Ventral HerniaNCT04787874
Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures
A study testing Prehabilitation Program in people with Ventral Hernia and Panniculus, run by Stanford University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia, Panniculus, Abdominoplasty
- What is being tested?
- Prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2021to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Stanford Cancer Center South Bay
San Jose, California, 95124
Rahim Nazerali, MD, MHS
- Recruiting
Stanford Plastic and Reconstructive Surgery Clinic
Stanford, California, 94304
Rahim Nazerali, MD, MHS
About this study
Official title: 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.
- Conditions
- Ventral Hernia, Panniculus, Abdominoplasty, Flap Reconstruction
- Being tested
- Prehabilitation Program
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of surgical complications (Post-op days 7-14)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-operative day 90
Secondary outcomes (18)
Change from Baseline Albumin Levels at Time of Surgery
To analyze nutritional status
Measured: Enrollment to time of surgery
Change from Baseline Prealbumin Levels at Time of Surgery
To analyze nutritional status
Measured: Enrollment to time of surgery
Change from Baseline Transferrin Levels at Time of Surgery
To analyze nutritional status
Measured: Enrollment to time of surgery
Change from Baseline C-reactive Protein Levels at Time of Surgery
To analyze level of physiologic inflammation
Measured: Enrollment to time of surgery
Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery
To analyze level of physiologic inflammation
Measured: Enrollment to time of surgery
Change from Baseline Hemoglobin A1C Levels at Time of Surgery
To analyze degree of diabetes mellitus control
Measured: Enrollment to time of surgery
Change from Baseline Plasma Glucose Levels at Time of Surgery
To analyze degree of diabetes mellitus control
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Enrollment to time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start21 Jun 2021
- Primary completion23 May 2025 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Black, Stanford University
- Investigators
- Cindy Kin, MD, Study director, Asst Prof-Med Ctr LineCara Black, MD, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787874
- Sponsor's protocol ID
- 60419
- Status last verified
- Dec 2021
- First submitted
- 1 Mar 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT04787874
- Acronym / sponsor ID
- 60419
- Conditions
- Ventral Hernia, Panniculus, Abdominoplasty, Flap Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Prehabilitation ProgramThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation ProgramNutrition 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. | Behavioural | Prehab Intervention Arm |
Primary outcome
Occurrence of surgical complications (Post-op days 7-14)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14
Time frame: 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
Time frame: 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
Time frame: 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.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 90
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 frame: 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 frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
18 secondary outcomes
Change from Baseline Albumin Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Prealbumin Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Transferrin Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline C-reactive Protein Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Hemoglobin A1C Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Plasma Glucose Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline White Blood Cell Count at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Hemoglobin Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Hematocrit Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Platelet Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Chloride Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Sodium Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Potassium Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Carbon Dioxide Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Creatinine Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Change from Baseline Blood Glucose Levels at Time of Surgery
Time frame: Enrollment to time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Ventral Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Kin, MD study director
Asst Prof-Med Ctr Line
Cara Black, MD principal investigator
Resident
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Program in people with Ventral Hernia and Panniculus, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cara Black, PGY-2 (650-723-7001, carablack@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of surgical complications (Post-op days 7-14) (time frame: Post-operative days 7-14). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.