Multicenter clinical trial and social economic cost-effect analysis of the standard appliance of robotic surgery in advanced Gynecology
Ontology highlight
ABSTRACT:
DISEASE(S): Cervical Cancer, Ovarian Cancer, Endometrial Carcinoma, Intestinal Adhesion, Deep Infiltrating Endometrosis, Ovarian Cystis In Pregnancy, Uterine Prolaps, Uterine Diverticulum, Cervical Atresia
PROVIDER: 2669986 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Sacrocolpopexy has been dubbed the âgold standardâ repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for ⥠12 months with surgical success at ⥠12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004). This case-control study compared single genotypes of 10 cases to 40 controls. All subjects were identified as Caucasian. Cases were women who experienced early overt POP recurrence after robotic sacrocolpopexy, and controls were randomly selected women with long term success after the same procedure.
2016-06-01 | E-GEOD-63236 | biostudies-arrayexpress
Project description:Sacrocolpopexy has been dubbed the “gold standard” repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for ≥ 12 months with surgical success at ≥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004).
2016-06-01 | GSE63236 | GEO
Project description:Interventions: experimental group:robotic NOSES combined with perioperative ERAS
Primary outcome(s): Complication rate within 30 days after surgery
Study Design: Single arm
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Project description:Interventions: Surgeon will perform Right hemicolectomy performed by a robotic surgery using the da Vinci Xi surgical robotic
A robotic right hemicolectomy is performed with the da VINCI Xi surgical robot using up to four robotic arms to control small instruments introduced into the abdomen through 3 – 6 small incisions on the abdomen measuring around 8mm. One robotic arm is used for a camera. The tumour is removed through another incision (about 5cm to 8cm). The approximate duration of surgery is two hours. Surgeons will be required to electronically record every operation they perform in this study.
Primary outcome(s): To determine if performing right hemicolectomy robotically compared with laparoscopic hemicolectomy in patients with adenocarcinoma of the caecum, ascending or proximal transverse colon improves surgical morbidity.
Surgical morbidity/mortality up to 90 days (as measured by Clavien-Dindo and the Comprehensive Complication Index).
.[90 days post-surgery.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy
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Project description:The purpose of this study is to compare two different surgical procedures for the treatment of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR study is for participants with cancer of the rectum for whom a laparoscopic operation (sometimes called "keyhole surgery") has been recommended by their surgeon.
In the past most rectal cancers were removed using "open" surgery. Open surgery involves a large cut down the middle of the patient’s abdomen to allow the surgeon to see and take out the cancer. On a previous study showed that using laparoscopic surgery to remove colorectal cancers was as good as open surgery for curing cancer.
There is now another option to remove rectal cancers, which involves using a robotic system with laparoscopic surgery. This type of surgery is called "robotic-assisted" laparoscopic surgery and is now becoming widely used by surgeons to remove cancers including the rectum, as well as for other non-cancer operations.
In order to perform robotic-assisted laparoscopic surgery, the surgeon sits at a robotic control unit a few feet away from the patient. Using the robotic control unit, the surgeon can see a clear video image of the patient’s abdomen and the operation site. The surgeon can perform the operation from the robotic control unit by controlling the movement of a set of robotic surgical instruments, guided by the video camera.
Like standard laparoscopic surgery, the surgeon is able to carry out the entire operation through a few small cuts in the abdomen. The camera of the robotic system provides a 3D high-definition magnified view of the operation site and the robotic system is also able to translate the movements of the surgeon’s hands into small precise movements inside the patient’s body.
We want to test whether robotic-assisted laparoscopic surgery is as good, or even better, at removing rectal cancers as standard laparoscopic surgery (actually Robotic-assisted laparoscopic surgery is used as standard of care in rectal cancer patients at University of California, Irvine Medical Center). We also want to investigate whether using robotic-assisted laparoscopic surgery reduces the number of times a laparoscopic operation needs to be converted to an open operation, and see whether using a robotic system can also shorten the length of time patients need to stay in hospital and if it reduces the number of complications patients may have during and after their operation.
| 2135815 | ecrin-mdr-crc
Project description:A brain consists of numerous distinct neurons arising from a limited number of progenitors, called neuroblasts in Drosophila. Each neuroblast makes a specific neuronal lineage. To unravel the transcriptional networks that underlie the development of distinct neuroblast lineages, we marked and isolated lineage-specific neuroblasts for RNA sequencing. We labeled particular neuroblasts throughout neurogenesis by activating a conditional neuroblast driver in specific lineages using various intersection strategies. The targeted neuroblasts were efficiently recovered using a custom-built device for robotic single cell picking. Transcriptome analysis on the mushroom body, antennal lobe, and type II neuroblasts besides non-selective neuroblasts, neurons, and glia revealed a rich repertoire of transcription factors expressed among neuroblasts in diverse patterns. In addition to those likely pan-neuroblast transcription factors, there exist many transcription factors selectively enriched or repressed in certain neuroblasts. The unique combinations of transcription factors present in different neuroblasts may govern the diverse lineage-specific neuron fates
2015-12-29 | GSE71104 | GEO
Project description:Social anxiety disorder is one of the most persistent and common anxiety disorders. Individually delivered psychological therapies are the most effective treatment options for adults with social anxiety disorder, but they are associated with high intervention costs. Therefore, the objective of this study was to assess the relative cost effectiveness of a variety of psychological and pharmacological interventions for adults with social anxiety disorder.A decision-analytic model was constructed to compare costs and quality adjusted life years (QALYs) of 28 interventions for social anxiety disorder from the perspective of the British National Health Service and personal social services. Efficacy data were derived from a systematic review and network meta-analysis. Other model input parameters were based on published literature and national sources, supplemented by expert opinion.Individual cognitive therapy was the most cost-effective intervention for adults with social anxiety disorder, followed by generic individual cognitive behavioural therapy (CBT), phenelzine and book-based self-help without support. Other drugs, group-based psychological interventions and other individually delivered psychological interventions were less cost-effective. Results were influenced by limited evidence suggesting superiority of psychological interventions over drugs in retaining long-term effects. The analysis did not take into account side effects of drugs.Various forms of individually delivered CBT appear to be the most cost-effective options for the treatment of adults with social anxiety disorder. Consideration of side effects of drugs would only strengthen this conclusion, as it would improve even further the cost effectiveness of individually delivered CBT relative to phenelzine, which was the next most cost-effective option, due to the serious side effects associated with phenelzine. Further research needs to determine more accurately the long-term comparative benefits and harms of psychological and pharmacological interventions for social anxiety disorder and establish their relative cost effectiveness with greater certainty.
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Project description:The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.
| 67720 | ecrin-mdr-crc
Project description:In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.
| 68193 | ecrin-mdr-crc
Project description:BACKGROUND:Recent studies provide evidence of improved clinical benefits associated with cardiac resynchronization therapy (CRT) optimization. Our analysis explores the cost-effectiveness of systematically optimized (SO, 3 times a year) vs. non-systematically optimized (NSO, less than 3 times a year) CRT, whatever the echo optimization method used (manual or SonR® automatic). A longitudinal cohort model was developed to predict clinical and economic outcomes for SO vs. NSO strategies over 5 years. The analysis was performed from the payer perspective. Data from CLEAR study post-hoc analysis was used with 199 pts with CRT pacemaker (CRT-P). The main economic outcome measure was incremental cost-effectiveness (ICER) expressed as cost per Quality Adjusted Life Years (QALY) gained. To assess the impact of data uncertainty, a sensitivity analysis was performed. The model also predicts outcomes for the two optimization strategies for CRT-D therapy vs. optimal medical treatment (OPT). RESULTS:At 1 year, ICERs for SO CRT vs. NSO CRT-P range between <euro> 22,226 (Spain) and <euro> 26,977 (Italy). Therefore, on the basis of a Willingness-To-Pay of <euro>30,000 per QALY, the SO method develops into a cost effective strategy from 1 year, onwards. These favorable outcomes are supported by the sensitivity analysis. Systematic optimization of CRT-D might also improve the cost-effectiveness of this device therapy by 27 % to 30 % dependent on the country analyzed, at 5 years. CONCLUSIONS:Our economic evaluation shows promising health economic benefits associated with SO CRT. These preliminary findings need further confirmation.
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