Trial Outcomes & Findings for Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity (NCT NCT01998243)
NCT ID: NCT01998243
Last Updated: 2019-06-10
Results Overview
postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
within the 90 days after surgery
Results posted on
2019-06-10
Participant Flow
151 patients were eligibles for the study and were evaluated at the endocrinologist office
40 patients rejected to be included in the study and 30 were excluded before randomization for not to fulfill all the established requirement to be included
Participant milestones
| Measure |
Group B
42 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB-BIB® Group A
39 patients included have a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Group B
42 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB-BIB® Group A
39 patients included have a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
missing data
Baseline characteristics by cohort
| Measure |
Group B
n=34 Participants
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
Intragastrc Balloon (IGB) Group A
n=32 Participants
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years OF AGE
STANDARD_DEVIATION 9.2 • n=34 Participants
|
43 years OF AGE
STANDARD_DEVIATION 10.2 • n=32 Participants
|
42.8 years OF AGE
STANDARD_DEVIATION 9.6 • n=66 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=34 Participants
|
21 Participants
n=32 Participants
|
45 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=34 Participants
|
11 Participants
n=32 Participants
|
21 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
66 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Region of Enrollment
Spain
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
66 Participants
n=66 Participants
|
|
Americam Society of Anestesiologist Physical Status Classification System (ASA) ; ASA score III;
|
11 participants
n=34 Participants
|
12 participants
n=32 Participants
|
23 participants
n=66 Participants
|
|
Starting weight (kg)
|
125 Kg
STANDARD_DEVIATION 18.5 • n=34 Participants
|
129.2 Kg
STANDARD_DEVIATION 19.4 • n=32 Participants
|
127.1 Kg
STANDARD_DEVIATION 18.9 • n=66 Participants
|
|
Starting body mass index (starting BMI)
|
46 "kg/m^2"
STANDARD_DEVIATION 4.9 • n=34 Participants
|
46.4 "kg/m^2"
STANDARD_DEVIATION 6.9 • n=32 Participants
|
46.2 "kg/m^2"
STANDARD_DEVIATION 5.7 • n=66 Participants
|
|
Starting body mass index (starting BMI) > 50 ("kg/m^2")
|
8 Participants
n=34 Participants
|
7 Participants
n=32 Participants
|
15 Participants
n=66 Participants
|
|
Total weight loss (TWL)
|
3 Kg
n=34 Participants
|
16 Kg
n=32 Participants
|
7 Kg
n=66 Participants
|
|
Weight before surgery (Kg)
|
121.3 Kg
STANDARD_DEVIATION 20.5 • n=34 Participants
|
112.8 Kg
STANDARD_DEVIATION 16.4 • n=32 Participants
|
117.2 Kg
STANDARD_DEVIATION 19.0 • n=66 Participants
|
|
BMI before surgery("kg/m^2")
|
44.3 "kg/m^2"
STANDARD_DEVIATION 5.5 • n=34 Participants
|
40 "kg/m^2"
STANDARD_DEVIATION 6.2 • n=32 Participants
|
42.2 "kg/m^2"
STANDARD_DEVIATION 5.9 • n=66 Participants
|
|
Excess weight loss (EWL) before surgery
|
4.54 percentage of EWL
n=32 Participants • missing data
|
27.14 percentage of EWL
n=32 Participants • missing data
|
11.1 percentage of EWL
n=64 Participants • missing data
|
|
Excess Body Mass Index Loss (EBMIL) before surgery (excess BMI loss)
|
1 percentage of EBMI loss
n=34 Participants
|
6.04 percentage of EBMI loss
n=32 Participants
|
3 percentage of EBMI loss
n=66 Participants
|
|
Surgery (sleeve resection (LSG)or gastric bypass (LGBP)
LSG
|
11 Participants
n=34 Participants
|
9 Participants
n=32 Participants
|
20 Participants
n=66 Participants
|
|
Surgery (sleeve resection (LSG)or gastric bypass (LGBP)
LGBP
|
23 Participants
n=34 Participants
|
23 Participants
n=32 Participants
|
46 Participants
n=66 Participants
|
|
total body weight loss (TBWL) > 10%
|
4 Participants
n=32 Participants • missing data
|
18 Participants
n=32 Participants • missing data
|
22 Participants
n=64 Participants • missing data
|
|
Percentage of Failure of Intragastric Balloon
|
—
|
11 Participants
n=32 Participants • this variable is not applicable to group B
|
11 Participants
n=32 Participants • this variable is not applicable to group B
|
|
Operation time (hours)
|
2.8 hours
STANDARD_DEVIATION 0.73 • n=32 Participants • missing data
|
2.8 hours
STANDARD_DEVIATION 0.79 • n=32 Participants • missing data
|
2.8 hours
STANDARD_DEVIATION 0.76 • n=64 Participants • missing data
|
|
ICU (hours) intensive care unit
|
21.5 hours)
n=33 Participants • missing data
|
11 hours)
n=32 Participants • missing data
|
20 hours)
n=65 Participants • missing data
|
PRIMARY outcome
Timeframe: within the 90 days after surgerypostsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Outcome measures
| Measure |
Group B
n=34 Participants
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 Participants
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Postsurgical Morbidity on Both Arms of the Study
postsurgical morbidity
|
10 Participants
|
8 Participants
|
|
Postsurgical Morbidity on Both Arms of the Study
moderate-severe postsurgical morbidity
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: during the 6 months having the intragastric balloon and 90 days after surgeryPopulation: Group B did not receive an intra-gastric balloon, and was thus not evaluated for balloon related complications.
total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of "The accordion severity grading system ".
Outcome measures
| Measure |
Group B
n=34 Participants
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 Participants
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Total Postsurgical Morbidity
intragastric balloon morbidity (complications)
|
—
|
8 Participants
|
|
Total Postsurgical Morbidity
severe intragastric balloon morbidity
|
—
|
2 Participants
|
|
Total Postsurgical Morbidity
total postsurgical morbidity
|
10 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: the period of the study started when patients were randomizated and finished 90 days after surgeryall in all hospital stay
Outcome measures
| Measure |
Group B
n=34 Participants
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 Participants
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Hospital Stay,
|
10.3 days
Standard Deviation 15.3
|
7 days
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: during the initial laparoscopic surgerynumber of patients with surgical conversion from laparoscopic to open surgery
Outcome measures
| Measure |
Group B
n=34 Participants
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 Participants
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Rate of Surgical Conversion to Open Surgery
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: during all the period of the study ending within 90 days after surgeryPercentage of Re-operations during all the period of the study ending within 90 days after surgery
Outcome measures
| Measure |
Group B
n=34 Participants
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 Participants
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Percentage of Re-operations
|
11.8 percentage of participants
|
6.3 percentage of participants
|
Adverse Events
Group B
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
IGB Group A
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group B
n=34 participants at risk
34 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 participants at risk
32 patients included have a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Renal and urinary disorders
acute renal failure
|
5.9%
2/34 • Number of events 8 • from randomization six months before surgery to 90 days after surgey
|
3.1%
1/32 • Number of events 1 • from randomization six months before surgery to 90 days after surgey
|
Other adverse events
| Measure |
Group B
n=34 participants at risk
34 patients control group : patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
|
IGB Group A
n=32 participants at risk
32 patients included have a preoperative intragastric balloon during a period of 6 months before operation
preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
|
|---|---|---|
|
Infections and infestations
surgical wound infection
|
23.5%
8/34 • Number of events 15 • from randomization six months before surgery to 90 days after surgey
|
21.9%
7/32 • Number of events 9 • from randomization six months before surgery to 90 days after surgey
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place