[Planning and data analysis in prospective controlled clinical trials (author's transl)]

Area of Science:

• Surgical research methodology
• Clinical trial design
• Biostatistics in medicine

Background:

• Effective planning of prospective controlled clinical trials is essential in surgery.
• Key elements include control groups, frequent repetitions, and random patient allocation.
• Balancing of groups is also a critical consideration.

Purpose of the Study:

• To outline essential components for planning robust surgical clinical trials.
• To detail appropriate methods for descriptive data analysis in surgical research.
• To highlight the benefits of specific statistical approaches and the role of experimental surgeons.

Main Methods:

• Utilizing test and control groups for comparative analysis.
• Implementing random allocation of patients to study groups.
• Performing stepwise descriptive data analysis including median, quartiles, and standard deviation.

Main Results:

• The median-quartile system offers advantages for data analysis in clinical trials.
• Specific prerequisites for applying various significance tests are identified.
• A structured approach to data analysis ensures reliable trial outcomes.

Conclusions:

• Rigorous methodology, including randomization and appropriate statistical analysis, underpins successful surgical trials.
• The median-quartile system is recommended for descriptive analysis.
• Consultative input from experimental surgeons is proposed to enhance trial conduct.