Dataset Information

Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial).

ABSTRACT:

Background

Minimally invasive surgery (MIS) and enhanced recovery protocols (ERPs) have improved postoperative recovery and shortened length of hospital stay (LOS). Telemedicine technology has potential to improve outcomes and patient experience further. This study was designed to determine whether the combination of MIS, ERP and a structured telemedicine programme (TeleRecovery) could shorten total 30-day LOS by 50 per cent.

Methods

This was a phase II prospective RCT at a large academic medical centre. Eligible patients aged 18-80?years undergoing minimally invasive colorectal resection using an ERP were randomized after surgery. The experimental arm (RecoverMI) included accelerated discharge on postoperative day (POD) 1 with or without evidence of bowel function and a televideoconference on POD 2. The control arm was standard postoperative care. The primary endpoint was total 30-day LOS (postoperative stay plus readmission/emergency department/observation days). Secondary endpoints included patient-reported outcomes measured by EQ-5D-5L™, Brief Pain Inventory (BPI) and a satisfaction questionnaire.

Results

Thirty patients were randomized after robotic (21 patients) or laparoscopic (9) colectomy, including 14 patients in the RecoverMI arm. Median 30-day total LOS was 28·3 (i.q.r. 23·7-43·6) h in the RecoverMI arm and 51·5 (43·8-67·0)?h in the control arm (P?=?0·041). There were no differences in severe adverse events or EQ-5D-5L™ score between the study arms. The BPI revealed low pain scores regardless of treatment arm. Satisfaction was high in both arms.

Conclusion

In patients having surgery for colorectal neoplasms, the trimodal combination of MIS, ERP and TeleRecovery can reduce 30-day LOS while preserving patients' quality of life and satisfaction. Registration number: NCT02613728 ( https://clinicaltrials.gov).

SUBMITTER: Bednarski BK

PROVIDER: S-EPMC7938853 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial).

Bednarski B K BK Nickerson T P TP You Y N YN Messick C A CA Speer B B Gottumukkala V V Manandhar M M Weldon M M Dean E M EM Qiao W W Wang X X Chang G J GJ

The British journal of surgery 20190619 10

<h4>Background</h4>Minimally invasive surgery (MIS) and enhanced recovery protocols (ERPs) have improved postoperative recovery and shortened length of hospital stay (LOS). Telemedicine technology has potential to improve outcomes and patient experience further. This study was designed to determine whether the combination of MIS, ERP and a structured telemedicine programme (TeleRecovery) could shorten total 30-day LOS by 50 per cent.<h4>Methods</h4>This was a phase II prospective RCT at a large ...[more]

PMID: 31216065

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Project description:Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation.In order to address this gap, we propose a prospective randomised trial of accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI) that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology (TeleRecovery) to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. ETHICS AND DISSEMINATION: RecoverMI has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial.NCT02613728; Pre-results.

Project description:Objectives: Although previous studies have shown the feasibility of non-intubated techniques, it is unknown whether avoiding urinary catheters can enhance recovery. This study aimed to determine whether the tubeless urinary catheter protocol is feasible and beneficial for minimally invasive lung surgery. Methods: Patients were randomized to the control group, completely tubeless group, and partially tubeless group. A propensity score-matched (PSM) analysis was performed to balance the non-random baseline characteristics. Complications and postoperative recovery were compared. Regression analysis was performed to identify the independent predictors of complications. A nomogram for predicting the risk of non-automatic micturition was constructed and internally validated. Results: One hundred fifty-nine patients were enrolled. The incidence rates of urinary irritation and urinary tract infection (UTI) were significantly lower in the tubeless groups (74.4 vs. 39.5%, p < 0.001; 28.2 vs. 8.6%, p = 0.001, respectively). The tubeless group had a higher proportion of 0-degree discomfort (81.5 vs. 30.8%, p = 0.001) and shorter duration of postoperative hospital stay than the control group (4.59 vs. 5.53 days, p < 0.001). No difference was observed in terms of urination retention and urinary incontinence between the tubeless group and the control group. After PSM, the advantages of the tubeless group still existed, and comparing to the partially tubeless group, the completely tubeless group was of even less UTI and more 0-degree discomfort (18.5 vs. 0.0%, p = 0.019; 96.3 vs. 59.3%, p = 0.002). The tubeless protocol was the only independent protective factor of urinary complications. A nomogram was constructed and showed good predictive ability. Conclusions: The tubeless catheterization protocol led to fewer complications, better compliance, and shorter hospital length of stay. The advantages were more significant with the completely tubeless protocol. The utility of our nomogram can assist clinicians in avoiding risks in performing the tubeless protocol.

Project description:BackgroundEnhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).MethodsThis observational study evaluated the implementation of ERP in gynaecologic oncological surgery in a minimally invasive techniques (MIT) expert center with more than 85% of procedures done with MIT. We compared a prospective cohort of 100 patients involved in ERP between December 2015 and June 2016 to a 100 patients control group, without ERP, previously managed in the same center between April 2015 and November 2015. All the included patients were referred for hysterectomy and/or pelvic or para-aortic lymphadenectomy for gynaecological cancer. The primary objective was to achieve a significant decrease of median LOS in the ERP group. Secondary objectives were decreases in proportion of patients achieving target LOS (2 days), morbidity and readmissions.ResultsExcept a disparity in oncological indications with a higher proportion of endometrial cancer in the group with ERP vs. the group without ERP (42% vs. 22%; p = 0.003), there were no differences in patient's characteristics and surgical procedures. ERP were associated with decreases of median LOS (2.5 [0 to 11] days vs. 3 [1 to 14] days; p = 0.002) and proportion of discharged patient at target LOS (45% vs. 24%; p = 0.002). Morbidities occurred in 25% and 26% in the groups with and without ERP and readmission rates were respectively of 6% and 8%, without any significant difference.ConclusionERP in gynaecologic oncological surgery is associated with a decrease of LOS without increases of morbidity or readmission rates, even in a center with a high proportion of MIT. Although it is already widely accepted that MIT improves early recovery, our study shows that the addition of ERP's clinical pathways improve surgical outcomes and patient care management.

Dataset Information

Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial).

Background

Methods

Results

Conclusion

Publications

Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial).

Similar Datasets

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