Trial Outcomes & Findings for Phase II Study for Robot Assisted Distal Gastrectomy (NCT NCT01504997)

Results Overview

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Participants will be followed for the duration of hospital stay, an expected average of 10 days

Results posted on

2016-11-29

Participant Flow

A total of 23 patients were recruited for the study, and the initial 5 cases were excluded from the primary analysis because some of the initial RAGs were performed by invited surgeons who had lots of experience. This exclusion was prespecified in the protocol. Therefore, only the remaining 18 patients were included in the analysis.

Participant milestones

Participant milestones
Measure	Robot Assisted Distal Gastrectomy patients who received robot assisted distal gastrectomy Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study for Robot Assisted Distal Gastrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robot Assisted Distal Gastrectomy n=18 Participants patients who received robot assisted distal gastrectomy Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	65.5 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Japan	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 10 days

Outcome measures

Outcome measures
Measure	Robot Assisted Distal Gastrectomy n=18 Participants patients who received robot assisted distal gastrectomy Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy
The Incidence of Post-operative Intra-abdominal Infectious Complications	0 participants Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the surgery, an expected average of 5 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 10 days

Outcome measures

Outcome data not reported

Adverse Events

Robot Assisted Distal Gastrectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Doctor Masanori Tokunaga

Shizuoka Cancer Center

Phone: 81-55098908777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place