Trial Outcomes & Findings for Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism (NCT NCT05034081)
NCT ID: NCT05034081
Last Updated: 2026-05-01
Results Overview
to know the effect of post-bariatric body contouring surgery in weight. Detect the weight cahnges of the patient 3 and 6 months after body contouring surgery and body mass index also measured
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Group A
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
Baseline characteristics by cohort
| Measure |
Group A
n=30 Participants
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 Participants
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=14 Participants
|
30 Participants
n=34 Participants
|
60 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 10 • n=14 Participants
|
41 years
STANDARD_DEVIATION 11 • n=34 Participants
|
41 years
STANDARD_DEVIATION 10.5 • n=69 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=14 Participants
|
17 Participants
n=34 Participants
|
40 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
13 Participants
n=34 Participants
|
20 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=14 Participants
|
30 Participants
n=34 Participants
|
60 Participants
n=69 Participants
|
|
Region of Enrollment
Egypt
|
30 participants
n=14 Participants
|
30 participants
n=34 Participants
|
60 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 6 monthsto know the effect of post-bariatric body contouring surgery in weight. Detect the weight cahnges of the patient 3 and 6 months after body contouring surgery and body mass index also measured
Outcome measures
| Measure |
Group A
n=30 Participants
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 Participants
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Weight Changes by Kilograms
Pre operative weight
|
94.3 Kilo gram
Standard Deviation 12.41
|
96.17 Kilo gram
Standard Deviation 6.7
|
|
Weight Changes by Kilograms
3 months after body contouring
|
96.27 Kilo gram
Standard Deviation 6.87
|
89.4 Kilo gram
Standard Deviation 12.44
|
|
Weight Changes by Kilograms
6 months after body contouring
|
96.67 Kilo gram
Standard Deviation 6.93
|
86.3 Kilo gram
Standard Deviation 12.08
|
PRIMARY outcome
Timeframe: 6 monthsIts a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. Tumor necrotizing factor alfa increase afer bariatric surgery and we want to know if its complete on increasing after body contouring surgeries or decresae . Tnf-a is measured by pg/ml
Outcome measures
| Measure |
Group A
n=30 Participants
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 Participants
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Level of Tumor Necrotizing Factor Alfa in Blood
Pre operative tnf alfa
|
8.61 Pico gram per ml
Standard Deviation 1.56
|
9.07 Pico gram per ml
Standard Deviation 2
|
|
Level of Tumor Necrotizing Factor Alfa in Blood
3 months after body contouring
|
5.84 Pico gram per ml
Standard Deviation 1.43
|
6.93 Pico gram per ml
Standard Deviation 1.35
|
|
Level of Tumor Necrotizing Factor Alfa in Blood
6 months after body contouring
|
5.3 Pico gram per ml
Standard Deviation 1.76
|
6.86 Pico gram per ml
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: 6 monthsIts a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. BNP highly increase with catabolism after bariatric surgery and we want to know the effect of body contouring surgeries in the level of BNP. BNP unit is pg/ml
Outcome measures
| Measure |
Group A
n=30 Participants
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 Participants
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Level of BNP in Blood
Pre operative BNP
|
64 Pico gram per ml
Standard Deviation 18.78
|
59.03 Pico gram per ml
Standard Deviation 18.13
|
|
Level of BNP in Blood
3 months after body contouring
|
63.4 Pico gram per ml
Standard Deviation 17.71
|
70.07 Pico gram per ml
Standard Deviation 19.14
|
|
Level of BNP in Blood
6 months after body contouring
|
69.33 Pico gram per ml
Standard Deviation 18.13
|
75.13 Pico gram per ml
Standard Deviation 19.01
|
PRIMARY outcome
Timeframe: 6 monthsIts a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. hsCRP increase with catabolism after bariatric surgery and we want to know the effect of body contouring surgeries in blood level of hsCRp. The unit of hsCRP is mg/dl.
Outcome measures
| Measure |
Group A
n=30 Participants
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 Participants
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Level of High Sensitive CRP in Blood
Pre operative hscrp
|
1.13 Mg per dl
Standard Deviation 0.75
|
1.23 Mg per dl
Standard Deviation 1
|
|
Level of High Sensitive CRP in Blood
3 months after body contouring
|
0.93 Mg per dl
Standard Deviation 0.54
|
0.58 Mg per dl
Standard Deviation 0.36
|
|
Level of High Sensitive CRP in Blood
6 months after body contouring
|
0.87 Mg per dl
Standard Deviation 0.52
|
0.52 Mg per dl
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: 6 monthsFrom 1 to 5 . 1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction.
Outcome measures
| Measure |
Group A
n=30 Participants
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 Participants
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Patient Satisfaction Score
|
4.2 Scores in scale
Interval 1.0 to 5.0
|
2 Scores in scale
Interval 1.0 to 5.0
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=30 participants at risk
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
body contouring: any post-bariatric body contouring surgery included
|
Group B
n=30 participants at risk
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Echymosis
|
33.3%
10/30 • 6 months
No risky intervention in follow up
|
40.0%
12/30 • 6 months
No risky intervention in follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place