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Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

ABSTRACT: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield.The Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included.The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy.This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .

SUBMITTER: Straatman J

PROVIDER: S-EPMC4397942 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

Straatman Jennifer J van der Wielen Nicole N Cuesta Miguel A MA Gisbertz Suzanne S SS Hartemink Koen J KJ Alonso Poza Alfredo A Weitz Jürgen J Mateo Vallejo Fransico F Ahktar Khurshid K Diez Del Val Ismael I Roig Garcia Josep J van der Peet Donald L DL

Trials 20150327

<h4>Background</h4>Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the ...[more]

PMID: 25873249

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Project description:ObjectiveMinimally invasive surgery (MIS) techniques are anecdotally reported to be increasingly used, but little objective data supports this. Our objective was to assess trends in MIS utilization across various procedures in pediatric urology and to compare postoperative complication rates between MIS and open procedures.MethodsWe analyzed the 1998-2012 Nationwide Inpatient Sample. We identified children (<18 years old) undergoing open and MIS inpatient procedures and any in-hospital post-operative complications that occurred during that postoperative hospitalization. We utilized propensity score matching and multivariable logistic regression to adjust for confounding factors.ResultsWe identified 163,838 weighted encounters in the "overall cohort," 70,273 of which were at centers performing more than five MIS procedures over the years studied. Use of MIS techniques increased significantly over time for several procedures, most prominently for nephrectomy (Fig.). The overall rate of complications was lower in patients undergoing MIS compared with open surgery (6% vs. 11%, p < 0.001). Specialized centers had a significantly lower overall rate of complications than unspecialized centers (9% vs. 12%, p < 0.001). Within specialized centers, MIS had lower complication rates than open procedures (7% vs. 9%, p < 0.001); this finding was consistent even after adjusting for other factors (OR 0.71, p = 0.02).DiscussionLimitations include that these data may not be generalizable to encounters not in the sample pool. As a large, retrospective, administrative database, NIS may be affected by miscoding bias - rendering our analysis sensitive to the accuracy of procedure coding in NIS. Although the accuracy level of NIS is high for an administrative database, it is possible at least some portion of our cohort may be incorrectly coded. Further, the NSQIP complications we identified may represent associated comorbidities and not true postoperative complications, as NIS does not provide temporal relationships between different diagnosis codes. Despite these limitations, we note that the NIS database is rigorously monitored and audited for coding accuracy and, therefore, represents a reasonably reliable panorama of the characteristics of an inpatient surgical cohort. However, it is important to note that the choice of operative modality is, undoubtedly, multifactorial and patient/setting-specific.ConclusionsThere is increasing use of MIS for pediatric urology procedures, although utilization rates vary among procedures. MIS was associated with a lower postoperative complication rate than for open procedures. Higher-volume MIS centers have a lower complication rate than lower-volume centers.

Project description:BackgroundThoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems.Methods/designsThis study is designed as a multi-center, randomized controlled trial of patients aged 18-65 years who are scheduled to undergo surgical posterior fixation. Treatment by the conventional open approach or percutaneous minimally invasive approach will be randomly assigned. The primary outcome measure is postoperative pain, which will be measured using the visual analogue scale (VAS). The secondary outcome parameters are intraoperative bleeding, postoperative drainage, surgery time, length of hospital stay, SF-36, EQ-5D-5 l, HADS, pain medication, deambulation after surgery, intraoperative fluoroscopy time, vertebral segment kyphosis, fracture vertebral body height, compression of the vertebral canal, accuracy of the pedicle screws, and breakage or release of the implants. Patient will be followed up for 1, 2, 3, 6, 12 and 24 months postoperatively and evaluated according to the outcomes using clinical and radiological examinations, plain radiographs and computed tomografy (CT).DiscussionSurgical treatment of thoracolumbar fractures by the open or percutaneous minimally invasive approach will be compared in a multicenter randomized study using similar types of fixation systems, and the results will be evaluated according to clinical and radiological parameters at 1, 2, 3, 6, 12 and 24 months of follow-up.Trial registrationClinicalTrial.gov approval number: 1.933.631, code: NCT03316703 in may 2017.

Project description:ImportanceGlaucoma affects more than 75 million people worldwide. Intraocular pressure (IOP)-lowering surgery is an important treatment for this disease. Interest in reducing surgical morbidity has led to the introduction of minimally invasive glaucoma surgeries (MIGS). Understanding the comparative effectiveness and safety of MIGS is necessary for clinicians and patients.ObjectiveTo summarize data from randomized clinical trials of MIGS for open-angle glaucoma, which were evaluated in a suite of Cochrane reviews.Data sourcesThe Cochrane Database of Systematic Reviews including studies published before June 1, 2021.Study selectionReviews of randomized clinical trials comparing MIGS with cataract extraction alone, other MIGS, traditional glaucoma surgery, laser trabeculoplasty, or medical therapy.Data extraction and synthesisData were extracted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines by one investigator and confirmed by a second. Methodologic rigor was assessed using the AMSTAR 2 appraisal tool and random-effects network meta-analyses were conducted.Main outcomes and measuresThe proportion of participants who did not need to use medication to reduce intraocular pressure (IOP) postsurgery (drop-free). Outcomes were analyzed at short-term (<6 months), medium-term (6-18 months), and long-term (>18 months) follow-up.ResultsSix eligible Cochrane reviews were identified discussing trabecular bypass with iStent or Hydrus microstents, ab interno trabeculotomy with Trabectome, subconjunctival and supraciliary drainage devices, and endoscopic cyclophotocoagulation. Moderate certainty evidence indicated that adding a Hydrus safely improved the likelihood of drop-free glaucoma control at medium-term (relative risk [RR], 1.6; 95% CI, 1.4 to 1.8) and long-term (RR, 1.6; 95% CI, 1.4 to 1.9) follow-up and conferred 2.0-mm Hg (95% CI, -2.7 to -1.3 mm Hg) greater IOP reduction at long-term follow-up, compared with cataract surgery alone. Adding an iStent also safely improved drop-free disease control compared with cataract surgery alone (RR, 1.4; 95% CI, 1.2 to 1.6), but the short-term IOP-lowering effect of the iStent was not sustained. Addition of a CyPass microstent improved drop-free glaucoma control compared with cataract surgery alone (RR, 1.3; 95% CI, 1.1 to 1.5) but was associated with an increased risk of vraision loss. Network meta-analyses supported the direction and magnitude of these results.Conclusions and relevanceBased on data synthesized in Cochrane reviews, some MIGS may afford patients with glaucoma greater drop-free disease control than cataract surgery alone. Among the products currently available, randomized clinical trial data associate the Hydrus with greater drop-free glaucoma control and IOP lowering than the iStent; however, these effect sizes were small.

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Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

Publications

Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

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