ROMIO feasibility: Randomised controlled trial of minimally invasive or open oesophagectomy
Ontology highlight
ABSTRACT:
DISEASE(S): Upper Gastro-intestinal Cancer/oesophageal Cancer
PROVIDER: 2420381 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:IntroductionSurgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.Methods and analysisWe will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.Ethics and disseminationThis study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.Trial registration numberISRCTN10386621.
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Project description:Posterior cervical laminoforaminotomy is an effective treatment for cervical radiculopathy due to disc herniations or spondylosis. Over the last decade, minimally invasive (i.e., percutaneous) procedures have become increasingly popular due to a smaller incision size and presumed benefits in postoperative outcomes. We performed a systematic review of the literature and identified studies of open or percutaneous laminoforaminotomy that reported one or more perioperative outcomes. Of 162 publications found by our initial screening, 19 were included in the final analysis. Summative results indicate that patients undergoing percutaneous cervical laminoforaminotomy have lower blood loss by 120.7 mL (open: 173.5 mL, percutaneous: 52.8 mL, n = 670), a shorter surgical time by 50.0 minutes (open: 108.3 minutes, percutaneous: 58.3 minutes, n = 882), less inpatient analgesic use by 25.1 Eq (open: 27.6 Eq, percutaneous: 2.5 Eq, n = 356), and a shorter hospital stay by 2.2 days (open: 3.2 days, percutaneous: 1.0 days, n = 1472), compared with patients undergoing open procedures. However, the heterogeneous nature of published data calls into question the reliability of these summative results. Further structured trials should be conducted to better characterize the risks and benefits of percutaneous laminoforaminotomy.
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Project description:Background Oesophageal cancer is the eighth most common cause of cancer worldwide. In recent years, the frequency to use minimally invasive surgical methods for esophagectomy has been increased, but its real advantages over conventional surgery is still remains. The aim of this study is to compare patients who underwent open three-stage transthoracic oesophagectomy with those who underwent minimally invasive thoraco-laparoscopic oesophagectomy (MIO) to ascertain the feasibility, safety, and clinical advantages of the MIO. Methods We did a multicentre prospective, open and parallel, randomised controlled trial in six study centres between April 1st, 2014, and April 30th, 2018. Patients aged 18–75 years with resectable middle and upper esophageal cancer were randomly assigned via a computer-generated randomisation sequence to receive either open three-stage transthoracic oesophagectomy (Group A) or MIO (Group B). The perioperative outcomes were to compare operative time, intraoperative blood loss, total expenses in hospital, hospital stay, the number and location of lymph nodes harvested and respiratory complications within 30 days. This trial is registered with ClinicalTrials.gov Identifier: NCT02355249. Results We randomly assigned 339 patients to the Group A and 156 to the Group B. No differences emerged in terms of age (year) [(61.52±8.52) vs. (60.25±6.28), P=0.67], the median lengths of hospital stay (day) [(16.28±8.02) vs. (17.15±11.74), P=0.08]. Group A has less intraoperative blood loss (mL) [(241.1±165.8) vs. (274.0±169.8), P<0.05] and total expenses in hospital (?) [(92,076±27,889) vs. (107,669±32,655), P<0.05], shorter operative time (min) [(267±92.2) vs. (364.3±99.43), P<0.05]. While Group B has palpable advantage in the number [(18.30±11.44) vs. (23.08±12.45), P<0.05] and location [(4.30±2.16) vs. (5.44±2.37), P<0.05] of lymph nodes harvested. The proportion of respiratory complications within 30 days was no statistical difference in the Group B [21/156 (13.5%)] compared to the Group A [45/339 (13.3%)] (Chi-square sig =0.934, P>0.05). Meanwhile, the study makes clear that tumour size has no correlation to operative time (Spearman r =?0.014, P>0.05) and intraoperative blood loss (Spearman r =0.078, P>0.05). Conclusions Compared to open three-stage transthoracic oesophagectomy, MIO has prominent representation in lymph nodes harvested which is fatal to estimate prognosis and plan sequential treatment plan, although, MIO has some disadvantage such as longer operative time, more intraoperative blood loss and total expenses in hospital which is conflicting to previous observational studies conclusion. There is no statistical difference in respiratory complications within 30 days between the two surgical approaches. Next step, survival rate after 2 years will be analyzed and published after the follow-up work is finished.
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Project description:Adrenocortical carcinoma (ACC) is a rare malignancy with a poor prognosis. Although laparoscopy has been widely adopted for management of benign adrenal tumors, minimally invasive surgery for ACC remains controversial. Retrospective analyses, frequently with fewer than one hundred participants, comprise the majority of the literature. High-quality data regarding the optimal surgical approach for ACC are lacking due to the rarity of the disease and the fact that determination of tumor type (e.g., adenoma or carcinoma) is determined after adrenalectomy, since adrenal tumors are generally not biopsied. While the benefits of minimally invasive surgery including lower intra-operative blood loss and decreased hospital length-of-stay have been consistently demonstrated, clinical equipoise for long-term survival and recurrence outcomes between open and minimally invasive adrenalectomy (MIA) remains. This review examines retrospective studies that directly compare patients with ACC who underwent either open or laparoscopic adrenalectomy, and considers these findings in the context of current guideline recommendations for surgical management of ACC.
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Project description:Background:The development of minimally invasive surgery has initiated many changes in the surgical treatment of esophageal cancer (EC) patients. The aim of this study was to compare the short-term outcomes of robotic-assisted minimally invasive esophagectomy (RAMIE), video-assisted minimally invasive esophagectomy (VAMIE), and open esophagectomy (OE). Methods:Our study included patients who had undergone McKeown esophagectomy at Tianjin Medical University Cancer Institute and Hospital between January 2016 and December 2018. We analyzed clinical baseline data, as well as perioperative and pathological outcomes. Results:A total of 312 cases met the inclusion criteria (OE: 77, VAMIE: 144, RAMIE: 91). The OE group had a greater number of late-stage patients as well as those who received the neo-adjuvant therapy, compared with the other two groups (P=0.001). The procedure time in the OE group was also shorter by approximately 20 minutes (P=0.021). Total blood loss was significantly lower in the two MIE groups (P=0.004) than in the OE group. There were no differences in the total number of dissected lymph nodes between the three groups (OE: 24.09±10.77, VAMIE: 23.07±10.18, RAMIE: 22.84±8.37, P=0.680). Both the lymph node number (P=0.155) and achievement rate (P=0.190) in the right recurrent laryngeal nerve (RLN) area were comparable between the three groups. However, in the left RLN area, minimally invasive approaches resulted in a higher number of harvested lymph nodes (P=0.032) and greater achievement rate (P=0.018). Neither MIE procedure increased the incidence of postoperative complications. Conclusions:Minimally invasive surgery could guarantee the quality of bilateral RLN lymphadenectomy without increasing postoperative complications, especially in RAMIE patients. The rational choice of different surgical approaches would improve both safety and oncological outcomes for patients.
| S-EPMC7139097 | biostudies-literature
Project description:Esophagectomy for esophageal malignancies remains an operation with significant potential morbidity and mortality. However, surgical outcomes continue to improve over time and focus has shifted toward not just good outcomes, but quality of life post operatively. Patient reported outcomes (PROs) focus of quality of life measures via validated patient surveys has increasingly become a significant focus. While PROs do have their limitations, they represent a glimpse into the symptomatology, quality of life, and well-being of a patient undergoing a procedure with inherent morbidity. Working to improve outcomes from the perspective of the patient is not a new concept, but has becoming increasingly relevant as surgical quality for all procedures improves. The optimal approach to esophagectomy is controversial. Minimally invasive approaches attempt to avoid laparotomy and thoracotomy with the thought of improving post-operative quality of life by mitigating complications related to those open surgical approaches. The data in favor of laparoscopy and thoracoscopy is quite strong and multiple randomized controlled trials exist in this realm supporting minimally invasive approaches with regards to quality of life outcomes and more rapid return to patient's preoperative baseline. The data in favor of a robotic approach for esophagectomy is not quite as robust, but more studies show that these approaches mirror the benefits of the laparoscopic and thoracoscopic approaches without robotic assistance.
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