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Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity

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ClinicalTrials.gov Identifier: NCT01998243
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
luis ramon rábago torre, Hospital Severo Ochoa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Morbid Obesity
Interventions Device: Intragastric Balloon (IGB), group A
Other: diet, control group B
Enrollment 81
Recruitment Details 151 patients were eligibles for the study and were evaluated at the endocrinologist office
Pre-assignment Details 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
Arm/Group Title Group B IGB-BIB® Group A
Hide Arm/Group Description 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

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

Period Title: Overall Study
Started 42 39
Completed 34 32
Not Completed 8 7
Reason Not Completed
Pregnancy             0             1
Protocol Violation             5             2
Withdrawal by Subject             3             4
Arm/Group Title Group B Intragastrc Balloon (IGB) Group A Total
Hide Arm/Group Description 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

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 of all reporting groups
Overall Number of Baseline Participants 34 32 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years OF AGE
Number Analyzed 34 participants 32 participants 66 participants
42.6  (9.2) 43  (10.2) 42.8  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
Female
24
  70.6%
21
  65.6%
45
  68.2%
Male
10
  29.4%
11
  34.4%
21
  31.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
Hispanic or Latino
34
 100.0%
32
 100.0%
66
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Spain Number Analyzed 34 participants 32 participants 66 participants
34
 100.0%
32
 100.0%
66
 100.0%
Americam Society of Anestesiologist Physical Status Classification System (ASA) ; ASA score III;   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
11 12 23
[1]
Measure Description: Physical Status Classification System (ASA) ASA classification scores patients ranging from I - V ; ASA I A normal healthy patient Healthy, ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation E , ASA VI A declared brain-dead patient whose organs are being removed for donor purposes .WE MEASURE THE NUMBER of participants IN EACH GROUP classified as ASA III
Starting weight (kg)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 34 participants 32 participants 66 participants
125  (18.5) 129.2  (19.4) 127.1  (18.9)
[1]
Measure Description: the starting weight is expressed in Kg
Starting body mass index (starting BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  "kg/m^2"
Number Analyzed 34 participants 32 participants 66 participants
46  (4.9) 46.4  (6.9) 46.2  (5.7)
[1]
Measure Description: Starting body mass index (starting BMI) is expressed in kg/m^2
Starting body mass index (starting BMI) > 50 ("kg/m^2")   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
8
  23.5%
7
  21.9%
15
  22.7%
[1]
Measure Description: number of patientes with a Starting body mass index (starting BMI) > 50 "kg/m^2"
Total weight loss (TWL)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 34 participants 32 participants 66 participants
3
(1 to 6.5)
16
(8.2 to 22.7)
7
(3 to 17.7)
[1]
Measure Description: Total weight loss (TWL) is expressed in Kg
Weight before surgery (Kg)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 34 participants 32 participants 66 participants
121.3  (20.5) 112.8  (16.4) 117.2  (19.0)
[1]
Measure Description: Weight before surgery is expressed in KG
BMI before surgery("kg/m^2")  
Mean (Standard Deviation)
Unit of measure:  "kg/m^2"
Number Analyzed 34 participants 32 participants 66 participants
44.3  (5.5) 40  (6.2) 42.2  (5.9)
Excess weight loss (EWL) before surgery   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Percentage of EWL
Number Analyzed 32 participants 32 participants 64 participants
4.54
(1.4 to 10.07)
27.14
(12.2 to 35.2)
11.1
(3.4 to 28.9)
[1]
Measure Description: Excess weight loss (EWL) before surgery is expressed as a percentage %
[2]
Measure Analysis Population Description: missing data
Excess Body Mass Index Loss (EBMIL) before surgery (excess BMI loss)  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of EBMI loss
Number Analyzed 34 participants 32 participants 66 participants
1
(0 to 2)
6.04
(3.9 to 7.9)
3
(1 to 6.5)
Surgery (sleeve resection (LSG)or gastric bypass (LGBP)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
LSG
11
  32.4%
9
  28.1%
20
  30.3%
LGBP
23
  67.6%
23
  71.9%
46
  69.7%
total body weight loss (TBWL) > 10%   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
4
  12.5%
18
  56.3%
22
  34.4%
[1]
Measure Analysis Population Description: missing data
Percentage of Failure of Intragastric Balloon   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 32 participants 32 participants
11
  34.4%
11
  34.4%
[1]
Measure Description:

It was considered that intragastric balloon failed when a total weight loss = or > than 10% of the starting weight has NOT been achieved.

The total number of patients with IGB balloon was 41 in this essay, but 9 were excluded post randomization of the final analysis because they were not finally operated.

The percentage of IGB balloon failure was calculated for all the patients had intragastric balloon

[2]
Measure Analysis Population Description: this variable is not applicable to group B
Operation time (hours)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 32 participants 32 participants 64 participants
2.8  (0.73) 2.8  (0.79) 2.8  (0.76)
[1]
Measure Description: Operation time is expressed in hours
[2]
Measure Analysis Population Description: missing data
ICU (hours) intensive care unit   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Hours)
Number Analyzed 33 participants 32 participants 65 participants
21.5
(7.2 to 23)
11
(8 to 24)
20
(8 to 23)
[1]
Measure Description: time spent in the intensive care unit is expressed in ICU (hours)
[2]
Measure Analysis Population Description: missing data
1.Primary Outcome
Title Postsurgical Morbidity on Both Arms of the Study
Hide Description postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Time Frame within the 90 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B IGB Group A
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 34 32
Measure Type: Count of Participants
Unit of Measure: Participants
postsurgical morbidity
10
  29.4%
8
  25.0%
moderate-severe postsurgical morbidity
8
  23.5%
4
  12.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B, IGB Group A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.689
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.53 to 2.60
Estimation Comments risk ratio (RR)
2.Primary Outcome
Title Total Postsurgical Morbidity
Hide Description 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 ".
Time Frame during the 6 months having the intragastric balloon and 90 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Group B did not receive an intra-gastric balloon, and was thus not evaluated for balloon related complications.
Arm/Group Title Group B IGB Group A
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 34 32
Measure Type: Count of Participants
Unit of Measure: Participants
intragastric balloon morbidity (complications) Number Analyzed 0 participants 32 participants
8
  25.0%
severe intragastric balloon morbidity Number Analyzed 0 participants 32 participants
2
   6.3%
total postsurgical morbidity Number Analyzed 34 participants 32 participants
10
  29.4%
15
  46.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B, IGB Group A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
0.84 to 3.01
Estimation Comments all in all balloon and postsurgical morbidity in group A vs. group B.
3.Secondary Outcome
Title Hospital Stay,
Hide Description all in all hospital stay
Time Frame the period of the study started when patients were randomizated and finished 90 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B IGB Group A
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 34 32
Mean (Standard Deviation)
Unit of Measure: days
10.3  (15.3) 7  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B, IGB Group A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.937
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Rate of Surgical Conversion to Open Surgery
Hide Description number of patients with surgical conversion from laparoscopic to open surgery
Time Frame during the initial laparoscopic surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B IGB Group A
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 34 32
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.9%
1
   3.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B, IGB Group A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Re-operations
Hide Description Percentage of Re-operations during all the period of the study ending within 90 days after surgery
Time Frame during all the period of the study ending within 90 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group B IGB Group A
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: percentage of participants
11.8 6.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B, IGB Group A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame from randomization six months before surgery to 90 days after surgey
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group B IGB Group A
Hide Arm/Group Description 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

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

All-Cause Mortality
Group B IGB Group A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/32 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group B IGB Group A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/34 (5.88%)      1/32 (3.13%)    
Renal and urinary disorders     
acute renal failure  [1]  2/34 (5.88%)  8 1/32 (3.13%)  1
Indicates events were collected by systematic assessment
[1]
peritonitis, sepsis, suture dehiscence, respiratory failure, eventration intraperitoneal postoperative bleeding
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group B IGB Group A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/34 (23.53%)      7/32 (21.88%)    
Infections and infestations     
surgical wound infection  [1]  8/34 (23.53%)  15 7/32 (21.88%)  9
Indicates events were collected by systematic assessment
[1]
mild surgical wound infection ,mild respiratory failure ,eventration, intra abdominal abscess, urinary tract infection, bleeding, haematoma,pneumonia
we could not reach the number of scheduled patients in the study, due to the number of postrandomization excluded patients; the number of superobese is too short in order to get conclusion in this small group of patients
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Luis Ramon Rabago Torre
Organization: Hospital severo ochoa
Phone: 34914818000 ext 8326
EMail: lrabagot@gmail.com
Layout table for additonal information
Responsible Party: luis ramon rábago torre, Hospital Severo Ochoa
ClinicalTrials.gov Identifier: NCT01998243     History of Changes
Other Study ID Numbers: fis PI070682
FIS PI070682 ( Other Grant/Funding Number: SPANISH NATIONAL HEALTH SYSTEM, LAIN ENTRALGO AGENCY )
First Submitted: November 19, 2013
First Posted: November 28, 2013
Results First Submitted: April 13, 2017
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019