-up was −16.1 and from the 3- to the 12-month follow-up was 7.6. The corresponding SRMs were large (0.93) and small to moderate (0.47). Analysis of external responsiveness displayed odds ratios >1 and AUROCs between 0.70 and 0.76 in all 4 subgroups. The proportion of patients correctly classified into the 4 subgroups by the EQ-5Dindex change scores was 78% to 94%. Spearman’s ρ was 0.35. Conclusion: EQ-5D displayed an overall acceptable to good responsiveness in patients with a distal radius fracture. It may thus be used as a measure of HRQoL in this patient group.

OP27 Engaging Patients: The EuroCAB Programme

2019 ◽  
Vol 35 (S1) ◽  
pp. 6-6
Author(s):  
François Houyez ◽  
Rob Camp
Keyword(s):  
Rare Diseases ◽  
Controlled Trial ◽  
Target Population ◽  
Pricing Policy ◽  
Health Technologies ◽  
Advisory Boards ◽  
Patient Reported ◽  
Community Advisory Boards

IntroductionWhen developing a health technology that requires clinical studies, developers institute working relations with clinical investigators. In certain diseases areas, patients' representatives create their own advisory boards, which proved their utility in the early 90s, in particular for the development of products to treat HIV infection. Inspired by this model, where patients with a same disease join and meet with relevant developers and discuss all aspects of the research, the European Organisation for Rare Diseases (EURORDIS) proposes a new programme of such Community Advisory Boards for Rare Diseases (CAB).MethodsFor this programme, EURORDIS invites developers to sign a Charter of principles when engaging with patients, and provides guidelines on CABs, together with a mentoring programme for patients’ networks that are less experienced with the development and the evaluation of health technologies. CABs are driven by patients who set their agenda, who sign a Memorandum of Understanding with each developer, and who organise the sessions. Sessions typically last for two to four days during which different meetings with different developers can take place, or trainings. All meetings can take place under confidentiality arrangements, and minutes are written to keep track and to follow-up with all points discussed. Participants and agendas are made publicResultsAs of 2018, four CABs exist and operate (for tuberous sclerosis complex, for scleroderma, for cystic fibrosis, for Duchenne muscular dystrophy) and 18 others are in discussion with many due to start in 2019. Topics discussed cover the target population, the study feasibility, the endpoints including patient reported outcomes, the comparator choice and/or the acceptance of a placebo controlled trial, the quality of life, the practical aspects of the trials, and the identification of previously unknown or unmet patient needs/preferences. For products which are more advanced in their life-cycle, discussions can also cover compassionate use, pricing policy, relative efficacy etc.ConclusionsThis represents a well-structured programme for the engagement of patients, where collective thinking and exchange between different patients ensure high quality dialogue with developers and can inform HTA also.

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