Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures

Ventral Hernia Clinical Trial

Official title:

Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04787874
• Other study ID #: 60419
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: June 2, 2025

Study information

• Verified date: December 2021
• Source: Stanford University
• Contact: Cara Black, PGY-2
• Phone: 650-723-7001
• Email: carablack[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: June 2, 2025
• Est. primary completion date: May 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominoplasty
• Flap Reconstruction
• Hernia, Ventral
• Panniculus
• Ventral Hernia

Intervention

Behavioral:
• Prehabilitation Program
Nutrition component: Participants will receive information on how to follow a healthy diet (Mediterranean-style diet) with emphasis on whole foods, plants, lean protein, olive oil; restriction of red meats, processed meats, processed foods, added sugar) Exercise component: Participants will receive an activity tracker to use during the study period (3+ weeks before surgery, and 30 days after surgery). Participants will be assigned strength exercises to work on core strength and proximal muscle strength (biceps/triceps, quads, hamstrings, calves).The exercises will mainly be focused on strengthening the abdominal wall. Exercises will be tailored to patients' individual capabilities. They will also be assigned cardio exercises - either low-intensity steady state cardio vs High Intensity Interval training. Level of cardio exercise will be tailored based on patient's Duke Activity score and baseline activity.

Locations

Country	Name	City	State
United States	Stanford Cancer Center South Bay	San Jose	California
United States	Stanford Plastic and Reconstructive Surgery Clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of surgical complications (Post-op days 7-14)	Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.	Post-operative days 7-14
Primary	Occurrence of surgical complications (Post-op day 30)	Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.	Post-operative day 30
Primary	Occurrence of surgical complications (Post-op day 90)	Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.	Post-operative day 90
Primary	Occurrence of surgical complications (Post-op day 180)	Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.	Post-operative day 180
Primary	Occurrence of surgical complications (Post-op day 360)	Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.	Post-operative day 360
Primary	Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.	Post-operative days 7-14
Primary	Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.	Post-operative days 7-14
Primary	Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.	Post-operative day 30
Primary	Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.	Post-operative day 30
Primary	Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.	Post-operative day 90
Primary	Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.	Post-operative day 90
Primary	Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.	Post-operative day 180
Primary	Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.	Post-operative day 180
Primary	Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.	Post-operative day 360
Primary	Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.	Post-operative day 360
Primary	Physical Function Test: 6-minute walk test at 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.	Time of enrollment
Primary	Physical Function Test: 5-times-sit-to-stand test at 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.	Time of enrollment
Primary	Physical Function Test: Timed-up-and-go test at 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.	Time of enrollment
Primary	Physical Function Test: 6-minute walk test at 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.	3 weeks
Primary	Physical Function Test: 5-times-sit-to-stand test at 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.	3 weeks
Primary	Physical Function Test: Timed-up-and-go test at 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.	3 weeks
Primary	Physical Function Test: 6-minute walk test on Post-op 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.	Post-operative day 30
Primary	Physical Function Test: 5-times-sit-to-stand-test on Post-op 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.	Post-operative day 30
Primary	Physical Function Test: Timed-up-and-go test on Post-op 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.	Post-operative day 30
Primary	Physical Function Test: 6-minute walk test on Post-op 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.	Post-operative day 90
Primary	Physical Function Test: 5-times-sit-to-stand test on Post-op 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.	Post-operative day 90
Primary	Physical Function Test: Timed-up-and-go test on Post-op 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.	Post-operative day 90
Secondary	Change from Baseline Albumin Levels at Time of Surgery	To analyze nutritional status	Enrollment to time of surgery
Secondary	Change from Baseline Prealbumin Levels at Time of Surgery	To analyze nutritional status	Enrollment to time of surgery
Secondary	Change from Baseline Transferrin Levels at Time of Surgery	To analyze nutritional status	Enrollment to time of surgery
Secondary	Change from Baseline C-reactive Protein Levels at Time of Surgery	To analyze level of physiologic inflammation	Enrollment to time of surgery
Secondary	Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery	To analyze level of physiologic inflammation	Enrollment to time of surgery
Secondary	Change from Baseline Hemoglobin A1C Levels at Time of Surgery	To analyze degree of diabetes mellitus control	Enrollment to time of surgery
Secondary	Change from Baseline Plasma Glucose Levels at Time of Surgery	To analyze degree of diabetes mellitus control	Enrollment to time of surgery
Secondary	Change from Baseline White Blood Cell Count at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.	Enrollment to time of surgery
Secondary	Change from Baseline Hemoglobin Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.	Enrollment to time of surgery
Secondary	Change from Baseline Hematocrit Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.	Enrollment to time of surgery
Secondary	Change from Baseline Platelet Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.	Enrollment to time of surgery
Secondary	Change from Baseline Chloride Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery
Secondary	Change from Baseline Sodium Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery
Secondary	Change from Baseline Potassium Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery
Secondary	Change from Baseline Carbon Dioxide Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery
Secondary	Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery
Secondary	Change from Baseline Creatinine Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery
Secondary	Change from Baseline Blood Glucose Levels at Time of Surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel	Enrollment to time of surgery