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

NCT04787874 | Unknown

• 1 other identifier: 60419
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventral Hernia; Panniculus; Abdominoplasty; Flap Reconstruction

Outcome Measures

Primary Outcomes (27)

• 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 Outcomes (18)

• 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

Study Arms (2)

Control

NO INTERVENTION

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.

Prehab Intervention Arm

EXPERIMENTAL

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

Interventions

Prehabilitation Program BEHAVIORAL

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.

Prehab Intervention Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford Cancer Center South Bay

San Jose, California, 95124, United States

RECRUITING

Stanford Plastic and Reconstructive Surgery Clinic

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Cindy Kin, MD

  Asst Prof-Med Ctr Line

  STUDY DIRECTOR

• Cara Black, MD

  Resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Black, PGY-2

CONTACT

650-723-7001; carablack@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, PGY-1

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 9, 2021
• Study Start: June 21, 2021
• Primary Completion: May 23, 2025
• Study Completion: June 2, 2025
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)