Clinical trial NCT04787874: Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures
Official title: Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Panniculus
Abdominoplasty
Flap Reconstruction
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 520
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Occurrence of surgical complications (Post-op days 7-14)
timeFrame: Post-operative days 7-14
measure: Occurrence of surgical complications (Post-op day 30)
timeFrame: Post-operative day 30
measure: Occurrence of surgical complications (Post-op day 90)
timeFrame: Post-operative day 90
measure: Occurrence of surgical complications (Post-op day 180)
timeFrame: Post-operative day 180
measure: Occurrence of surgical complications (Post-op day 360)
timeFrame: Post-operative day 360
measure: Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op days 7-14
timeFrame: Post-operative days 7-14
measure: Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14
timeFrame: Post-operative days 7-14
measure: Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 30
timeFrame: Post-operative day 30
measure: Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 30
timeFrame: Post-operative day 30
measure: Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 90
timeFrame: Post-operative day 90
measure: Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 90
timeFrame: Post-operative day 90
measure: Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 180
timeFrame: Post-operative day 180
measure: Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 180
timeFrame: Post-operative day 180
measure: Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 360
timeFrame: Post-operative day 360
measure: Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 360
timeFrame: Post-operative day 360
measure: Physical Function Test: 6-minute walk test at Time of Enrollment
timeFrame: Time of enrollment
measure: Physical Function Test: 5-times-sit-to-stand test at Time of Enrollment
timeFrame: Time of enrollment
measure: Physical Function Test: Timed-up-and-go test at Time of Enrollment
timeFrame: Time of enrollment
measure: Physical Function Test: 6-minute walk test at 3 weeks
timeFrame: 3 weeks
measure: Physical Function Test: 5-times-sit-to-stand test at 3 weeks
timeFrame: 3 weeks
measure: Physical Function Test: Timed-up-and-go test at 3 weeks
timeFrame: 3 weeks
measure: Physical Function Test: 6-minute walk test on Post-op Day 30
timeFrame: Post-operative day 30
measure: Physical Function Test: 5-times-sit-to-stand-test on Post-op Day 30
timeFrame: Post-operative day 30
measure: Physical Function Test: Timed-up-and-go test on Post-op Day 30
timeFrame: Post-operative day 30
measure: Physical Function Test: 6-minute walk test on Post-op Day 90
timeFrame: Post-operative day 90
measure: Physical Function Test: 5-times-sit-to-stand test on Post-op Day 90
timeFrame: Post-operative day 90
measure: Physical Function Test: Timed-up-and-go test on Post-op Day 90
timeFrame: Post-operative day 90
Secondary outcomes:
measure: Change from Baseline Albumin Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Prealbumin Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Transferrin Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline C-reactive Protein Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Hemoglobin A1C Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Plasma Glucose Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline White Blood Cell Count at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Hemoglobin Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Hematocrit Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Platelet Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Chloride Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Sodium Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Potassium Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Carbon Dioxide Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Creatinine Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
measure: Change from Baseline Blood Glucose Levels at Time of Surgery
timeFrame: Enrollment to time of surgery
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Stanford Cancer Center South Bay
state: California
city: Stanford
country: United States
facility: Stanford Plastic and Reconstructive Surgery Clinic
state: California
Study officials:
affiliation: Asst Prof-Med Ctr Line
name: Cindy Kin, MD
role: STUDY_DIRECTOR
affiliation: Resident
name: Cara Black, MD
role: PRINCIPAL_INVESTIGATOR
References: