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

Not Applicable

Recruiting

• Conditions: Panniculus; Abdominoplasty; Flap Reconstruction; Ventral Hernia
• Interventions: Behavioral: Prehabilitation Program

• Registration Number: NCT04787874
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Study Start: 2021-06-21
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15
• Primary Completion: 2025-05-23
• Study Completion: 2025-06-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehab Intervention Arm	Prehabilitation Program	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.

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14	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	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	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)	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)	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)	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)	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)	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	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	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	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	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	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.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 360	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	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 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 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 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	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	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	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	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	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	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	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: 5-times-sit-to-stand test on Post-op Day 90	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.
Physical Function Test: Timed-up-and-go test on Post-op Day 90	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 Outcome Measures

Name	Time	Method
Change from Baseline Albumin Levels at Time of Surgery	Enrollment to time of surgery	To analyze nutritional status
Change from Baseline Prealbumin Levels at Time of Surgery	Enrollment to time of surgery	To analyze nutritional status
Change from Baseline Transferrin Levels at Time of Surgery	Enrollment to time of surgery	To analyze nutritional status
Change from Baseline C-reactive Protein Levels at Time of Surgery	Enrollment to time of surgery	To analyze level of physiologic inflammation
Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery	Enrollment to time of surgery	To analyze level of physiologic inflammation
Change from Baseline Hemoglobin A1C Levels at Time of Surgery	Enrollment to time of surgery	To analyze degree of diabetes mellitus control
Change from Baseline Plasma Glucose Levels at Time of Surgery	Enrollment to time of surgery	To analyze degree of diabetes mellitus control
Change from Baseline White Blood Cell Count at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Change from Baseline Hemoglobin Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Change from Baseline Hematocrit Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Change from Baseline Platelet Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Change from Baseline Chloride Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Change from Baseline Sodium Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Change from Baseline Potassium Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Change from Baseline Carbon Dioxide Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Change from Baseline Creatinine Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Change from Baseline Blood Glucose Levels at Time of Surgery	Enrollment to time of surgery	Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel

Trial Locations

Locations (2)

Stanford Cancer Center South Bay; 🇺🇸 San Jose, California, United States

Stanford Plastic and Reconstructive Surgery Clinic; 🇺🇸 Stanford, California, United States