Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort
Ontology highlight
ABSTRACT:
DISEASE(S): Intestinal Diseases,Low Anterior Resection Syndrome,Rectal Cancer
PROVIDER: 2354860 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: Group 1: Evaluation of the LARS score in patients undergoing debulking surgery for ovarian cancer who underwent sigma / rectosigmoid or deep anterior rectal resection.
The control cohort will be:
1) Ovarian cancer patients who underwent debulking surgery without sigma/rectum resection;
2) breast cancer patients (matched-pair) who have neo / adjuvant chemotherapy based on their diagnosis but no history of abdominal/bowel surgery.
Primary outcome(s): The aim of the present study is to evaluate the prevalence of the low anterior resection syndrome (LARS) in patients with advanced epithelial ovarian cancer..
Study Design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
| 2435021 | ecrin-mdr-crc
Project description:TITLE:
"Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ".
DESIGN:
Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio.
POPULATION:
Patients undergoing colorectal cancer surgery a definitive end colostomy.
OBJECTIVES:
The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery.
Secondary objectives are:
1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery.
2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.
4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale).
DESCRIPTION OF THE INTERVENTION:
An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia.
DURATION OF THE STUDY:
The expected duration of the study is 3 years.
PATIENT FOLLOW UP TIME:
The planned follow-up time is 2 years.
EXPECTED RECRUITMENT TIME:
12 months.
| 2339952 | ecrin-mdr-crc
Project description:Oncological rectal cancer outcomes have improved considerably because of optimal surgery by total mesorectal excision in conjunction with multidisciplinary team management by selective multimodal therapy (ie, neo-adjuvant chemo-radiotherapy). The 5-year survival has increased to more than 50% and local recurrence has been reduced to less than 10%. These advancements have resulted in more patient receiving sphincter-preserving surgery (SPS). With an increasing number of rectal cancer survivors, the investigators observe a rising attention to the disordered bowel function after SPS, called "low anterior resection syndrome" (LARS). LARS appear immediately after surgery, becoming most pronounced during the first few months, and improved thereafter, reaching a steady state after around two years. However, up to 60% of patients with SPS suffer from LARS which impaired their quality of life (QoL). The prevalence and severity of LARS is difficult to assess due to heterogeneity of the assessment tools. A group of Danish authors have recently developed and validated a five-item instruments for evaluation of LARS (LARS score). It represents to date the best questionnaire to capture anorectal postoperative function and consists of five items: incontinence for flatus, incontinence for liquid stool, frequency of bowel movements, clustering of stools, and urgency. It allows a categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). Developed in Danish, it is now internationally validated with translations in Chinese, English, German, Spanish and Swedish. To our knowledge, French version of the LARS score is not yet available. The aim of our study will be to adapt the LARS scale questionnaire to the French language (LARS-F), and assess its psychometric properties.
Inclusion criteria will be patients 18 years old or above who were operated for rectal cancer from 2007 to 2015. Exclusion criteria will include the presence of stoma and/or known disseminated or recurrent disease. Patients will be identified through local databases by the local investigators at each of the participating centers with a minimum duration of 24 months after surgery to allow their bowel function to have regained stability. This study will be supported by the French Research Group of Rectal Cancer Surgery in order to allow the feasibility of the project.
After translation/back-translation procedures in accordance with the permission from the original authors, the LARS-F score and the whole translation process will be then sent to the original authors for approval. Then a pilot study will be conducted. The French questionnaire (LARS-F score) will be then administered to 100 patients in order to verify the adequacy and degree of comprehension of the questions. Reproducibility will be investigated by a test-retest procedure. A randomly selected subgroup of participants (n= 400) will be sent the LARS-F score questionnaire twice (with an interval of two weeks). The test-retest reliability of the questionnaire will be assessed by the Cohen’s Kappa (no, minor and major LARS scores) or by intra-class correlation coefficient, ICC (quantitative LARS score). Then, eligible patients will receive a postal invitation to complete the LARS-F score and the l’European Organization for Research and treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. The validity of the LARS-F score will be tested by using the indicators of convergent validity and discriminant validity. The convergent validity will be determined notably in this study by computing the correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains. For discriminant validity testing, the investigators will use known variables to affect bowel function after SPS, such as gender, age, neo-adjuvant radiation therapy, distance of the tumor from the anal verge, prior temporary stoma, and length of postoperative period.
The validation of the French version of the LARS score will allow to use a scientific instrument in order to assess both prevalence and severity of LARS. This instrument will allow to develop a future research and clinical practice in France. It will be used in the daily clinical practice to identify patients with LARS score. It will hopefully lead to improve the awareness of clinicians, in order to improve the prevention and the treatment of bowel dysfunction, as well as the information given to patients. In the future, the investigators will able to develop a new patient-led follow-up program based on symptom burden and health-related QoL.
| 2276331 | ecrin-mdr-crc
Project description:Intervention1: LARS score: All patients who undergo had undergone low anterior resection for rectal cancer in Regional Cancer, one year before will be interviewed by a trained interviewer twice at 3-6 months interval using Wexner Incontinence Score 2.LARS Malayalam Questionnaire
3.EORTC QLQ C30 and CR 29 Malayalam translations for measuring QOL.
Primary outcome(s): Incidence of LARS syndrome in patients undergoing low anterior resection for rectal cancer.Timepoint: Post surgery, 3 months and 6 months post op.
| 2595345 | ecrin-mdr-crc
Project description:The purpose of this study is to develop a new severity scoring tool for Low Anterior Resection Syndrome (LARS) drawing on the international consensus criteria for LARS as well as opinions of patients with lived-experience of LARS.
| 2753375 | ecrin-mdr-crc
Project description:Bowel dysfunction after rectal cancer treatment may significantly affect the quality of life. Our study aimed to estimate the incidence and characterize the Low Anterior Resection Syndrome(LARS). We performed a prospective evaluation of patients treated with anterior resection for rectal cancer at two hospitals. Assessment was performed at baseline, after neoadjuvant treatment, and 1, 6 and 12 months after bowel transit reconstruction using the following scores: Bristol scale, LARS score, MSK-BFI, FIQL, EORTC-QLQ30 and a visual analogue scale.
| 2387782 | ecrin-mdr-crc
Project description:Prevalence and severity of allergic diseases have increased worldwide. To date, respiratory allergy phenotypes are not fully characterized and, in addition, the mechanisms underlying sublingual immunotherapy (SLIT) are still unknown. We have used microarrays to understand the underlying mechanisms of SLIT using samples of patients under grass pollen SLIT at different timepoints (T0-before SLIT and T2-two years of treatment, Active or Placebo). We also have taken into account the sensitization of the subjects (Monosensitized patients and Polisensitiez patients)
2020-07-01 | GSE147197 | GEO
Project description:In this study, we identify leucyl-tRNA synthetase (LARS) as a breast tumor suppressor. To identify the mechanism underlying LARS-mediated breast tumor suppression, we first conducted charged tRNA profiling to assess charged and total tRNA-Leu expression in cell lines with high and low LARS expression. Expression of select charged and total tRNA-Leu isoacceptors were reduced in cell lines with lower LARS expression. We then conducted RNA-Seq and translation profiling including ribosome profiling (Ribo-Seq), polysome profiling in LARS-depleted cell lines. To test our hypothesis in vivo, we also performed RNA-Seq of ribosome-associated RNAs in Lars depleted PyMT tumors within RiboTag mice. The analyses implicate LARS as a regulator of leucine-rich translation.
2022-01-05 | GSE176130 | GEO
Project description:An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann’s procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included.
The three groups for randomization are:
A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months.
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2015-11-16 | GSE62851 | GEO