Examination of the Validity of Skin Ultrasound to Quantitate Skin Involvement for Multicenter Clinical Trials in Patients with Systemic Sclerosis ( SSc ): A Systematic Literature Review ( SLR )

Despite the large number of available surgical interventions aimed at the treatment of rectovaginal fistulas, the results of their use remain extremely disappointing, associated with the high recurrence rate of the disease reaching 80 %, as well as the lack of a single tactic to minimize the risk of anal incontinence and the need for colostomy. Objective: to conduct a systematic literature review in order to summarize information related to the rectovaginal fistulas surgery. The systematic review includes the results of an analysis of 97 clinical trials selected from 756 publications found in databases. Inclusion criteria: a full-text article, the presence of at least 5 patients in the study, as well as data on the outcome of surgery. Clinical trials with different surgical treatments were identified and classified into the following categories: elimination of the rectovaginal septal defect with a displaced flap (rectal and vaginal); Martius surgery; gracilis muscle transposition; transperineal procedure; abdominal procedure including endoscopic and laparoscopic methods; use of biological or biocompatible materials. Treatment outcomes vary significantly from 0 % to > 80 %. None of the studies were randomized. Due to the low quality of the identified studies, comparison of results and meta-analysis conduction were not possible. Conclusion: as a result of the systematic review, data for the analysis and development of any strategic and tactical algorithms for the treatment of RVF were not obtained. The most important questions still remain open: what and when surgical method to choose, is it necessary to form a disconnecting stoma?

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Diarrhea in Placebo Arms of Cancer Studies

Cancer Diagnosis & Prognosis ◽

10.21873/cdp.10050 ◽

2021 ◽

Vol 1 (5) ◽

pp. 379-385

Author(s):

BIRTE J. WOLFF ◽

JOHANNES E. WOLFF

Keyword(s):

Clinical Trials ◽

Literature Review ◽

Adverse Events ◽

Healthy Volunteers ◽

Cancer Prevention ◽

Cancer Patients ◽

Systematic Literature Review ◽

Oncology Clinical Trials ◽

Prevention Studies ◽

Cancer Studies

Background/Aim: Diarrhea is among the most common adverse events in early oncology clinical trials, and drug causality may be difficult to determine. Materials and Methods: This is a systematic literature review of placebo arms of randomized cancer trials. Results: Anemia was reported in 95 of 127 placebo monotherapy cohorts. Publications involving healthy volunteers and cancer prevention studies reported lower frequencies than those with cancer patients. The average reported frequency of diarrhea grade 1 or higher among studies in cancer patients was 15%. The maximal reported frequencies for grades 1, 2, 3, 4, 5 were 56, 24, 6, 2, and 0%, respectively. Conclusion: When higher diarrhea frequencies than those are observed in treatment arms of clinical trials, then drug causality is likely.

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