Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventral Hernia
- Sponsor
- Stanford University
- Enrollment
- 520
- Locations
- 2
- Primary Endpoint
- Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the abdomen improves surgical outcomes. The investigators hope to determine how a multimodal peri-operative prehabilitation program can be most effective in engaging and motivating patients to physically and mentally get ready for an abdominally-based plastic surgery operation. The overall goal is to determine if this program will improve post-operative recovery after abdominally-based plastic surgery. The importance of this new knowledge is better understanding of ways that plastic surgeons can improve outcomes, engagement, and experience of patients undergoing abdominally-based plastic surgery operations. This would translate to increased healthcare value and better long-term outcomes.
Investigators
Cara Black
Resident Physician, PGY-1
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Adult patients (\>18 years) who are undergoing elective abdominally-based plastic surgery operations in 3+ weeks by one of the following plastic surgeons: Nazerali, Lee, Murphy, Nguyen, Lorenz.
Exclusion Criteria
- •Patients who do not speak English
- •Patients who do not have access to a smartphone or internet/cell service.
- •Patients who are undergoing another intervention study that consists of a nutrition and/or exercise behavior change.
Outcomes
Primary Outcomes
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14
Time Frame: Post-operative days 7-14
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 30
Time Frame: Post-operative day 30
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 30
Time Frame: Post-operative day 30
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Occurrence of surgical complications (Post-op days 7-14)
Time Frame: Post-operative days 7-14
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 30)
Time Frame: Post-operative day 30
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 90)
Time Frame: Post-operative day 90
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 180)
Time Frame: Post-operative day 180
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 360)
Time Frame: Post-operative day 360
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op days 7-14
Time Frame: Post-operative days 7-14
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 90
Time Frame: Post-operative day 90
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 90
Time Frame: Post-operative day 90
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 180
Time Frame: Post-operative day 180
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 180
Time Frame: Post-operative day 180
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Physical Function Test: 5-times-sit-to-stand test on Post-op Day 90
Time Frame: Post-operative day 90
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 360
Time Frame: Post-operative day 360
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 360
Time Frame: Post-operative day 360
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Physical Function Test: 6-minute walk test at Time of Enrollment
Time Frame: Time of enrollment
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand test at Time of Enrollment
Time Frame: Time of enrollment
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test at Time of Enrollment
Time Frame: Time of enrollment
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Physical Function Test: 6-minute walk test at 3 weeks
Time Frame: 3 weeks
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand test at 3 weeks
Time Frame: 3 weeks
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test at 3 weeks
Time Frame: 3 weeks
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Physical Function Test: 6-minute walk test on Post-op Day 30
Time Frame: Post-operative day 30
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand-test on Post-op Day 30
Time Frame: Post-operative day 30
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test on Post-op Day 30
Time Frame: Post-operative day 30
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Physical Function Test: 6-minute walk test on Post-op Day 90
Time Frame: Post-operative day 90
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: Timed-up-and-go test on Post-op Day 90
Time Frame: Post-operative day 90
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Secondary Outcomes
- Change from Baseline Albumin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Prealbumin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Transferrin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline C-reactive Protein Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Hemoglobin A1C Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Plasma Glucose Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline White Blood Cell Count at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Hemoglobin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Hematocrit Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Platelet Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Chloride Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Sodium Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Potassium Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Carbon Dioxide Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Creatinine Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Blood Glucose Levels at Time of Surgery(Enrollment to time of surgery)