Postoperative Surveillance in Patients With Colorectal Cancer Who Have Undergone Curative Resection: A Prospective, Multicenter, Randomized, Controlled Trial

2006 ◽  
Vol 24 (3) ◽  
pp. 386-393 ◽  
Author(s):  
Francisco Rodríguez-Moranta ◽  
Joan Saló ◽  
Àngels Arcusa ◽  
Jaume Boadas ◽  
Virgínia Piñol ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Tumor Recurrence ◽  
Controlled Trial ◽  
Stage Ii ◽  
Surveillance Strategy ◽  
Postoperative Surveillance ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Purpose Although systematic postoperative surveillance of patients with colorectal cancer has been demonstrated to improve survival, it remains unknown whether a more intensive strategy provides any significant advantage. This prospective, multicenter, randomized, controlled trial was aimed at comparing the efficacy of two different surveillance strategies in terms of both survival and recurrence resectability. Patients and Methods Patients with stage II or III colorectal cancer were allocated randomly to either a simple surveillance strategy including clinical evaluation and serum carcinoembryonic antigen monitoring, or an intensive strategy in which abdominal computed tomography or ultrasonography, chest radiograph, and colonoscopy were added. Results A total of 259 patients were included: 132 were observed according to the simple strategy and 127 were observed according to the intensive strategy. Both groups were similar with respect to baseline characteristics and rate and type of tumor recurrence. After a median follow-up of 48 months, there was no difference in the probability of overall survival in the whole series (hazard ratio [HR] = 0.87; 95% CI, 0.49 to 1.54; P = .62). However, the intensive strategy was associated with higher overall survival in patients with stage II tumors (HR = 0.34; 95% CI, 0.12 to 0.98; P = .045) and in those with rectal lesions (HR = 0.09; 95% CI, 0.01 to 0.81; P = .03), mainly due to higher rate of resectability for recurrent tumors. Colonoscopy was responsible for the detection of the highest proportion (44%) of resectable tumor recurrence in the intensive arm. Conclusion A more intensive surveillance strategy improves the prognosis of patients with stage II colorectal cancer or those with rectal tumors. Inclusion of regular performance of colonoscopy seems justified up to the fifth year of follow-up, at least.

Doxycycline Combined With Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis: A Multicenter Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Author(s):  
Kai-ni Shen ◽  
Wei-jun Fu ◽  
Yu Wu ◽  
Yu-jun Dong ◽  
Zhong-xia Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Light Chain ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Stage Ii ◽  
Control Group ◽  
Al Amyloidosis ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Background: Doxycycline was demonstrated in a retrospective study to be associated with greater survival in patients with light chain (AL) amyloidosis. Therefore, we prospectively compared the efficacy of bortezomib-cyclophosphamide-dexamethasone (CyBorD) and CyBorD combined with doxycycline for cardiac AL amyloidosis. Methods: This was a multicenter, open-label randomized controlled trial. Patients with Mayo 2004 stage II-III AL amyloidosis were included. Patients were randomized to doxycycline 100 mg twice daily along with 9 cycles of CyBorD (doxycycline group) or to 9 cycles of CyBorD alone (control group). The primary outcome was 2-year progression-free survival (PFS). PFS was defined as the time from randomization to death, hematologic progression or organ progression (heart, kidney or liver). Hematologic progression was defined based on substantial increase in free light chain. Increase in either N-terminal pro B-type natriuretic peptide or cardiac troponin was the main criterion for defining cardiac progression. Cardiac PFS, defined as the time from randomization to cardiac progression or death, was compared between groups in an exploratory analysis. The corresponding treatment hazard ratio was estimated using a Cox regression model. Results: 140 patients underwent randomization, with 70 in each group. The median age was 61 (range, 33-78) years with a male: female ratio of 1.75:1. Stage II disease was present in 34 (48.6%) and 33 (47.1%) patients in the doxycycline and control groups, respectively. After a median follow-up duration of 24.4 months, 32/70 (45.7%) of patients in the doxycycline group and 30/70 (42.9%) of patients in the control group experienced progression. PFS was not significantly different between groups (hazard ratio 0.97, 95% CI, 0.59-1.60, p =0.91). Cardiac progression occurred in 29/70 (41.4%) of patients in the doxycycline group and 26/70 (37.1%) of patients in the control group. The death rates for both groups by the end of follow-up was the same, 25/70 (35.7%). There were no significant differences observed for either cardiac PFS (hazard ratio 0.91, 95% CI, 0.54-1.55, p =0.74) or overall survival (hazard ratio 1.04, 95% CI, 0.60-1.81, p =0.89). Conclusions: Our trial demonstrated that doxycycline combined with CyBorD failed to prolong PFS or cardiac PFS compared with CyBorD alone in cardiac AL amyloidosis. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03401372.

scholarly journals OT-Equator® Attachments Comparison for Retaining an Early Loaded Implant Overdenture on Two or Three Implants: 1 Year RCT Preliminary Data

2021 ◽  
Vol 11 (18) ◽  
pp. 8601
Author(s):  
Marco Tallarico ◽  
Gabriele Cervino ◽  
Marco Montanari ◽  
Roberto Scrascia ◽  
Emiliano Ferrari ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Survival Rates ◽  
Marginal Bone Loss ◽  
Patient Centered ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Long Term Follow Up ◽  
Implant Overdenture

The purpose of this multicenter randomized controlled trial was to compare the clinical, radiographic, and patient-centered outcomes of early loaded mandibular overdentures deliberately placed on two or three implants. The outcomes were: implant and prosthesis success and survival rates; biological and technical complications; marginal bone loss; patient satisfaction; and periodontal parameters. The results showed no differences between the groups in any of the outcomes analyzed. With the limitations of the present study, and looking at long-term follow-up, the gold standard of prosthetic rehabilitations with attachments, in agreement with the scientific community, should prefer two non-splinted implants.

A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site

2018 ◽  
Vol 25 (6) ◽  
pp. 871-875 ◽  
Author(s):  
Cinda L Hugos ◽  
Michelle H Cameron ◽  
Zunqiu Chen ◽  
Yiyi Chen ◽  
Dennis Bourdette
Keyword(s):  
Controlled Trial ◽  
Control Program ◽  
Group Program ◽  
Delayed Effect ◽  
Randomized Controlled ◽  
Impact Scale ◽  
Multicenter Randomized Controlled Trial ◽  
Fatigue Impact Scale

Background: A four-site RCT of Fatigue: Take Control (FTC), a multicomponent group program, found no significant differences from a control program, MS: Take Control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. Objective: Assess FTC for a delayed effect on fatigue. Methods: Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. Results: Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC −8.9 (confidence interval (CI): 32.2, 45), MSTC −2.5 (CI 39.6, 47.7), p = 0.03) at 12 months. Conclusion: The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.

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