Background: Neoadjuvant chemoradiotherapy followed by radical surgery is the common treatment for patients with locally advanced rectal cancer. Presently, for patients with complete clinical response after neoadjuvant chemoradiotherapy, organ preservation ("watch-and-wait" and local excision strategies) has been increasingly favored. However, the optimal treatment for patients with complete clinical response remains unclear.
Objective: This study aimed to use Bayesian meta-analysis to determine the best treatment for patients with locally advanced rectal cancer with complete clinical response among radical surgery, local excision, and watch-and-wait strategies.
Data sources: PubMed, Web of Science, Cochrane Library, and Embase (Ovid) databases were searched for literature published through December 31, 2023.
Study selection: Studies that compared 2 or more treatments for patients with complete clinical response were included.
Intervention: The analysis was completed via Bayesian meta-analysis using a random-effects model.
Main outcome measures: Surgery-related complications, local recurrence, distant metastasis, and 5-year overall and disease-free survival rates.
Results: Eleven articles met the inclusion criteria. The watch-and-wait group and local excision group exhibited a higher rate of tumor recurrence compared to the radical surgery group (watch-and-wait vs radical surgery: OR, 9.10 [95% CI, 3.30-32.3]; local excision vs radical surgery: OR, 2.93 [95% CI, 1.05-9.95]). The distant metastasis, overall survival, and disease-free survival rates of the 3 treatments were not statistically different. The radical surgery group had the most number of stomas and had the greatest risk of morbidity than the watch-and-wait group (watch-and-wait vs radical surgery: OR, 0.00 [95% CI, 0.00-0.12]).
Limitations: The study included only 1 randomized controlled trial compared to 10 observational studies, which could affect overall quality. Funnel plots of disease-free survival rates and stoma suggest significant publication bias among studies that compared radical surgery with the watch-and-wait strategy.
Conclusions: The watch-and-wait strategy could be optimal for patients with locally advanced rectal cancer with complete clinical response after neoadjuvant chemoradiotherapy.
Background: The total mesorectal excision technique is associated with improved outcomes for rectal cancer, and grading the total mesorectal excision specimen is recommended. We implemented a multimodal intervention in Michigan Surgical Quality Collaborative hospitals to increase total mesorectal excision grading.
Objective: To compare total mesorectal excision grading rates over time between hospitals that received the intervention early and late in the study.
Design: Stepped wedge randomized controlled trial with hospitals randomized to receive the education intervention early in the trial or one year later. We used a generalized linear mixed model to compare rates of total mesorectal excision grading over time between groups, adjusting for hospital characteristics.
Setting: Twelve hospitals within the Michigan Surgical Quality Collaborative.
Patients: Adult patients undergoing total mesorectal excision for rectal cancer from 2014 to 2021.
Intervention: A multimodal educational intervention consisting of a webinar about total mesorectal excision grading, a pre- and post-webinar quiz, and site visits.
Main outcome measures: Total mesorectal excision grading rate for each hospital over time.
Results: From 2014 to 2021, 560 patients underwent total mesorectal excision in participating hospitals, 350 at early intervention hospitals and 210 in late intervention hospitals. The early intervention began August 2018, and the late intervention began June 2019. Based on the mixed model, grading in early hospitals increased from 8.1% to 99.7% at the end of the study (p < 0.001). In the late group, grading increased from 47.8% to 94.0% (p < 0.001). The intervention was not associated with a change in total mesorectal excision grading in either group; rather, the increase in grading corresponded with a statewide collaborative presentation on this topic in December 2016.
Limitations: Selection bias, as hospitals recruited to participate were already participating in colorectal cancer quality improvement and may reflect greater commitment to high-quality rectal cancer care.
Conclusions: Our findings show an increase in total mesorectal excision grading in Michigan from 2014-2021 that preceded the dates of our intervention. These results highlight the importance of accounting for secular trends in measuring healthcare quality improvement interventions. See Video Abstract.
Background: The choice of operation for chronic pilonidal sinus disease remains controversial.
Objective: To compare the outcomes of common operations for chronic pilonidal disease.
Data sources: We searched PubMed, Embase, and Cochrane Library.
Study selection: We included randomized trials in English or Danish language, published 2002-2024 comparing operations treating chronic pilonidal disease in adults and teenagers.
Interventions: We compared the outcomes of secondary healing, primary midline closure, Bascom's-, Limberg's- and Karydakis' flap operations.
Main outcome measures: The primary outcome was recurrence; secondary outcomes were infection, healing time, and length-of-stay. We compared recurrence and infection rates in meta-analyses for all techniques. We assessed the risk-of-bias and the quality of all trials.
Results: Fifty trials included a total of 5762 participants. In a meta-analysis, the flap-operations had fewer recurrences than primary midline closure (OR 0.31 (95% CI, 0.19 to 0.51, p < 0.01). The trials comparing Flap-operations with secondary healing were heterogeneous and did not reach significance (OR 0.38 (95% CI, 0.13 to 1.13, p = 0.08). Recurrence was similar between Limberg's- and Karydakis' operations. Infection rates were lower for the flap-operations compared with primary closure (OR 0.33 (95% CI, 0.23 to 0.48, p < 0.01) and with secondary healing (OR 0.48 (95% CI, 0.30 to 0.77, p < 0.01). Two trials tested Bascom's procedure against Limberg's operation without significant differences. All trials found secondary healing to have significantly longer healing times than any other operation.
Limitations: Most studies had a high or medium risk-of-bias, resulting in very-low to low certainty of evidence. The trials generally had small numbers, short follow-ups, and no reported primary outcomes or power calculations.
Conclusions: Primary closure and secondary healing performed poorly compared with the flap techniques. Most trials tested Limberg's operation; only 2 tested Bascom's operation. The literature suggests the surgeon's expertise determines the choice of flap technique.
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