Here is the design of a clinical trial:

Official Title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years

Included conditions:
- Colonic Cancer

Study Armgroups:
- {'label': 'Laparotomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Open surgery', 'interventionNames': ['Procedure: Laparotomy']}
- {'label': 'Laparoscopy', 'type': 'EXPERIMENTAL', 'description': 'Minimally invasive surgery', 'interventionNames': ['Procedure: Laparoscopy']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Laparotomy', 'description': 'Open surgery', 'armGroupLabels': ['Laparotomy'], 'otherNames': ['Open surgery']}
- {'type': 'PROCEDURE', 'name': 'Laparoscopy', 'description': 'Minimally invasive surgery', 'armGroupLabels': ['Laparoscopy'], 'otherNames': ['Minimally invasive surgery']}

Primary Outcomes:
- {'measure': 'Global postoperative morbidity in both arms', 'description': 'Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then', 'timeFrame': 'At 30 days after the surgery'}

Please estimate the sample size based on the assumption: 
The study uses a two-sided alpha risk of 5% and a power of 80% (beta = 0.20). No interim analysis will be performed. Statistical significance is considered for two-tailed P-values <0.05.
Statistical analysis and sample size
        This study is multicenter, open-label randomized, 2-arm phase III superiority trial, comparing arm A (colectomy by laparoscopy) versus arm B (colectomy by laparotomy) for patients aged 75âyears old or more with uncomplicated colon cancer. The hypotheses for sample size calculation are: (i) H0: there is no difference in overall postoperative morbidity between the two arms; (ii) H1: there is a significant difference, with estimated global morbidities in the laparoscopy and laparotomy groups of 20 and 35%, respectively. With a two-sided Î± risk of 5% and a power of 80% (Î²â=â0.20) as alternative hypothesis H1, 276 patients will be included in total (138 patients in each arm). No interim analysis will be performed. The endpoints will be analyzed according to the intention-to-treat principle, in such a way that patients who did not receive their allocated surgical procedure were analyzed in the treatment group to which they had been randomized. An additional as-treated analysis will also be done, taking into account intraoperative conversions to the open-surgery group.
        Continuous variables will be described via the mean, standard deviation, median, minimum and maximum. Categorical variables will be described using frequencies and percentages. The percentages will be calculated with the missing data item. 95% confidence intervals (95% CI) will be calculated when necessary.
        Percentage differences between groups will be compared with the Pearsonâs Ï2 test or Fisherâs exact test, as appropriate. Comparison of continuous data will be done by use of the Studentâs t test or the nonparametric Mann-Whitney U test, depending on their distribution. Two-tailed P-values <0.05 will be considered statistically significant.
        Quality of life will be described preoperatively and 3âmonths postoperatively in both treatment arms. Rate of patients having a QLQ-C30 or QLQ-CR29 score improved, deteriorated or stabilized at the second quality of life assessment will be reported in each arm with frequency and percent. The weighted means at baseline (preoperative score) and at 3âmonths will be compared in each arm using the Wilcoxonâs signed-rank test. Based on the study by Osoba and colleagues [32], this analysis will be limited to domains showing a difference of at least 10 points between the two assessments, which can be interpreted as a clinically important change. Mean quality of life changes from baseline will be computed in each arm with 95% CI. The weighted mean differences between both arms will be compared using the nonparametric Mann-Whitney U test.