Bariatric SurgeryBariatricNCT04779723
30-Days Post-Operative Complications in Bariatric Surgery
A study testing Comparison of two Techniques of bariatric surgery in people with Bariatric Surgery, run by Multan Medical And Dental College at 1 site in Pakistan.
Trial summary
comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Comparison of two Techniques of bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2018to 12 Oct 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of age 18 to 65 years
- body mass index (BMI) >35 kg/m2 (Morbidly obese)
- Patients with failed conservative treatment of weight control
Who cannot join
- Severe indicative gastroesophageal reflux disease (GERD)
- Conversion of another bariatric procedure
- Large hiatal hernia
- Patients with inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Multan Medical and Dental College
Multan, Punjab Province, 57000
About this study
Official title: Comparison of Laparoscopic Sleeve Gastrectomy (LSG) With Laparoscopic Gastric Bypass (LRYGB) in Bariatric Surgery; 30-Days Post-Operative Complications in Bariatric Surgery
comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)
Read the detailed description
Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan . Half of the people in this world consider themselves overweight or obese. Obesity is challenging to control by medical therapy and drug treatment. The most effective way to treat obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold standard" bariatric surgical procedure. Recently there is much attention gained by laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative study to compare the early post-op complications of LSG with LRYGB technique in patients undergoing bariatric surgery.
- Conditions
- Bariatric Surgery
- Being tested
- Comparison of two Techniques of bariatric surgery
- Keywords
- Bariatric surgery, Laparoscopic Roux-en-Y gastric bypass, Laparoscopic sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two Techniques of bariatric surgeryProcedure or surgery
We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB
| Study group | Role | What they receive |
|---|---|---|
| LRYGB Procedure | Active comparator | LRYGB technique was performed by placing 4 to 6 trocars, a 150 cm ante-colic Roux-limb gastric pouch (30 to 50 ml) was created with linear stapled or circular stapled gastro-jejunostomy, a 50-cm long biliopancreatic limb was chosen. A passive drainage was kept near to the gastro-jejunostomy. Receives: Procedure: Comparison of two Techniques of bariatric surgery |
| LSG Procedure | Active comparator | 35 Fr bougie was used for the calibration of a gastric tube. 3 to 6 cm of longitudinal incision of the stomach was done at pylorus to the angle of His. Using of absorbable suture, the staple line was sewn. Receives: Procedure: Comparison of two Techniques of bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Anastomotic Leakage in Each Study Arm
Patients were examined on postoperative 30 days for the presence of Anastomotic leakage
Measured: within the first 30 days after surgery
Frequency of Bleeding in Each Study Arm
Patients were examined postoperative for the presence of bleeding
Measured: 24 hours after surgery
Number of Infections in Each Study Arm
Patients were examined on postoperative 30 days for the presence of Wound infections
Measured: 30 days
Mortality in Each Study Arm
Patients were followed for 30 days and number of mortalities was noted on each arm
Measured: 30 days
Secondary outcomes (1)
Hospital Stay
Duration of hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start13 Jun 2018
- Primary completion12 Feb 2019
- Study completion12 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multan Medical And Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manzar Ali, Multan Medical And Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779723
- Sponsor's protocol ID
- MMDC-2018-023
- Acronym
- Bariatric
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallagher EJ, LeRoith D, Karnieli E. The metabolic syndrome--from insulin resistance to obesity and diabetes. Endocrinol Metab Clin North Am. 2008 Sep;37(3):559-79, vii. doi: 10.1016/j.ecl.2008.05.002.
PubMed 18775352Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
PubMed 30253139Siddiqui M, Hameed R, Nadeem M, Mohammad T, Simbak N, Latif A, et al. Obesity in Pakistan; current and future perceptions. J Curr Trends Biomed Eng Biosci. 2018;17:001-004
Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, Strong MB, Vinik R, Wanner NA, Hopkins PN, Gress RE, Walker JM, Cloward TV, Nuttall RT, Hammoud A, Greenwood JL, Crosby RD, McKinlay R, Simper SC, Smith SC, Hunt SC. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012 Sep 19;308(11):1122-31. doi: 10.1001/2012.jama.11164.
PubMed 22990271Suter M, Donadini A, Romy S, Demartines N, Giusti V. Laparoscopic Roux-en-Y gastric bypass: significant long-term weight loss, improvement of obesity-related comorbidities and quality of life. Ann Surg. 2011 Aug;254(2):267-73. doi: 10.1097/SLA.0b013e3182263b66.
PubMed 21772127Li K, Gao F, Xue H, Jiang Q, Wang Y, Shen Q, Tian Y, Yang Y. Comparative study on laparoscopic sleeve gastrectomy and laparoscopic gastric bypass for treatment of morbid obesity patients. Hepatogastroenterology. 2014 Mar-Apr;61(130):319-22.
PubMed 24901132Peterli R, Borbely Y, Kern B, Gass M, Peters T, Thurnheer M, Schultes B, Laederach K, Bueter M, Schiesser M. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Ann Surg. 2013 Nov;258(5):690-4; discussion 695. doi: 10.1097/SLA.0b013e3182a67426.
PubMed 23989054
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Sleeve Gastrectomy (LSG) With Laparoscopic Gastric Bypass (LRYGB) in Bariatric Surgery; 30-Days Post-Operative Complications in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04779723
- Acronym / sponsor ID
- Bariatric / MMDC-2018-023
- Conditions
- Bariatric Surgery
- Keywords
- Bariatric surgery, Laparoscopic Roux-en-Y gastric bypass, Laparoscopic sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Multan Medical And Dental CollegeUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Oct 2019 (actual)
- First posted
- 3 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.
comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)
Detailed description
Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan . Half of the people in this world consider themselves overweight or obese. Obesity is challenging to control by medical therapy and drug treatment. The most effective way to treat obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold standard" bariatric surgical procedure. Recently there is much attention gained by laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative study to compare the early post-op complications of LSG with LRYGB technique in patients undergoing bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRYGB Procedure | Active comparator | Procedure: Comparison of two Techniques of bariatric surgeryLRYGB technique was performed by placing 4 to 6 trocars, a 150 cm ante-colic Roux-limb gastric pouch (30 to 50 ml) was created with linear stapled or circular stapled gastro-jejunostomy, a 50-cm long biliopancreatic limb was chosen. A passive drainage was kept near to the gastro-jejunostomy. |
| LSG Procedure | Active comparator | Procedure: Comparison of two Techniques of bariatric surgery35 Fr bougie was used for the calibration of a gastric tube. 3 to 6 cm of longitudinal incision of the stomach was done at pylorus to the angle of His. Using of absorbable suture, the staple line was sewn. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients of age 18 to 65 years
- body mass index (BMI) >35 kg/m2 (Morbidly obese)
- Patients with failed conservative treatment of weight control
Key exclusion criteria (4 listed)
- Severe indicative gastroesophageal reflux disease (GERD)
- Conversion of another bariatric procedure
- Large hiatal hernia
- Patients with inflammatory bowel disease
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 |
|---|---|---|
| Comparison of two Techniques of bariatric surgeryWe compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB | Procedure or surgery | LRYGB Procedure, LSG Procedure |
Primary outcome
Frequency of Anastomotic Leakage in Each Study Arm
Time frame: within the first 30 days after surgery
Patients were examined on postoperative 30 days for the presence of Anastomotic leakage
Frequency of Bleeding in Each Study Arm
Time frame: 24 hours after surgery
Patients were examined postoperative for the presence of bleeding
Number of Infections in Each Study Arm
Time frame: 30 days
Patients were examined on postoperative 30 days for the presence of Wound infections
Mortality in Each Study Arm
Time frame: 30 days
Patients were followed for 30 days and number of mortalities was noted on each arm
1 secondary outcome
Hospital Stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 18775352Gallagher EJ, LeRoith D, Karnieli E. The metabolic syndrome--from insulin resistance to obesity and diabetes. Endocrinol Metab Clin North Am. 2008 Sep;37(3):559-79, vii. doi: 10.1016/j.ecl.2008.05.002.
- Background: PubMed 30253139Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
- BackgroundSiddiqui M, Hameed R, Nadeem M, Mohammad T, Simbak N, Latif A, et al. Obesity in Pakistan; current and future perceptions. J Curr Trends Biomed Eng Biosci. 2018;17:001-004
- Background: PubMed 22990271Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, Strong MB, Vinik R, Wanner NA, Hopkins PN, Gress RE, Walker JM, Cloward TV, Nuttall RT, Hammoud A, Greenwood JL, Crosby RD, McKinlay R, Simper SC, Smith SC, Hunt SC. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012 Sep 19;308(11):1122-31. doi: 10.1001/2012.jama.11164.
- Background: PubMed 21772127Suter M, Donadini A, Romy S, Demartines N, Giusti V. Laparoscopic Roux-en-Y gastric bypass: significant long-term weight loss, improvement of obesity-related comorbidities and quality of life. Ann Surg. 2011 Aug;254(2):267-73. doi: 10.1097/SLA.0b013e3182263b66.
- Background: PubMed 24901132Li K, Gao F, Xue H, Jiang Q, Wang Y, Shen Q, Tian Y, Yang Y. Comparative study on laparoscopic sleeve gastrectomy and laparoscopic gastric bypass for treatment of morbid obesity patients. Hepatogastroenterology. 2014 Mar-Apr;61(130):319-22.
- Background: PubMed 23989054Peterli R, Borbely Y, Kern B, Gass M, Peters T, Thurnheer M, Schultes B, Laederach K, Bueter M, Schiesser M. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Ann Surg. 2013 Nov;258(5):690-4; discussion 695. doi: 10.1097/SLA.0b013e3182a67426.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of two Techniques of bariatric surgery in people with Bariatric Surgery, run by Multan Medical And Dental College at 1 site in Pakistan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Anastomotic Leakage in Each Study Arm (time frame: within the first 30 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779723, which also lists 7 linked publications.
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 3 Mar 2021.