Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Adenocarcinoma,Rectal Neoplasms,Colorectal Surgery,Colorectal Cancer
PROVIDER: 2285085 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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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).
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Project description:Interventions: This IDEAL 2B observational study will assess the current use of robotic assisted extended resection for locally advanced and recurrent pelvic malignancies. Patients being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study. This study is observational and so it will not change which treatment the patient receives.
INDICATION: Locally advanced or recurrent pelvic cancer requiring extended resection
PRIMARY OBJECTIVES:
To determine the current case volume and current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres.
SECONDARY OBJECTIVES:
1. To obtain pilot outcome data including clinical, pathological and patient reported outcome measures (PROMS).
2. To assess feasibility and plan a future prospective phase III randomised controlled trial of robotic versus non robotic extended resection in locally advanced or recurrent pelvic cancer.
TRIAL DESIGN: Observational IDEAL 2B prospective study
OBSERVATIONAL STUDY ARMS:
Cases: Robotic extended resection for locally advanced or recurrent pelvic malignancy
Controls: Non-robotic extended resection for locally advanced or recurrent pelvic malignancy
For participants there will be no change to their treatment. Their data will be collected from medical records. They will be invited to participate in PROMS questionnaires at:
1. 7 days post operatively
2. 3 months
3. 6 months
4. One year
Measures used will take approximately 30 minutes at each time point:
Generic Measures:
•EORTC QLQC30- This is a questionnaire specifically designed to assess the QOL of cancer patients.
•QOR15- Quality of Recovery - T
Primary outcome(s): To determine the current case volume of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres. This will be assessed by a study specific questionnaire and data will be entered onto redcap at participating sites. [This primary timepoint will be at the time of selection for surgery, i.e. at initial enrolment into the study. ];To determine current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres.
The surgical team will enter data on redcap based on a patient selection for robotic surgery questionnaire designed specifically for the study. [for the primary end point, it will be assessed at time of selection for surgery
]
Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective
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