An interventional study of Prehabilitation Program in Ventral Hernia, Panniculus and Abdominoplasty, sponsored by Stanford University. Recruiting at 2 sites in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 520 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Occurrence of surgical complications (Post-op days 7-14)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-operative day 90
Change from Baseline Albumin Levels at Time of Surgery
To analyze nutritional status
Time frame: Enrollment to time of surgery
Change from Baseline Prealbumin Levels at Time of Surgery
To analyze nutritional status
Time frame: Enrollment to time of surgery
Change from Baseline Transferrin Levels at Time of Surgery
To analyze nutritional status
Time frame: Enrollment to time of surgery
Change from Baseline C-reactive Protein Levels at Time of Surgery
To analyze level of physiologic inflammation
Time frame: Enrollment to time of surgery
Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery
To analyze level of physiologic inflammation
Time frame: Enrollment to time of surgery
Change from Baseline Hemoglobin A1C Levels at Time of Surgery
To analyze degree of diabetes mellitus control
Time frame: Enrollment to time of surgery
Change from Baseline Plasma Glucose Levels at Time of Surgery
To analyze degree of diabetes mellitus control
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Enrollment to time of surgery
Plan to share: No
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