Decreasing operative time and incontinence rates in patients treated with radical cystectomy and urethral diversion: a prospective randomized trial using a new suturing device (CAPIO)

4545 Background: High risk locally advanced bladder cancer patients experienced low survival rates, high local recurrence and extensive distant metastasis. Postoperative radiotherapy (PORT) though improved the survival through improving local control. Methods: A prospective randomized trial was performed at NCI, Cairo, Egypt including 142 patients in 2 arms. Patients who underwent radical cystectomy and pelvic lymphadenectomy had to have one more of the following: P3b or P4a stage, G3 or involved lymphadenopathy. Arm I (71 patients) received PORT 45 G/30 fractions/3 weeks. Arm II (71 patients) received 2 courses of adjuvant chemotherapy (Gemcitabine 1 gm/m2 D1 and D8 and cisplatin 70 mg/m2 D2), same PORT regimen followed by another 2 courses of Gemcitabine-cisplatin. Results: Chemotherapy was tolerated with grade 1/2 toxicities. Early radiation reactions were also tolerable in both arms, slightly more in arm II. Delayed toxicity was comparable in both arms. The 2-year DFS was 67.6 ± 5.9% in the whole group. This was affected significantly by performance status (p = 0.009), pathological stage (p = 0.001), tumor cell type (p = 0.053), nodal involvement (p = 0.07) and number of risk factors (p = 0.09). Though there was improvement of DFS from 61.5 ± 7.4% in PORT group to 70.9 ± 6.1% in chemoradiotherapy group, yet it was not statistically significant (p = 0.2). Patients having one risk factor, low pathological stage or no nodal involvement in arm II experienced better DFS than those in arm I (p = 0.07, 0.08 and 0.09 respectively). Conclusions: Adjuvant chemoradiotherapy using Gemcitabine-cisplatin and PORT was tolerable with minimal severe toxicities. There was DFS improvement with the addition of chemotherapy to PORT (not statistically significant yet). Patients with one risk factor, lower pathological stage or no nodal involvement seemed to benefit more from added chemotherapy. No significant financial relationships to disclose.

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The Safety and Efficacy of Cervical Laminectomy and Fusion versus Cervical Laminoplasty Surgery in Degenerative Cervical Myelopathy: A Prospective Randomized Trial

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2020.4841 ◽

2020 ◽

Vol 8 (B) ◽

pp. 807-814

Author(s):

Mohamed Elmallawany ◽

Haitham Kandel ◽

Mohamed A. R. Soliman ◽

Tarek Ahmed Tareef ◽

Ahmed Atallah ◽

...

Keyword(s):

Hospital Stay ◽

Randomized Trial ◽

Operative Time ◽

Prospective Randomized Trial ◽

Cervical Laminectomy ◽

Significant Difference ◽

Operative Complications ◽

Cobb’S Angle ◽

The Mean ◽

Degenerative Cervical Myelopathy

BACKGROUND: There is a lack of evidence of whether degenerative cervical myelopathy (DCM) is best treated through cervical laminoplasty (CLP) or cervical laminectomy with lateral mass fusion due to the lack of prospective randomized studies that are well designed. We conducted the largest prospective randomized trial to date to determine the comparative effectiveness and safety of both approaches. METHODS: In this prospective, randomized trial, we randomly assigned patients who had symptoms or signs of DCM to undergo either cervical laminectomy and lateral mass fixation (CLF) or CLP. The primary outcome measures were the change in the Visual Analog Scale (VAS), neck disability index, modified Japanese Orthopedic Association (mJOA) score, and Nurick’s myelopathy grading 1 year after surgery. The secondary outcome measures were the intraoperative, post-operative complications, hospital stay, C2-7 Cobb’s angle, and Odom’s criteria. The follow-up period was at least 1 year. RESULTS: A total of 30 patients (mean age, 54.5 ± 5.5 years, 70% of men) underwent prospective randomization. There was a significantly greater improvement in neck pain (VAS) in the CLF group at 1 year (p < 0.05). The improvement in the mJOA and Nurick’s myelopathy grading showed insignificant improvement between both groups. Furthermore, there was no significant difference in the patient’s post-operative satisfaction (Odom’s criteria). The mean operative time was significantly longer in the CLF group (p < 0.001), with no significant difference in the post-operative complications, however, there was a higher rate of C5 palsy, dural tear and infection in the CLF, and a higher rate of instrumentation failure in the CLP. The mean hospital stay was significantly longer in the posterior group (p < 0.05). Finally, there was a significant better improvement in the C2-7 Cobb’s angle at 1 year in the CLF group (p < 0.05). CONCLUSION: Among patients with multilevel DCM, the CLF approach was significantly better regarding the post-operative pain and Cobb’s angle while the CLP was significantly better in terms of shorter hospital stay and operative time.

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