Dataset Information

Robotic beyond total mesorectal excision (TME) for locally advanced or recurrent rectal cancer: a systematic review protocol.

ABSTRACT:

Introduction

The surgical treatment for locally advanced or recurrent rectal cancer requires oncological clearance with a pelvic exenteration or a beyond total mesorectal excision (TME). The aim of this systematic review is to explore the safety and feasibility of robotic surgery in locally advanced and recurrent rectal cancer by evaluating perioperative outcomes, oncological clearance rates, and survival and recurrence rates postrobotic beyond TME surgery.

Methods

The systematic review will include studies published until the end of December 2023. The MEDLINE, EMBASE and Scopus databases will be searched. The screening process, study selection, data extraction, quality assessment and analysis will be performed by two independent reviewers. Discrepancies will be resolved by consensus with a third independent reviewer. The risk of bias will be assessed with validated scores. The primary outcomes will be oncological clearance, overall and disease-free survival, and local and systemic recurrence rates post robotic or robot-assisted beyond TME surgery for locally advanced or recurrent rectal cancer. Secondary outcomes will include perioperative outcomes.

Ethics and dissemination

No ethical approval is required for this systematic review as no individual patient cases are studied requiring access to individual medical records. The results of the systematic review will be disseminated with conference presentations and peer-reviewed paper publications.

Prospero registration of the study

CRD42023408098.

SUBMITTER: Panagiotopoulou IG

PROVIDER: S-EPMC10824024 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

Robotic beyond total mesorectal excision (TME) for locally advanced or recurrent rectal cancer: a systematic review protocol.

Panagiotopoulou Ioanna Georgiou IG Przedlacka Anna A Piozzi Guglielmo Niccolò GN Mills Graham A GA Harper Mick M Khan Jim S JS

BMJ open 20240125 1

<h4>Introduction</h4>The surgical treatment for locally advanced or recurrent rectal cancer requires oncological clearance with a pelvic exenteration or a beyond total mesorectal excision (TME). The aim of this systematic review is to explore the safety and feasibility of robotic surgery in locally advanced and recurrent rectal cancer by evaluating perioperative outcomes, oncological clearance rates, and survival and recurrence rates postrobotic beyond TME surgery.<h4>Methods</h4>The systematic ...[more]

PMID: 38272558

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Project description:BackgroundPreoperative chemoradiotherapy (PCRT) followed by surgery and adjuvant chemotherapy is the current standard treatment for stage II/III rectal cancer. However, radiotherapy in the pelvic area is commonly associated with complications such as anastomotic leakage, sexual dysfunction, and fecal incontinence. Recently, the MERCURY study showed that preoperative high-resolution magnetic resonance imaging (MRI) helped to selectively avoid PCRT. It remains unclear whether PCRT is necessary in patients who can achieve a negative circumferential resection margin (CRM) with surgery alone and in patients with cT1-2N1 or cT3N0 without CRM involvement and lateral lymph node metastasis. This study aims to evaluate the efficacy of upfront radical surgery with total mesorectal excision (TME) followed by adjuvant chemotherapy with folinic acid (or leucovorin), fluorouracil, and oxaliplatin (FOLFOX) versus the current standard treatment in patients with surgically resectable, locally advanced rectal cancer.MethodsThis study, named TME-FOLFOX, is a prospective, open-label, multicenter, phase II randomized trial. Patients with locally advanced rectal cancer will be randomized to receive PCRT followed by TME and adjuvant chemotherapy (arm A) or upfront radical surgery with TME followed by adjuvant FOLFOX chemotherapy (arm B). Clinical stage II/III rectal cancer without CRM involvement and lateral lymph node metastasis will be defined using preoperative MRI. The primary endpoint is 3-year disease-free survival (DFS). Secondary endpoints include 5-year DFS, local recurrence rate, systemic recurrence rate, cost-effectiveness, and overall survival. We hypothesized that our experimental group (arm B) will have a 3-year DFS of 75% and a non-inferiority margin of 15%.DiscussionIdentifying whether patients require PCRT is one of the critical issues in locally advanced rectal cancer. This study aims to elucidate whether PCRT may not be required for all patients with stage II/III rectal cancer, especially for the MRI-based intermediate-risk group (with cT1-2N1 or cT3N0) without CRM involvement and lateral lymph node metastasis. If the findings indicate that our proposed treatment, which omits PCRT, is non-inferior to the standard treatment, then patients may avoid unnecessary radiation-related toxicity, have a shorter treatment duration, and save on medical costs.Trial registrationClinicalTrials.gov, NCT02167321. Registered on 19 June 2014.

Project description:BackgroundColorectal cancer screening programmes have led to a shift towards early-stage colorectal cancer, which, in selected cases, can be treated using local excision. However, local excision followed by completion total mesorectal excision (two-stage approach) may be associated with less favourable outcomes than primary total mesorectal excision (one-stage approach). The aim of this population study was to determine the distribution of treatment strategies for early rectal cancer in the Netherlands and to compare the short-term outcomes of primary total mesorectal excision with those of local excision followed by completion total mesorectal excision.MethodsShort-term data for patients with cT1-2 N0xM0 rectal cancer who underwent local excision only, primary total mesorectal excision, or local excision followed by completion total mesorectal excision between 2012 and 2020 in the Netherlands were collected from the Dutch Colorectal Audit. Patients were categorized according to treatment groups and logistic regressions were performed after multiple imputation and propensity score matching. The primary outcome was the end-ostomy rate.ResultsFrom 2015 to 2020, the proportion for the two-stage approach increased from 22.3% to 43.9%. After matching, 1062 patients were included. The end-ostomy rate was 16.8% for the primary total mesorectal excision group versus 29.6% for the local excision followed by completion total mesorectal excision group (P < 0.001). The primary total mesorectal excision group had a higher re-intervention rate than the local excision followed by completion total mesorectal excision group (16.7% versus 11.8%; P = 0.048). No differences were observed with regard to complications, conversion, diverting ostomies, radical resections, readmissions, and death.ConclusionThis study shows that, over time, cT1-2 rectal cancer has increasingly been treated using the two-stage approach. However, local excision followed by completion total mesorectal excision seems to be associated with an elevated end-ostomy rate. It is important that clinicians and patients are aware of this risk during shared decision-making.

Project description:IntroductionThe implementation of an Enhanced Recovery After Surgery (ERAS) protocol in patients with locally advanced rectal cancer (LARC) and locally recurrent rectal cancer (LRRC) has been deemed unfeasible until now because of the heterogeneity of this disease and low caseloads. Since evidence and experience with ERAS principles in colorectal cancer care are increasing, a modified ERAS protocol for this specific group has been developed. The aim of this study is to evaluate the implementation of a tailored ERAS protocol for patients with LARC or LRRC, requiring beyond total mesorectal excision (bTME) surgery.MethodsPatients who underwent a bTME for LARC or LRRC between October 2021 and December 2022 were prospectively studied. All patients were treated in accordance with the ERAS LARRC protocol, which consisted of 39 ERAS care elements specifically developed for patients with LARC and LRRC. One of the most important adaptations of this protocol was the anaesthesia procedure, which involved the use of total intravenous anaesthesia with intravenous (iv) lidocaine, iv methadone, and iv ketamine instead of epidural anaesthesia. The outcomes showed compliance with ERAS care elements, complications, length of stay, and functional recovery. A follow-up was performed at 30 and 90 days post-surgery.ResultsSeventy-two patients were selected, all of whom underwent bTME for either LARC (54.2%) or LRRC (45.8%). Total compliance with the adjusted ERAS protocol was 73.6%. Major complications were present in 12 patients (16.7%), and the median length of hospital stay was 9 days (IQR 6.0-14.0). Patients who received multimodal anaesthesia (75.0%) stayed in the hospital for a median of 7.0 days (IQR 6.8-15.5). These patients received fewer opioids on the first three postoperative days than patients who received epidural analgesia (p < 0.001).ConclusionsThe implementation of the ERAS LARRC protocol seemed successful according to its compliance rate of >70%. Its complication rate was substantially reduced in comparison with the literature. Multimodal anaesthesia is feasible in beyond TME surgery with promising effects on recovery after surgery.

Dataset Information

Robotic beyond total mesorectal excision (TME) for locally advanced or recurrent rectal cancer: a systematic review protocol.

Introduction

Methods

Ethics and dissemination

Prospero registration of the study

Publications

Robotic beyond total mesorectal excision (TME) for locally advanced or recurrent rectal cancer: a systematic review protocol.

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