Dataset Information

ROBOTIC PELVIC SURGERY (ROPES) I: Robotic Extended Resection for Locally Advanced and Recurrent Pelvic Malignancy: An IDEAL 2B Prospective Study to Design a Phase III Randomised Controlled Trial

ABSTRACT: 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

DISEASE(S): Cancer-womb (uterine Or Endometrial Cancer),Cancer-bowel-anal,Cancer-bladder,Cancer-sarcoma (also See 'bone')-soft Tissue,Cancer-cervical (cervix),Cancer-prostate,Locally Advanced Pelvic Malignancy,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-neuroendocrine Tumour (net),Recurrent Pelvic Malignancy

PROVIDER: 2712134 | 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 â¥ 12 months with surgical success at â¥ 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.

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).

Project description:Background: MicroRNAs (miRNAs) are small, non-coding, RNA molecules which regulate numerous cellular processes. Specific miRNA may be abnormally down-regulated or up-regulated in colorectal cancer and have been found associated with prognosis or response to treatments. However, no study has ever addressed their predictive role in rectal cancer. Therefore, we used microarray technology and RT-PCR to profile miRNA expression patterns in patients (pts) with rectal cancer, with the aim to identify a specific M-bM-^@M-^\signatureM-bM-^@M-^] associated with pathological complete response after neoadjuvant chemo-radiotherapy. Methods: 38 pts with locally advanced rectal cancer (cT3-4/N+) were treated with capecitabine-oxaliplatin and pelvic conformal radiotherapy (45 cGy) followed by surgery (after 6-8 weeks). Pathologic response was scored according to the tumor regression grade (TRG) scale. MiRNA expression profile was analysed by microarray on fresh frozen biopsies obtained before treatment start and confirmed by RT-PCR. The correlation between miRNA expression profile and the TRG coded as TRG1 (pathologic Complete Response-pCR) versus TRG >1 (no pCR) was assessed by statistical analysis methods specifically designed for this study. Findings: 14 miRNAs were selected by arrays analysis as differentially expressed in TRG1 pts and 13 were confirmed by RT-PCR. In particular, 11 miRNAs (miR-1183, miR-483-5p, miR-622, miR-125a-3p, miR-1224-5p, miR-188-5p, miR-1471, miR-671-5p, miR-1909*, miR-630 and miR-765) were significantly up-regulated in TRG1 pts, while 2 miRNAs were under -expressed (miR-1274b and miR-720). miR-622 and miR-630 showed 100% sensitivity and specificity in selecting TRG1 cases and were significantly correlated with EGFR (M-OM-^G2=11M-bM-^@M-"793; p= 0M-bM-^@M-"001) and TS expression (M-OM-^G2=10M-bM-^@M-"589; p= 0M-bM-^@M-"001). Interpretation: A set of 13 miRNAs is strongly associated with pathologic complete response and may represent a specific marker of response to chemo-radiotherapy in locally advanced rectal cancer. Experiments were performed on purified RNA from preoperatory biopsies of 38 patients with histological diagnosis of rectal adenocarcinoma invading through the intestinal wall and/or with pelvic lymph node involvement as evaluated by endorectal ultrasonography (uT3-T4 and/or uN+). Patients were treated with neoadjuvant chemo-radiotherapy (capecitabine + oxaliplatin in combination with 45 Gy of pelvic conformal radiotherapy). Patients have been divided in the following two groups: group A those who had obtained a pathologic complete response M-bM-^@M-^S TRG 1, including the patient without detectable disease who refused surgery, group B any pathologic response other than complete.

Project description:Interventions: The intervention in the RoboSTER trial is the use of the da Vinci Xi surgical robot to resect advanced or recurrent abdominal tumours (intervention name: robot-assisted multivisceral complete soft tissue extended resection). Intra-corporeal abdominal tumour resection (ICATR) involves performing resection using the Da Vinci Xi Surgical Robot’s arms internally, within the body. The majority of the surgery is performed by a colorectal surgeon, however urological surgeons and gynaecological surgeons are often involved and perform specialty specific procedures as parts of the overall surgery (ie: a urologist may perform a radical cystectomy). Abdominal tumour resection involves excision of the tumour and associated attached viscera, this may include bowel, and genitourinary organs. The surgical approach for ICATR follows standardised oncological principles to obtain clear surgical margins and appropriate resection of draining lymph node tissue, as performed for the traditional open approach (please see Comparator/Control Treatment section). The use of the robotic device will be confined to the instrument’s limitations, all remaining components of the surgery will be performed via routine practice. Reconstruction of gastrointestinal and urinary systems will be undertaken using a minimally invasive approach. The approximate duration of the intervention will be 13 hours, however this depends on each individual case. Adherence to the intervention is monitored by patient surgical case reports within electronic medical records and intra-operative surgical forms. Primary outcome(s): Safety of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection. Safety of robotic surgery will be measured by the overall 30-day complication rate, calculated from the time surgery begins. Clavien-Dindo Grading System will be used to determine the 30-day complication rate. Complications will be collected by surgeon completed postoperative clinical data form alongside electronic medical records. Note: all primary outcomes have equal weighting.[30 day time period, from when surgery commences.];Feasibility of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection. Feasibility will be determined firstly by the cumulative time taken for eligible patient recruitment to the intervention. The eligibility date will be collected from patient consultations (screening form) and the trial inclusion date from the date of consent (consent form).[Time from first eligible consultation with surgeon until signing of the consent form for inclusion in the research trial.];Feasibility of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection. Feasibility will be determined secondly by treatment retention, defined as the proportion of patients to not cross over to conventional open surgery (pre-operatively) in the absence of any clinical indication. Treatment retention will be collected from patient surgical records and intraoperative clinical data forms.[Peri/intra-operative] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

Dataset Information

ROBOTIC PELVIC SURGERY (ROPES) I: Robotic Extended Resection for Locally Advanced and Recurrent Pelvic Malignancy: An IDEAL 2B Prospective Study to Design a Phase III Randomised Controlled Trial

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