Table 2 Trial schedule of enrolment, intervention and assessments, as recommended by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). M months, D day, LSG laparoscopic sleeve gastrectomy, GIQLI Gastrointestinal Quality of Life Index
Study period | ||||||
|---|---|---|---|---|---|---|
Enrolment | Allocation | Follow-up | ||||
Timepoint | M-2 to D-1 | D0 | M3 | M6 | M12 | M24 |
Enrolment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Baseline characteristics | X | |||||
Allocation | X | |||||
Interventions | ||||||
LSG with experimental bougie | X | |||||
LSG with standard care bougie | X | |||||
Assessments | ||||||
Postoperative gastric leak | X | |||||
Global morbidity | X | |||||
Weight | X | X | X | X | X | |
GIQLI questionnaire | X | X | X | X | ||