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"Intestinal surgery"
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Resectability of Small Duodenal Tumors: A Randomized Controlled Trial Comparing Underwater Endoscopic Mucosal Resection and Cold Snare Polypectomy
2024
INTRODUCTION:Underwater endoscopic mucosal resection (UEMR) and cold snare polypectomy (CSP) are novel endoscopic procedures for superficial nonampullary duodenal epithelial tumors (SNADET). However, consensus on how to use both procedures appropriately has not been established. In this study, we evaluated treatment outcomes of both procedures, including resectability.METHODS:In this single-center randomized controlled study conducted between January 2020 and June 2022, patients with SNADET ≤12 mm were randomly allocated to UEMR and CSP groups. The primary end point was sufficient vertical R0 resection (SVR0), which was defined as R0 resection including a sufficient submucosal layer. We compared treatment outcomes including SVR0 rate between groups.RESULTS:The SVR0 rate was significantly higher in the UEMR group than in the CSP group (65.6% vs 41.5%, P = 0.01). By contrast, the R0 resection rate was not significantly different between study groups (70.3% vs 61.5%, P = 0.29). The submucosal layer thickness was significantly greater in the UEMR group than in the CSP group (median 546 [range, 309-833] μm vs 69 [0-295] μm, P < 0.01). CSP had a shorter total procedure time (median 12 [range, 8-16] min vs 1 [1-3] min, P < 0.01) and fewer total bleeding events (9.4% vs 1.5%, P = 0.06).DISCUSSION:UEMR has superior vertical resectability compared with CSP, but CSP has a shorter procedure time and fewer bleeding events. Although CSP is preferable for most small SNADET, UEMR should be selected for lesions that cannot be definitively diagnosed as mucosal low-grade neoplasias.
Journal Article
Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial
by
Govaert, Marc J
,
Groenendijk, R P R
,
Mannaerts, G H H
in
Anastomosis
,
Colon, Sigmoid - surgery
,
Design modifications
2015
Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality.
We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485.
Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54–3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43).
Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis.
Netherlands Organisation for Health Research and Development.
Journal Article
Predictive Factors of Intestinal Necrosis in Acute Mesenteric Ischemia: Prospective Study from an Intestinal Stroke Center
2017
To identify predictive factors for irreversible transmural intestinal necrosis (ITIN) in acute mesenteric ischemia (AMI) and establish a risk score for ITIN.
This single-center prospective cohort study was performed between 2009 and 2015 in patients with AMI. The primary outcome was the occurrence of ITIN, confirmed by specimen analysis in patients who underwent surgery. Patients who recovered from AMI with no need for intestinal resection were considered not to have ITIN. Clinical, biological and radiological data were compared in a Cox regression model.
A total of 67 patients were included. The origin of AMI was arterial, venous, or non-occlusive in 61%, 37%, 2% of cases, respectively. Intestinal resection and ITIN concerned 42% and 34% of patients, respectively. Factors associated with ITIN in multivariate analysis were: organ failure (hazard ratio (HR): 3.1 (95% confidence interval (CI): 1.1-8.5); P=0.03), serum lactate levels >2 mmol/l (HR: 4.1 (95% CI: 1.4-11.5); P=0.01), and bowel loop dilation on computerized tomography scan (HR: 2.6 (95% CI: 1.2-5.7); P=0.02). ITIN rate increased from 3% to 38%, 89%, and 100% in patients with 0, 1, 2, and 3 factors, respectively. Area under the receiver operating characteristics curve for the diagnosis of ITIN was 0.936 (95% CI: 0.866-0.997) depending on the number of predictive factors.
We identified three predictive factors for irreversible intestinal ischemic injury requiring resection in the setting of AMI. Close monitoring of these factors could help avoid unnecessary laparotomy, prevent resection, as well as complications due to unresected necrosis, and possibly lower the overall mortality.
Journal Article
Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial)
by
Borghi, Felice
,
Bonino, Marco Augusto
,
Bannone, Elisa
in
Abdominal Surgery
,
Acute Disease
,
Adult
2017
Background
The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction.
Methods
This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery.
Results
Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS
n
= 56, ES
n
= 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (
p
= 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (
p
= 0.998) and progression-free survival rates between the groups has been observed (
p
= 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (
p
= 0.031), with a reversal rate of 30% so far.
Conclusions
Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands.
Journal Article
Laparoscopic treatment of intestinal malrotation in neonates and infants: retrospective study
by
Hagendoorn, Jeroen
,
Vieira-Travassos, Daisy
,
van der Zee, David
in
Abdominal Surgery
,
Adolescent
,
Appendectomy
2011
Background
Intestinal malrotation in neonates or infants may require urgent surgical treatment, especially when volvulus and vascular compromise of the midgut are suspected. Successful laparoscopic management of malrotation has been described in a number of case reports. It remains unclear, however, whether laparoscopy for the treatment of malrotation has a success rate equal to that of open surgery and what relative risks exist in terms of conversion and redo surgery in larger numbers of patients. This report describes a retrospective analysis of the clinical outcome for 45 children who underwent laparoscopic treatment of intestinal malrotation at the authors’ institution.
Methods
The 45 patients in this series, ages several days to 13 years, underwent a diagnostic laparoscopy for suspected intestinal malrotation. For 37 patients, malrotation with or without volvulus was diagnosed. All these patients underwent laparoscopic derotation and Ladd’s procedure.
Results
Successful laparoscopic treatment of intestinal malrotation could be performed in 75% of the cases (
n
= 28), and conversion to an open procedure was necessary in 25% of the cases (
n
= 9). The median hospital stay was 11 days (range, 2–60 days). Postoperative clinical relapse due to recurrence of malrotation, volvulus, or both occurred for 19% of the laparoscopically treated patients (
n
= 7). These patients underwent laparoscopic (
n
= 1) or open (
n
= 6) redo surgery.
Conclusion
Diagnostic laparoscopy is the procedure of choice when intestinal malrotation is suspected. If present, malrotation can be treated adequately with laparoscopic surgery in the majority of cases. Nevertheless, to prevent recurrence of malrotation or volvulus, a low threshold for conversion to an open procedure is mandated.
Journal Article
Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial
2016
Small bowel obstruction due to internal hernia is a common and potentially serious complication after laparoscopic gastric bypass surgery. Whether closure of surgically created mesenteric defects might reduce the incidence is unknown, so we did a large randomised trial to investigate.
This study was a multicentre, randomised trial with a two-arm, parallel design done at 12 centres for bariatric surgery in Sweden. Patients planned for laparoscopic gastric bypass surgery at any of the participating centres were offered inclusion. During the operation, a concealed envelope was opened and the patient was randomly assigned to either closure of mesenteric defects beneath the jejunojejunostomy and at Petersen's space or non-closure. After surgery, assignment was open label. The main outcomes were reoperation for small bowel obstruction and severe postoperative complications. Outcome data and safety were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01137201.
Between May 1, 2010, and Nov 14, 2011, 2507 patients were recruited to the study and randomly assigned to closure of the mesenteric defects (n=1259) or non-closure (n=1248). 2503 (99·8%) patients had follow-up for severe postoperative complications at day 30 and 2482 (99·0%) patients had follow-up for reoperation due to small bowel obstruction at 25 months. At 3 years after surgery, the cumulative incidence of reoperation because of small bowel obstruction was significantly reduced in the closure group (cumulative probability 0·055 for closure vs 0·102 for non-closure, hazard ratio 0·56, 95% CI 0·41–0·76, p=0·0002). Closure of mesenteric defects increased the risk for severe postoperative complications (54 [4·3%] for closure vs 35 [2·8%] for non-closure, odds ratio 1·55, 95% CI 1·01–2·39, p=0·044), mainly because of kinking of the jejunojejunostomy.
The results of our study support the routine closure of the mesenteric defects in laparoscopic gastric bypass surgery. However, closure of the mesenteric defects might be associated with increased risk of early small bowel obstruction caused by kinking of the jejunojejunostomy.
Örebro County Council, Stockholm City Council, and the Erling-Persson Family Foundation.
Journal Article
Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Double-Biopsy Technique for Removal of Diminutive Colorectal Polyps: A Prospective Randomized Study
by
Jang, Jae Young
,
Lee, Chang Kyun
,
Shim, Jae-Jun
in
Adenoma - pathology
,
Adenoma - surgery
,
Adult
2013
There are few data on cold snare polypectomy (CSP) in direct comparison with cold forceps polypectomy (CFP) for colonoscopic resection of diminutive colorectal polyps (DCPs; ≤5 mm). The primary aim of this study was to compare the histologic polyp eradication rate of CSP with that of CFP using double-biopsy technique.
This was a randomized controlled trial at a single academic hospital. Of the 165 patients invited, 54 consecutive patients having 117 eligible polyps were enrolled in this study. To evaluate histologic eradication of polyps, two or more additional biopsies were taken from the base and edges of the polypectomy site.
The mean size of polyps was 3.66 mm (±1.13). Most polyps evaluated were tubular adenomas (69.9%). The rate of histologic eradication was significantly higher in the CSP group than in the CFP group (93.2% vs. 75.9%, P=0.009). The time taken for polypectomy was significantly shorter in the CSP group (14.29 vs. 22.03 s, P<0.001). Failure of tissue retrieval was noted in 6.8% of polyps resected by CSP. Multivariate analysis revealed that the method of polypectomy (CFP) and the polyp size (≥4 mm) were independent predictors associated with incomplete histologic eradication (odds ratio (OR) 4.750 (95% confidence interval (CI): 1.459-15.466), OR 4.375 (95% CI: 1.345-14.235); all P<0.05, respectively).
CSP is superior to CFP for the endoscopic removal of DCPs with regard to completeness of polypectomy. CSP technique should be considered the primary method for endoscopic treatment of polyps in the 4-5-mm size range (ClinicalTrials.gov number: NCT01646242).
Journal Article
Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial
2022
ObjectiveHydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D).DesignEligible patients (haemoglobin A1c (HbA1c) 59–86 mmol/mol, body mass index≥24 and ≤40 kg/m2, fasting insulin >48.6 pmol/L, ≥1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks.ResultsOverall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was −10.4 (18.6) mmol/mol in DMR group versus −7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was −5.4 (5.6)% in DMR group versus −2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was –6.6 mmol/mol (17.5 mmol/mol) versus –3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was –5.4% (6.1%) versus –2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient.ConclusionsDMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG.Trial registration numberNCT02879383
Journal Article
Local Recurrence After Endoscopic Resection for Large Colorectal Neoplasia: A Multicenter Prospective Study in Japan
by
Hisabe, Takashi
,
Tsuruta, Osamu
,
Kobayashi, Kiyonori
in
Aged
,
Carcinoma - pathology
,
Carcinoma - surgery
2015
Conventional endoscopic resection (CER) is a widely accepted treatment for early colorectal neoplasia; however, large colorectal neoplasias remain problematic, as they necessitate piecemeal resection, increasing the risk of local recurrence. Endoscopic submucosal dissection (ESD) can improve the en bloc resection rate. This study aimed to evaluate local recurrence and its associated risk factors after endoscopic resection (ER) for colorectal neoplasias ≥20 mm.
A multicenter prospective study at 18 medium- and high-volume specialized institutions was conducted in Japan. Follow-up colonoscopy was performed after 12 months in cases of complete resection and after 3-6 months in cases of incomplete resection. Local recurrence was confirmed by endoscopic findings and/or pathological analysis.
Follow-up colonoscopy was performed in 1,524 of 1,845 enrolled colorectal neoplasias (mean age, 65 years; 885 men; median tumor size, 32.8 mm). The local recurrence rates were 4.3% (65/1,524), 6.8% (55/808), and 1.4% (10/716) for the entire cohort, for CER, and for ESD, respectively. The relative risks of local recurrence were 0.21 (95% confidence interval, 0.11-0.39) with ESD compared with CER, 0.32 (95% confidence interval, 0.11-0.92) with en bloc ESD compared with en bloc CER, and 0.90 (95% confidence interval, 0.39-2.12) with piecemeal ESD compared with piecemeal CER. Significant factors associated with local recurrence were piecemeal resection, laterally spreading tumors of granular type, tumor size ≥40 mm, no pre-treatment magnification, and ≤10 years of experience in CER, and piecemeal resection only in ESD.
En bloc ESD reduces the local recurrence rate for large colorectal neoplasias. Piecemeal resection is the most important risk factor for local recurrence regardless of the ER method used.
Journal Article
Endoscopic mucosal resection in high- and low-volume centers: a prospective multicentric study
by
Viale, E.
,
Crosta, C.
,
Della Giustina, F.
in
Abdominal Surgery
,
Adenocarcinoma - surgery
,
Adenoma - surgery
2013
Background
Endoscopic mucosal resection (EMR) is an effective therapeutic technique well-standardized worldwide for the treatment of gastrointestinal neoplasm limited to the mucosal layer. To date, no study has compared technical and clinical differences based on the number of EMRs performed per year. This study aimed to compare EMR technical success, complications, and clinical outcome between low-volume centers (LVCs) and high-volume centers (HVCs). A total of nine endoscopic centers were included in the study.
Methods
This prospective study investigated consecutive patients with sessile polyps or flat colorectal lesions 1 cm or larger referred for EMR.
Results
A total of 427 lesions were resected in 384 patients at nine endoscopic centers. Males accounted for 60.4 % and females for 39.6 % of the patients. Most of the EMRs (84.8 %) were performed in HVCs and only 15.2 % in LVCs. All the lesions were resected in only one session. Argon plasma coagulation was performed on the margins of piecemeal resection in 15.7 % of the patients in HVCs only. Complete excision was achieved for 98.6 % of the lesions in HVCs and 98.8 % of the lesions in LVCs. The complication rate was 4.4 % in HVCs and 4.6 % in LVCs (
p
= 0.94). Delayed bleeding occurred in 2.5 % of the HVC cases and 3.1 % of the LVC cases. Perforation occurred in 1.9 % of the HVC cases and 1.5 % of the LVC cases (
p
= 1.00). Recurrences were experienced with 15 % of the lesions: 15.5 % in HVCs and 14 % in LVCs (
p
= 0.79).
Conclusions
The study showed that EMR can be performed also in LVC.
Journal Article