The sponsor in collaboration with the Steering Committee decided not to establish a formal Data Monitoring Committee for this trial considering the following 5 points:

This trial aims to evaluate the uselessness of prophylactic drain placement after gastrectomy, a clinical practice that is still widely used but that has been already been discouraged by international guidelines

Evidence in literature does not suggest a highly favorable or unfavorable result. The design of a non-inferiority trial was deemed necessary due to the small estimated difference between the two groups on the outcome considered for this study

The inclusion criteria and the study design (leaving the decision on the POD of drain removal to each participating center according to their usual clinical practice) consistently reduce the (already limited) risks

Allowing any type of drain in the study protocol (leaving the decision to each center according to their usual clinical practice) does not define this study as a device study

Patient population is above 18 years old

All the participating centers are part of GIRCG quality of surgery and postoperative care was considered adequate for this trial according to our previous studies [25, 26].

The wide inclusion criteria and the balancing between type of resection aim to result in a trial as close as possible to the everyday Western clinical practice.

Considering that both arms include treatment commonly applied in daily clinical practice (drain placement and drain avoidance) under the inclusion criteria considered in this trial, the IRBs (of each participating center), in accordance with the legal service of all the participating center, agreed to ensure ADiGe Trial using the hospital insurance of each center. Therefore, in case of claims for damages, the responsible would be the insurance coverage of assistance activities of the center that recruited and treated the patient.

Any untoward medical occurrence in a patient without regard to the possibility of a causal relationship has been defined as an adverse event (AE). Investigators from each participating center will record any AE from the day of operation until the end of the observation period. All AEs will be documented in the patient’s medical record and AE form including any workup or treatment needed and grading (according to the Common Terminology Criteria for Adverse Events), according to everyday clinical practice.

AE, expected to be related with the study treatment (bleeding from drain site, skin infection around the drain site and pain), will be also recorded in the study CRF. Any unexpected AE, considered by the investigator as causally related with the treatment, will be recorded in the study CRF and reported to the steering committee for safety reporting purposes.

AE that meets the following criteria will be recorded as serious adverse event (SAE): life-threatening condition (immediate risk of death), severe or permanent disability, and prolonged hospitalization. All SAE will be recorded in the study CRF. Moreover, the investigators will report to the local IRB and the steering committee, as soon as possible, but in no event later than 2 working days, any SAE that is deemed by the local investigator to be probably or definitely related to the study treatment. The steering committee will then review the report and send it to the promoting center’s IRB within 2 working days. SAEs, occurring after a patient is discontinued from the study, will not be reported unless the investigators will determine that they are related to the study treatment. If the number of SAE is higher than reported in the recently published Gastrodata study on complications after gastrectomy [27], patient enrollment will be terminated immediately, and the steering committee will reassess the safety of the trial.

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