Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery -Multicenter, randomized, single blind, parallel-group comparison study-
Ontology highlight
ABSTRACT:
DISEASE(S): Rectal Cancer
PROVIDER: 2649401 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.
Eligible patients will be randomly assigned to one of 2 arms:
* Seprafilm group (receiving resorbable barrier membrane during the first surgery)
* No-treatment control group (without seprafilm barrier during the first surgery)
The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.
This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.
A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.
| 2099716 | ecrin-mdr-crc
Project description:IntroductionIn closure of a stoma, the small working space and adhesions hinder a precise surgical procedure, compared with conventional approaches to digestive surgery. The aim of this prospective study was to introduce a new technique of laparoscopic stoma closure (LASC).Materials and surgical techniquesAfter starting with three trocars, it is a priority to dissect around the arising ileum; a linear stapler is precisely inserted in both orifices of the loop stoma and applied two times, extracorporeally. Ultimately, both the oral and anal sides of the loop ileum are cut and closed using a linear cutter stapler in a delta-shaped manner just under the abdominal wall, intracorporeally. Eventually, the arising stoma is removed using an intra-abdominal and cutaneous approach.DiscussionLASC for patients with a temporary loop ileostomy is safe and feasible. More data and experience will be required to verify the benefits of this new technique.
| S-EPMC7687255 | biostudies-literature
Project description:ObjectiveThe objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal).BackgroundReversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7-9% and minor complications varying from 4-5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality.Design and methodsEarly closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0-12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation).DiscussionThe aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637.
| S-EPMC3191573 | biostudies-literature
Project description:ObjectiveThe aim of this study was to compare ghost ileostomy (GI) and loop ileostomy (LI) in patients undergoing oncologic resection for rectal cancer in terms of postoperative morbidity.Summary background dataLIs are often fashioned to protect downstream anastomoses following oncologic resection for low rectal cancer at medium-to-high risk of anastomotic leak. More recently, GIs have been utilized in patients with low-to-medium risk anastomoses to reduce the rate of unnecessary stomas.MethodsMedline, Embase, and CENTRAL were systematically searched. Studies investigating the use of GI in patients undergoing oncologic resection for rectal cancer were included. The primary outcomes were anastomotic leak and postoperative morbidity. Secondary outcomes included stoma-related complications and length of stay (LOS). Pairwise meta-analyses were performed with inverse variance random effects.ResultsFrom 242 citations, 14 studies with 946 patients were included. In comparative studies, 359 patients were undergoing GI and 266 patients were undergoing LI. Pairwise meta-analysis revealed no differences in the prevalence of anastomotic leak (OR 1.40, 95%CI .73-2.68, P = .31), morbidity (OR .76, 95%CI .44-1.30, P = .32), or LOS (SMD -.05, 95%CI -.33-.23, P = .72). International Study Group of Rectal Cancer anastomotic leak grades were as follows: Grade A (GI 0% vs LI 13.3%), Grade B (GI 80.9% vs LI 86.7%), Grade C (GI 19.1% vs LI 0%).ConclusionsGI appears to be a safe alternative to LI following oncologic resection for rectal cancer. Larger, prospective comparative studies are warranted to evaluate the use of GI in patients deemed to be at low-to-medium risk of anastomotic leak.
| S-EPMC10403968 | biostudies-literature
Project description:BackgroundThe right internal jugular vein is currently recommended for temporary central dialysis catheters (tCDC) based on results from previous studies showing a lower incidence of central vein stenosis compared to the subclavian vein. Data is however conflicting, and there are several advantages when the subclavian route is used for tCDCs. This prospective, controlled, randomised, non-inferiority study aims to compare the incidence of post-catheterisation central vein stenosis between the right subclavian and the right internal jugular routes.MethodsAdult patients needing a tCDC will be included from several hospitals and randomised to either subclavian or internal jugular vein catheterisation with a silicone tCDC. Inclusion continues until 50 patients in each group have undergone a follow-up CT venography. The primary outcome is the incidence of post-catheterisation central vein stenosis detected by a CT venography performed 1.5 to 3 months after removal of the tCDC. Secondary outcomes include between-group comparisons of (I) the patients' experience of discomfort and pain, (II) any dysfunction of the tCDC during use, (III) catheterisation success rate and (IV) the number of mechanical complications. Furthermore, the ability to detect central vein stenosis by a focused ultrasound examination will be evaluated using the CT venography as golden standard.DiscussionThe use of the subclavian route for tCDC placement has largely been abandoned due to older studies with various methodological issues. However, the subclavian route offers several advantages for the patient. This trial is designed to provide robust data on the incidence of central vein stenosis after silicone tCDC insertion in the era of ultrasound-guided catheterisations.Trial registrationClinicaltrials.gov; NCT04871568. Prospectively registered on May 4, 2021.
| S-EPMC10176902 | biostudies-literature
Project description:Introduction:A Loop ileostomy is one of the most common techniques used in colorectal surgery to establish a reversible faecal diversion and bypass the large bowels, in order to protect either a downstream colorectal anastomosis or a coloanal anastomosis. However, it is a procedure that can cause a plethora of complications including long term ones such as the psychological effects. Currently, there is no consensus regarding the optimal time to perform closure of a loop ileostomy. Some studies suggested the early reversal of ileostomy procedure as a solution to reduce these complications. This study aims to review the available literature in order to ascertain the benefits behind early closure of loop ileostomy. Methods:The literature was searched for all studies that included a comparison between the outcomes of early and late closure of loop ileostomy in terms of morbidity, mortality, or quality of life, where available. Early closure of loop ileostomy is defined as closure less than three months and late as more than three months, in accordance with conventional literature. The resultant articles were filtered using our inclusion and exclusion criteria. Finally, the remaining articles were assessed for quality and their results were compared to one another in order to draw our conclusions. Results and Discussion. The results were slightly inclined toward early closure of loop ileostomy. However, there were limitations of the studies reviewed, including the heterogenicity of studies, selection bias, lack of clear definition of measured outcomes, and small sample size. Taking that into consideration, the results of early closure of loop ileostomies in the selected patients were promising and require further investigation.
| S-EPMC7481925 | biostudies-literature
Project description:Loop ileostomy is an effective procedure to protect downstream intestinal anastomoses. Ileostomy reversal surgery is often performed within 12 months of formation but is associated with substantial morbidity due to severe post-surgical complications. Distal ileum is deprived of enteral nutrition and rendered inactive, often becoming atrophied and fibrotic. This study aimed to investigate the microbial and morphological changes that occur in the defunctioned ileum following loop ileostomy-mediated fecal stream diversion. Functional and defunctioned ileal resection tissue was obtained at the time of loop-ileostomy closure. Intrapatient comparisons, including histological assessment of morphology and epithelial cell proliferation, were performed on paired samples using the functional limb as control. Mucosal-associated microflora was quantified via determination of 16S rRNA gene copy number using qPCR analysis. DGGE with Sanger sequencing and qPCR methods profiled microflora to genus and phylum level, respectively. Reduced villous height and proliferation confirmed atrophy of the defunctioned ileum. DGGE analysis revealed that the microflora within defunctioned ileum is less diverse and convergence between defunctioned microbiota profiles was observed. Candidate Genera, notably Clostridia and Streptococcus, reduced in relative terms in defunctioned ileum. We conclude that Ileostomy-associated nutrient deprivation results in dysbiosis and impaired intestinal renewal in the defunctioned ileum. Altered host-microbial interactions at the mucosal surface likely contribute to the deterioration in homeostasis and thus may underpin numerous postoperative complications. Strategies to sustain the microflora before reanastomosis should be investigated.
| S-EPMC5628638 | biostudies-literature
Project description:Primary outcome(s): The incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
| 2655699 | ecrin-mdr-crc
Project description:BackgroundLow anterior resection syndrome (LARS) has a significant impact on postoperative quality of life. Although early closure of an ileostomy is safe in selected patients, functional outcomes have not been investigated. The aim was to compare bowel function and the prevalence of LARS in patients who underwent early or late closure of an ileostomy after rectal resection for cancer.MethodsEarly closure (8-13 days) was compared with late closure (after 12 weeks) of the ileostomy following rectal cancer surgery in a multicentre RCT. Exclusion criteria were: signs of anastomotic leakage, diabetes mellitus, steroid treatment and postoperative complications. Bowel function was evaluated using the LARS score and the Memorial Sloan Kettering Cancer Center Bowel Function Instrument (BFI).ResultsFollowing index surgery, 112 participants were randomized (55 early closure, 57 late closure). Bowel function was evaluated at a median of 49 months after stoma closure. Eighty-two of 93 eligible participants responded (12 had died and 7 had a permanent stoma). Rates of bowel dysfunction were higher in the late closure group, but this did not reach statistical significance (major LARS in 29 of 40 participants in late group and 25 of 42 in early group, P = 0·250; median BFI score 63 versus 71 respectively, P = 0·207). Participants in the late closure group had worse scores on the urgency/soiling subscale of the BFI (14 versus 17; P = 0·017). One participant in the early group and six in the late group had a permanent stoma (P = 0·054).ConclusionPatients undergoing early stoma closure had fewer problems with soiling and fewer had a permanent stoma, although reduced LARS was not demonstrated in this cohort. Dedicated prospective studies are required to evaluate definitively the association between temporary ileostomy, LARS and timing of closure.
| S-EPMC6590150 | biostudies-literature
Project description:ObjectiveNeoadjuvant chemotherapy for advanced ovarian cancer is associated with reduced morbidity in the elderly (Meyer et al., 2018). Spontaneous colonic perforation often leads to multisystem organ failure and death (Carter and Durfee, 2007; Rose and Piver, 1995).MethodsA 76-year old woman with stage IIIC disease initiated carboplatin AUC 5 and paclitaxel 175 mg/m2 with unanticipated development of profound neutropenia. She clinically deteriorated by day nine and CT scan revealed a large volume of free air. Emergent surgery was performed.ResultsDiagnostic laparoscopy confirmed the presence of intra-abdominal stool and extensive inflammatory exudate (Video). The likelihood of identifying the site of perforation appeared remote, but pelvic tumor encasement was highly suggestive of a sigmoid origin. The stool was evacuated, the exudate gently debrided and the terminal ileum partially mobilized. Copious irrigation was performed with drain placement and the pneumoperitoneum was decompressed. The right lower abdominal wall trocar incision was extended so that the ileal segment could be brought out and matured. She was discharged to rehab on postoperative day 2 to continue a two week course of broad spectrum antibiotics. Single-agent carboplatin was resumed within a month. Uncomplicated ileostomy takedown with parastomal hernia repair was performed between cycles five and six. The patient is currently in remission.ConclusionBowel perforation in the elderly, presenting with cachexia and treatment-induced pancytopenia for advanced ovarian cancer, is often a harbinger of early death. Selected patients may benefit from a minimally invasive approach by an experienced gynecologic oncologist instead of vertical laparotomy, abdominal washout, diversion and the potential sequelae of an open abdomen.
| S-EPMC6434062 | biostudies-literature