Dataset Information

A La CaRT: Australasian Laparoscopic Cancer of the Rectum TrialA phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer

ABSTRACT: Interventions: Two types of surgery are currently available in the treatment of rectal cancer: open laparotomy and rectal resection and laparoscopic-assisted rectal resection. While open laparotomy (an incision into the abdomen) and surgical resection is currently the standard of care for rectal cancer, laparoscopic-assisted resection (key-hole” surgery to resect the tumour, performed under the guidance of a video camera) has emerged as a new treatment option for rectal cancer. This technique achieves removal of the rectal tumour with minimally invasive surgery, and potentially achieves better recovery and shorter stays in hospital post-operatively. Patients will be randomised to receive one of the two surgical treatments to remove the primary rectal cancer - i.e. Open Laparotomy and Rectal Resection or Laparoscopic-assisted Rectal Resection. Primary outcome(s): To determine whether laparoscopic-assisted resection is not inferior to open rectal resection as a safe, effective oncologic approach to rectal cancer.[Pre-operative staging and evaluation of disease will be determined by Computerised Tomography (CT) scan, and pelvic Magnetic Resonance Imaging) MRI or CT scan and Endorectal ultrasound. Pathology specimens obtained at surgery will be reviewed by a Pathology Review Committee to assess a composite of oncologic parameters which must be met for surgical resection to be successful. These parameters which form the primary endpoint are: Circumferential margin greater than or equal to 1mm Distal resected margin greater than or equal to 2cm (or greater than or equal to 1cm with clear frozen section in the low rectum) Completeness of total mesorectal excision (TME)] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),The Study Compares Two Types Of Surgery For Rectal Cancer Stage T 0-3, N 0-1, M 0-laparoscopic-assisted Resection Versus Open Resection

PROVIDER: 2454989 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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: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: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.

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A La CaRT: Australasian Laparoscopic Cancer of the Rectum TrialA phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer

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