Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Rectal Neoplasms,Colorectal Cancer
PROVIDER: 2059073 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description: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
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Project description:Background:Diversion colitis (DC) is a non-specific inflammation in the intestinal mucosa with colonic dysfunction after low anterior resection of rectal cancer. It is newly proposed in recent years. With the gradual prolongation time of the ileostomy status, the condition of DC may become increasingly severe. However, the corresponding pathogenesis of DC has not been clarified yet. Methods:Clinical information were collected from patients with low rectal cancer admitted to the Department of Anorectal Surgery, Changzheng Hospital, from April 2017 to April 2019. All patients were underwent laparoscopic low anterior resection combined with terminal ileum enterostomy (dual-chamber). After 3-6 months, selective enterostomy closure surgeries were conducted. Retrospective data were divided into mild and severe groups based on the scores of electronic colonoscopy made during follow-up. We then used chi-square test to comparethe clinical baseline information, clinical symptoms, and endoscopic characteristics between the two groups of patients. The multivariate Cox proportional hazards regression model was applied for estimating the odds ratio (OR) and corresponding 95% confidence interval (CI) to identify potential significant factors affecting severity of DC severity. After that, we recruited 40 patients with low rectal cancer after surgery (enterostomy status) and 40 patients were further classified into mild and severe groups according to the scores of endoscopic examinations. The following indexes were tested in the above two groups patients: calprotectin in intestinal lavage fluid, inflammatory factors in tissue and plasma, and lipopolysaccharide levels in plasma. Moreover, 16s-rDNA sequencing was carried out to analyze the diversity and and differences of microbiome in theintestinal lavage fluid of the two groups. Results:According to the endoscopic scores, there were 52 cases in the mild group and 58 cases in the severe group. We found that the age, BMI, history of diabetes , and the incidence of DC-related clinical symptoms (including abdominal pain, mucus, bloody stool, etc.) were significantly different between the two groups. (P＜0.05). Logistic multi-factor regression analysis results showed that age, BMI, history of diabetes, and symptoms associated with the state of the stoma are the independent risk factors that affect DC severity (P＜0.05). After enterostomy closure surgeries, compared with mild group, patients in the severe group showed much more clinical signs, such as abdominal pain, bloody stools, tenesmus, and anal pain andthe daily number of diarrhea, the time to return to normal stool and the level of CRP in plasma were significantly higher (P＜0.05). Results also showed that age, BMI, history of diabetes, and endoscopic scores were the independent risk factors affecting diarrhea severity after enterostomy closure surgery (P＜0.05). Of the 40 patients with low rectal cancer recruited, 23 were in the mild group and 17 in the severe group.In particular, the levels of calprotectin in the intestinal lavage fluid, TNF-α, IL-1β, IL-6 and IL-17 in mucosal /plasma, and the plasma LPS level of severe group were significantly higher than that of mild group (P＜0.05). . The results of 16s-rDNA sequencing showed that micromicrobiome with high enrichment values primarily consisted of Bifidobacteriales and Prevotella in mild group, whereas that in the severe group consisted of Providencia and Dorea. The functional predictions on such two types of microbiome were mainly focused on lipid synthesis, glycan synthesis, metabolism, and amino acid metabolism pathways.
2023-04-04 | GSE226706 | GEO
Project description:RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.
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Project description:We performed whole blood gene expression profiling in 26 patients undergoing laparoscopic surgery for colon cancer stage I-III UICC. Saples were taken the day before surgery (-1), day one postoperatively (+1) and day 10 postoperatively (+10). The aim of the study was to investigate whether gene expression was altered after laparoscopic colon cancer surgery.
2021-11-01 | GSE122626 | GEO
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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Project description:The mechanism of cardiomyocyte prliferation and migration after ventricular resection is a complex and dynamic process. To resolve this, we chose the zebrafish model organism for studying post-injury heart regeneration and wound healing progress via systems biology approach. Transcriptome microarray data and histological analysis of injured fish were sampled at different time points during recovery process. Time-course microarray data following wound healing of zebrafish were obatined. From this set of data, we constructed two intracellular protein–protein interaction (PPI) networks to provide insights into the ventricular resection wound healing mechanism.
2018-04-02 | GSE72348 | GEO
Project description:RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer.
PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.
| 2002892 | ecrin-mdr-crc
Project description:Interventions: Group 1:hand-assisted laparoscopic radical resection of colorectal cancer;Group 2:laparoscopic-assisted radical resection of colorectal cancer;Group 3:robot-assisted radical resection of colorectal cancer
Primary outcome(s): height;weight;Surgical incision length;operation time;Intraoperative blood loss;Number of lymph nodes detected after operation;First exhaust time after surgery;Postoperative hospital stay;Postoperative complication rate;Reoperation rate;Mortality within 30 days after surgery;Intraoperative cost;Local recurrence rate;Disease free survival;Overall survival rate;Postoperative adjuvant chemoradiotherapy rate;First time out of bed after surgery;Time of first postoperative feeding;Time of first urethral catheter extraction after operation;The first time pulling drainage tube after surgery;Tumor staging and typing;Tumor site;Preoperative tumor markers;ASA sizing
Study Design: Parallel
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Project description:Introduction: Circulating microRNAs (miRNAs) exhibit remarkable stability and may serve as biomarkers in several clinical cancer settings. The aim of this study was to investigate changes in the levels of specific circulating miRNA following breast cancer surgery and evaluate whether these alterations were also observed in an independent data set. Methods: Global miRNA analysis was performed on prospectively collected serum samples from 24 post-menopausal women with estrogen receptor-positive early-stage breast cancer before surgery and 3 weeks after tumor resection using global LNA-based quantitative real-time PCR (qPCR). Results: Numbers of specific miRNAs detected in the samples ranged from 142 to 161, with 107 miRNAs detectable in all samples. After correction for multiple comparisons, 3 circulating miRNAs (miR-338-3p, miR-223 and miR-148a) exhibited significantly lower, and 1 miRNA (miR-107) higher levels in post-operative vs. pre-operative samples (p<0.05). No miRNAs were consistently undetectable in the post-operative samples compared to the pre-operative samples. Subsequently, our findings were compared to a dataset from a comparable patient population analyzed using similar study design and the same qPCR profiling platform, resulting in limited agreement. Conclusions: A panel of 4 circulating miRNAs exhibited significantly altered levels following radical resection of primary ER+ breast cancers in post-menopausal women. These specific miRNAs may be involved in tumorigenesis and could potentially be used to monitor whether all cancer cells have been removed at surgery and/or, subsequently, whether the patients develop recurrence.
2014-11-01 | GSE57661 | GEO
Project description:Interventions: experimental group:laparoscopic-assisted resection of colorectal cancer with NOSES techniques;control group:laparoscopic-assisted resection of colorectal cancer
Primary outcome(s): overall survival;disease free survival;local recurrence rate
Study Design: Parallel
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