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

Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia; Abdominoplasty; Panniculus; Flap Reconstruction
• Intervention / Treatment: Behavioral: Prehabilitation Program

• Study Type: Interventional
• Enrollment (Anticipated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cara Black, PGY-2; Phone Number: 650-723-7001; Email: carablack@stanford.edu

Study Locations

• United States
  • California
    • San Jose, California, United States, 95124
      • Recruiting
      • Stanford Cancer Center South Bay
      • Contact: Rahim Nazerali, MD, MHS
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford Plastic and Reconstructive Surgery Clinic
      • Contact: Rahim Nazerali, MD, MHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control arm will receive no additional prehabilitation material prior to material. Rather, they will receive standard preoperative care in which they will be given standard advice on nutrition and fitness. REDcap surveys will be administered.
Experimental: Prehab Intervention Arm; The intervention arm will receive access to the prehab program (abdominal workout videos) and surveys via RedCAP.The program will start no less than 14 days before the date of surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Albumin Levels at Time of Surgery	To analyze nutritional status	Enrollment to time of surgery
Change from Baseline Prealbumin Levels at Time of Surgery	To analyze nutritional status	Enrollment to time of surgery
Change from Baseline Transferrin Levels at Time of Surgery	To analyze nutritional status	Enrollment to time of surgery
Change from Baseline C-reactive Protein Levels at Time of Surgery	To analyze level of physiologic inflammation	Enrollment to time of surgery
Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery	To analyze level of physiologic inflammation	Enrollment to time of surgery
Change from Baseline Hemoglobin A1C Levels at Time of Surgery	To analyze degree of diabetes mellitus control	Enrollment to time of surgery
Change from Baseline Plasma Glucose Levels at Time of Surgery	To analyze degree of diabetes mellitus control	Enrollment to time of surgery
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Cindy Kin, MD, Asst Prof-Med Ctr Line; Principal Investigator: Cara Black, MD, Resident

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Anticipated): May 23, 2025
• Study Completion (Anticipated): June 2, 2025

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 60419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No