Trial Outcomes & Findings for Minimally Invasive Surgery (MIS) Database for the Purpose of Research (NCT NCT00535990)

Results Overview

Post-operative outcomes including: 30 day morbidity 30 day mortality 30 day readmission Surgical site infection Surgical site occurrences Surgical Reintervention Specific Surgical outcomes (staple line leak, etc)

Recruitment status

COMPLETED

Target enrollment

250 participants

Primary outcome timeframe

1 year

Results posted on

2021-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Surgical Intervention All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
Overall Study STARTED	250
Overall Study COMPLETED	250
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minimally Invasive Surgery (MIS) Database for the Purpose of Research

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Intervention n=250 Participants All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	175 Participants n=5 Participants
Age, Categorical >=65 years	75 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Post-operative outcomes including: 30 day morbidity 30 day mortality 30 day readmission Surgical site infection Surgical site occurrences Surgical Reintervention Specific Surgical outcomes (staple line leak, etc)

Outcome measures

Outcome measures
Measure	Surgical Intervention n=250 Participants All patients in the minimally invasive surgery database are patients who have undergone surgical intervention by the Minimally Invasive Surgery faculty. Patients can be further stratified based on the type of procedure that they received. Since this study is primarily creation of a comprehensive database, patient's are not intentionally placed in a certain study arm aside from their procedure type.
Post Operative Outcomes 30 day morbidity	27 participants
Post Operative Outcomes 30 day mortality	0 participants
Post Operative Outcomes 30 day readmission	6 participants
Post Operative Outcomes surgical site infection	4 participants

Adverse Events

Surgical Intervention

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

Dr. Jonathan Li

UCSD

Phone: 6618603471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place