A Randomized Controlled Study of Prophylactic Stoma in Unresected Peritoneal Metastasis of Colorectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 48170 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:BackgroundClosure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site.MethodsIn this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964.FindingsBetween Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43-0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26-0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60-1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54-1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events.InterpretationReinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias.FundingNational Institute for Health Research Research for Patient Benefit and Allergan.
| S-EPMC7016509 | biostudies-literature
Project description:Interventions: ICG-AI Group:Quantification of intestinal blood supply by ICG combined with AI;Traditional Group:None
Primary outcome(s): Preventive stoma rate
Study Design: Parallel
| 88860 | ecrin-mdr-crc
Project description:In this open-label randomized controlled phase I/II trial, 20 stable peritoneal dialysis patients underwent two 4 h dwells with acidic glucose-based PDF, with and without 8 mM alanyl-glutamine (AlaGln) in a cross-over design. Unsupervised hierarchical clustering of transcriptomics data suggested specific effects of AlaGln in patients who had previously suffered from peritonitis.
2020-01-24 | GSE57070 | GEO
Project description:BACKGROUND:Peritoneal metastasis is the most frequent failure in gastric cancer. This study evaluated the role of prophylactic chemotherapeutic hyperthermic intraperitoneal perfusion (CHIP) in patients after D2 dissection. METHODS:Gastric cancer patients after D2 dissection were enrolled in this study. Patients received either chemotherapy (IV group) or CHIP (CHIP group). Sites of recurrence or metastasis, disease-free survival (DFS), overall survival (OS) and adverse events were evaluated. RESULTS:Twenty-two patients received CHIP treatment, and 21 patients received chemotherapy alone. The median DFS time was 24.5 and 36.5?months in the IV group and CHIP group (P?=?0.044), respectively. The median OS time was 33.1?months in the IV group and not reached in the CHIP group (P?=?0.037). We also found that CHIP could reduce the total recurrence/metastasis rate, especially that of peritoneal metastasis. In the subgroup analysis, DFS and OS were both superior in deficient mismatch repair (dMMR) patients than in proficient MMR (pMMR) patients. CONCLUSION:This hypothesis-generating study indicates that CHIP might be feasible for gastric cancer patients after D2 resection.
| S-EPMC7461269 | biostudies-literature
Project description:Purpose: Decitabine is a deoxycytidine nucleoside derivative inhibitor of DNA-methyltransferases indicated for treatment of myelodysplastic syndrome (MDS). Laboratory evidence shows that pretreatment of AML cell lines can sensitize leukemia cells to chemotherapy and inhibit clonogenic potential. We conducted a randomized study of decitabine when used as priming before standard induction therapy in children with newly diagnosed acute myelogenous leukemia (AML) to evaluate the safety, pharmacokinetics, and any potential early efficacy signal. Exploratory analyses of genomic methylation and RNA expression patterns and minimal residual disease (MRD) were included to elucidate possible biological mechanisms. Methods: This multicenter, randomized, two-arm, open-label study enrolled children ages 1-16 with newly diagnosed de novo AML to either Arm A: daunorubicin, cytarabine, etoposide preceded by a 5-day course of decitabine (experimental arm) or Arm B: daunorubicin, cytarabine, etoposide (control). Following completion of induction therapy, subsequent post-induction treatment was given at the treating physician’s discretion. Patients were monitored for adverse events and samples were collected for PK/PD and biologic analyses. Results: Twenty patients, ages 1-16 years (median 9.4 yrs in both Arms) were treated (10 per Arm). Eighteen of 20 enrolled subjects completed the prescribed treatment. All subjects experienced neutropenia and thrombocytopenia as is expected during AML induction chemotherapy. The most common grade 3 and 4 non-hematologic adverse events observed were caecitis, 2 (20%) subjects in Arm A and 0 (0%) subjects in Arm B; decreased appetite, 3 (30%) subjects in Arm A and 0 (0%) subjects in Arm B; and hypophosphatemia, 2 (20%) subjects in Arm A and 0 (0%) subjects in arm B. One subject in Arm A had appendicitis and colon perforation on Day 6 that led to study discontinuation; the cause was later determined to have been leukemic infiltrate of the bowel wall. Two subjects died (both in Arm A), one of necrotic bowel, pseudomonas sepsis and multisystem organ failure 6 months after study participation and one patient 5 months following study treatment from multisystem organ failure as a complication of stem cell transplant. Plasma concentrations of decitabine showed PK values (mean+SD) of Cmax, 281+113 ng/mL, AUC0-∞, 198+65.3 ng*h/mL, CL, 156+94.6 L/h, Vdss 109+70 L, t1/2 0.48+0.060 h, and median tmax 0.93 h. Overall CR/CRi by morphology was similar between the two treatment arms (92% for the control arm and 100% for the experimental arm). MRD at Day 30 post induction therapy was lower in the control group compared to the decitabine group (67% vs 85% MRD-negative). Changes in DNA epigenetic and RNA expression patterns demonstrated distinct differences involving selective cellular pathways between the two groups of patients comparing diagnostic to day 30 bone marrow samples. Conclusions: This first-in-pediatric trial of epigenetic priming in patients with newly diagnosed AML demonstrates that decitabine pre-treatment followed by standard combination chemotherapy is well tolerated in children with newly diagnosed AML. Morphologic complete responses were similar in both treatment arms. MRD at Day 30 following induction therapy suggests a deeper remission in patients receiving decitabine. No differences were observed between treatment arms in hematologic toxicities although decitabine-treated patients were noted to have more gastrointestinal toxicities, anorexia and hypophosphatemia. Decitabine PK parameters in children were consistent with known adult PK profiles. Molecular changes associated with decitabine pretreatment may be important in the sensitization of clonogenic AML cells. Pre-treatment with decitabine may represent a therapeutic option for use in pediatric AML, when epigenetic modification is a desired focus for treatment.
2017-10-31 | GSE78963 | GEO
Project description:Background and study aims
Ileostomy is a procedure where the small intestine is diverted to an opening in the abdomen. The waste products are collected through an opening called a stoma in the tummy. With the loss of an important body function and a distortion in body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients make a smooth transition to living with their stoma. Limited studies have tested psychosocial interventions (methods) on the improvement of patients stoma-related health concerns. The aim is to find out if a psychosocial intervention leads to a significant reduction in days to stoma proficiency, length of hospital stay, anxiety and depression, as well as improvement in their ability to care for themselves, acceptance of the stoma, and quality of life for patients with a newly formed stoma.
Who can participate?
Patients undergoing elective colorectal resections who require formation of a permanent stoma.
What does the study involve?
Eligible patients will be randomly allocated to either a control group or an intervention group. Patients in the control group will receive routine care, where they will receive education on care of stoma after the operation. Patients in the intervention group will receive the STOMA psychosocial intervention programme in addition to routine care. The STOMA psychosocial intervention programme includes an individual psychoeducation face-to-face session (before the operation) with a booklet provided, and five telephone follow-up sessions (one before the operation and four after).
| 2417289 | ecrin-mdr-crc
Project description:Stoma-reversal surgery is associated with high postoperative morbidity, including wound complications and surgical-site infections (SSIs). This study aims to assess whether the application of negative-pressure wound therapy (NPWT) can improve wound healing compared with conventional wound dressing. This was a single-centre, superiority, open-label, parallel, individually randomized controlled trial. Patients undergoing stoma reversal were randomized (1 : 1) to receive NPWT or conventional wound dressing. The primary endpoint of the study was the rate of wound complications and SSIs after stoma closure. The secondary endpoints were postoperative wound pain, rate of wound healing after 30 days from stoma closure, and wound aesthetic satisfaction. Between June 2019 and January 2021, 50 patients were allocated to the NPWT group (all received NPWT, 49 were analysed); 50 patients were allocated to the conventional wound dressing group (48 received the treatment, 45 were analysed). No significant difference was found in wound-complication rate (10 per cent NPWT versus 16 per cent controls; odds ratio 0.61 (95 per cent c.i. 0.18 to 2.10), P = 0.542) and incisional SSI rate (8 per cent NPWT versus 7 per cent controls; odds ratio 1.24 (95 per cent c.i. 0.26 to 5.99), P = 1.000). The NPWT group showed less pain, higher aesthetic satisfaction (P < 0.0001), and a higher proportion of wound healing (92 versus 78 per cent; P = 0.081) compared with the control group. NPWT does not reduce the incidence of SSI after stoma-reversal surgery compared with conventional wound dressing. However, NPWT improved the healing of uninfected wounds, reduced wound pain and led to better aesthetic outcomes.Registration number: NCT037812016 (clinicaltrials.gov).
| S-EPMC8669787 | biostudies-literature
Project description:IntroductionApplication of a prophylactic mesh during stoma closure was shown to reduce the incidence of incisional hernia at the site of stoma closure. Our objective is to provide high quality evidence to validate this finding.Methods and analysisThe study will be a randomised controlled triple-blinded superiority parallel monocentric trial. Patients undergoing elective ileostomy or colostomy closure after surgery for digestive cancer will be eligible for inclusion. Patients allergic to the mesh, immunosuppressed or refusing to participate will be excluded. Randomisation will be performed based on a 1:1 allocation ratio between stoma closure with application of a non-absorbable mesh in the sublay position (intervention) and stoma closure without a mesh (control). The primary outcome will be the 1-year incidence of incisional hernia at the site of stoma closure, determined clinically and by CT. Secondary outcomes will be the 31-day incidence of surgical site infection and the modified Carolinas Comfort Scale. Patients, radiologists and investigators performing the assessment at 1 year will be blinded for the allocated study group. Analysis will be performed in intention-to-treat. The trial will include 68 patients (34 with mesh, 34 without mesh).Ethics and disseminationThe present randomised controlled trial was registered into clinicaltrials.gov (NCT04510558) and was accepted by the local ethic committee (Geneva, Switzerland: CCER 2021-00053). The results will be presented at national and international congresses in the fields of colorectal surgery and general surgery, and published in a peer-reviewed journal.
| S-EPMC8671978 | biostudies-literature
Project description:BACKGROUND:The construction of a colostomy is a common procedure, but the evidence for the different parts of the construction of the colostomy is lacking. Parastomal hernia is a common complication of colostomy formation. The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation (one including a mesh) regarding the development of parastomal hernia. METHODS/DESIGN:Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation. The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year. Secondary endpoints are re-admission rate, postoperative complications (classified according to Clavien-Dindo), stoma-related complications (registered in the case record form at stoma care nurse follow-up), total length of hospital stay during 12 months, health-related quality of life and health economic analysis as well as re-operation rate and mortality within 30 days and 12 months of primary surgery. Follow-up is scheduled at 4-6 weeks, and 6 and 12 months. Inclusion is set at 240 patients. DISCUSSION:Parastomal hernia is a common complication after colostomy formation. Several studies have been performed with the aim to reduce the rate of this complication. However, none are fully conclusive and data on quality of life and health economy are lacking. The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01694238.2012-09-24.
| S-EPMC4094442 | biostudies-literature
Project description:The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.
| 2747621 | ecrin-mdr-crc