Trial Outcomes & Findings for Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX (NCT NCT02609425)

Last Updated: 2023-11-24

Results Overview

Analysis specific to anastomosis leak will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

5-7 Days to assess anastomotic integrity

Results posted on

2023-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	All Participipants All patients enrolled on the study.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=30 Participants All patients enrolled on the study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	25 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Region of Enrollment: United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5-7 Days to assess anastomotic integrity

Population: Data were not collected

Analysis specific to anastomosis leak will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5-7 days to assess anastomotic integrity

Population: Data were not collected

Analysis specific to anastomosis stricture will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Meehan

Henry Ford Health System

Phone: 313-916-9387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place