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Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.

ABSTRACT: BACKGROUND:Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques. METHODS/DESIGN:MIRCAST is the Minimally-Invasive Right Colectomy Anastomosis Study that will compare laparoscopy with robot-assisted surgery, using either intracorporeal or extracorporeal anastomosis, in a large prospective, observational, multicenter, parallel, four-cohort study in patients with a benign or malignant, non-metastatic tumor of the right colon. Over 2?years of follow-up, the study will prospectively evaluate peri- and postoperative complications, postoperative recovery, hospital stay, and mid-term results including survival, local recurrence, metastases rate, and conversion rate. The primary composite endpoint will be the efficacy of the surgical method regarding surgical wound infections and postoperative complications (Clavien-Dindo grade III-IV complications at 30?days post-surgery). Secondary endpoints include long-term oncologic results, conversion rate, operative time, length of stay, and quality of life. DISCUSSION:This will be the first large, international study to prospectively evaluate the use of minimally-invasive laparoscopy or robot-assisted surgery during right hemicolectomy and to control for the impact of the anastomotic technique. The research will contribute to current knowledge regarding the medical care of patients with malignant or benign tumors of the right colon, and enable physicians to determine which technique may be the most appropriate for their patients. TRIAL REGISTRATION:This study was registered on Clinicaltrials.gov (clinicaltrials.gov identifier: NCT03650517 ) on August 28th 2018 (study protocol version CI18/02 revision A, 21 February 2018).

SUBMITTER: Gomez Ruiz M

PROVIDER: S-EPMC7359244 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.

Gomez Ruiz Marcos M Bianchi Paolo Pietro PP Chaudhri Sanjay S Gerjy Roger R Gögenur Ismail I Jayne David D Khan Jim S JS Rautio Tero T Sánchez-Guillén Luis L Spinoglio Giuseppe G Ulrich Alexis A Rouanet Philippe P

BMC surgery 20200713 1

<h4>Background</h4>Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques.<h4>Methods/design</h4>MIRCAST is the Minimally-Invasive Right Colectomy ...[more]

PMID: 32660467

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Project description:ImportanceMinimally invasive colectomy (MIC) is an increasingly common surgical procedure. Although case series and controlled prospective trials have found the procedure to be safe, it is unclear whether safe adaptation of this approach from open colectomy (OC) is occurring among surgeons.ObjectiveTo assess rates of complications for MIC compared with OC among surgeons.Design, setting, and participantsWe analyzed 5196 patients who underwent MIC or OC from January 1, 2012, through December 31, 2015, by 97 surgeons in the Michigan Surgical Quality Collaborative, with each surgeon performing at least 10 OCs and 10 MICs. Hierarchical regression was used to assess surgeon variation in adjusted rates of complications and the association of these outcomes across approaches.Main outcomes and measuresPrimary study outcome measurements included overall 30-day complication rates, variation in complication rates among surgeons, and surgeon rank by complication rate for MIC vs OC.ResultsOf the 5196 patients (mean [SD] age, 62.9 [14.4] years; 2842 [54.7%] female; 4429 [85.2%] white), 3118 (60.0%) underwent MIC and 2078 (40.0%) underwent OC. Overall, 1149 patients (22.1%) experienced complications (702 [33.8%] in the OC group vs 447 [14.3%] in the MIC group; P < .001). For MIC, the rates of complications varied from 8.8% to 25.9% among surgeons. For OC, rates of complications were higher but varied less (1.7-fold) among surgeons, ranging from 25.9% to 43.8%. Among the 97 surgeons ranked, the mean change in ranking between OC and MIC was 25 positions. The top 10 surgeons ranged in rank from 6 of 97 for OC to 89 of 97 for MIC.Conclusions and relevanceSurgeon-level variation in complications was nearly twice as great for MIC than for OC among surgeons enrolled in a statewide quality collaborative. Moreover, surgeon rankings for OC outcomes differed substantially from outcomes for those same surgeons performing MIC. This finding implies a need for improved training in adoption of MIC techniques among some surgeons.

Project description:BackgroundA central lymphadenectomy in right-sided colon cancer involves dissection along the superior mesenteric axis, but the extent is debated due to a lack of consensus and the fear of major complications. This randomized controlled trial compared the rate of postoperative morbidity in patients undergoing laparoscopic versus open right-sided colectomy with central lymphadenectomy.MethodsThis open, prospective, randomized controlled trial compared patients operated on with open and laparoscopic right-sided colectomy (cStages I-III) with a central lymphadenectomy at two Norwegian institutions between October 2016 and December 2021. Dissections were conducted along the superior mesenteric vein in the laparoscopic group, and along the left anterior border of the superior mesenteric artery in the open group, both according to complete mesocolic excision principles. Surgery was standardized and performed by three experienced surgeons for each study group. The primary outcome of interest was to measure postoperative 30-day complications (Clavien-Dindo ≥ grade II).ResultsOf 273 eligible patients, 135 were randomized and 128 analysed (63 operated on with open and 65 using laparoscopic procedures). Postoperative complications occurred in 42.8 per cent of the patients treated with open and 38.4 per cent of the patients treated using laparoscopic surgery, P = 0.372. The incidence of Clavien-Dindo grade IIIb complications was 7.9 per cent in the open versus 4.6 per cent in the laparoscopic group, P = 0.341. There were no grade IV or V complications, and no re-operations due to anastomotic leakages. There was no significant difference in the mean(s.e.m.) number of removed lymph nodes (open versus laparoscopic respectively: 31.9(1.8) versus 29.3(1.3); P = 0.235).ConclusionThere was no significant difference in complications between the two groups. Standardized oncologic right-sided colectomy with central lymphadenectomy along the mesenterial root was performed safely, both open and laparoscopic, with incidence of major complications ranging between 4.6 and 7.9 per cent and no re-operations for anastomotic leakage. Radicality in terms of lymphadenectomy was comparable between the two groups.Registration number: NCT03776591 (http://www.clinicaltrials.gov).

Project description:BackgroundSelection of intracorporeal anastomosis (IA) or extracorporeal anastomosis (EA) in laparoscopic right colectomy (LRC) remains controversial. This meta-analysis aimed to evaluate the effectiveness and safety of IA compared with EA in LRC patients.MethodsLiterature was searched systematically for randomized controlled trials (RCTs) that compared IA with EA in LRC patients until May 2021. The eligible studies for risk of bias were assessed using the Cochrane Risk of Bias Tool. Data were extracted and analysed for the following outcomes of interest: operative time, length of incision, nodal harvest, bowel function recovery, postoperative pain, postoperative complications (wound infection, anastomotic leak, ileus, obstruction, reoperation), death at 30 days, duration of hospital stay and 30-day readmission.ResultsFive RCTs, including a total of 559 patients, were eligible for meta-analysis. All of the trials reported adequate random sequence generation and allocation concealment. There were significantly better outcomes in the IA group than in the EA group in time to first flatus (mean difference (MD) -0.71 (95 per cent c.i. -1.12 to -0.31), P = 0.0005), time to first passage of stool (MD -0.53 (95 per cent c.i. -0.69 to -0.37), P < 0.00001), visual analogue scale of pain on postoperative day (POD) 3 (MD -0.76 (95 per cent c.i. -1.23 to -0.28), P = 0.002), POD 4 (MD -0.83 (95 per cent c.i. -1.46 to -0.20), P = 0.01), POD 5 (MD -0.60 (95 per cent c.i. -0.95 to -0.25), P = 0.0007), length of incision (MD -1.52 (95 per cent c.i. -2.30 to -0.74), P = 0.0001) and wound infection (relative risk 0.46 (95 per cent c.i. 0.23 to 0.91), P = 0.02). However, there were no statistically significant differences between the two groups in duration of hospital stay (P = 0.47), operative time (P = 0.07), number of lymph nodes harvested (P = 0.70), anastomotic leak (P = 0.88), postoperative ileus (P = 0.48), bleeding (P = 0.15), bowel obstruction (P = 0.24), reoperation (P = 0.34), readmission within 30 days (P = 0.26), and death (P = 0.70).ConclusionCompared with EA, IA shows a faster recovery of bowel function with fewer wound infections.

Dataset Information

Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.

Publications

Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.

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