Bariatric Surgery CandidateNCT04834323
Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy;
A study testing distal mesogastric fixation after sleeve gastrectomy in people with Bariatric Surgery Candidate, run by Zagazig University at 1 site in Egypt.
Trial summary
This study included patients who were admitted to investigator's center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- distal mesogastric fixation after sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Jan 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who had no contraindication for laparoscopic surgery.
- patients with good general condition with American society of anesthesiology (ASA) I \& II.
- patients with body mass index above 35 were included.
Who cannot join
- 1 - patients who had bad general condition (ASA ≥3). 2- patients with gastro esophageal reflux or hiatal hernia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy; A Randomized Control Trial
This study included patients who were admitted to investigator's center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
Read the detailed description
Laparoscopic sleeve gastrectomy is one of weight loss operations and widely performed all over the world . although its widely performed ,it has serious complications like leakage and bleeding . The proposed etiology behind leakage after laparoscopic sleeve gastrectomy may be the axial rotation of the stomach owing to loss of abdominal ligament fixation along the greater curvature of the stomach . The mechanism of increased intra-gastric pressure due to axial gastric rotation may put a lot of stress on the staple lines with increased incidence of leakage. Other complications may occur such as vomiting, food intolerance or persistent reflux.
Objectives:
To assess the effect of distal mesogastric fixation after laparoscopic sleeve gastrectomy to minimize gastric axial rotation and subsequent leakage and other related complications.
Patients and methods:
investigators included all patients who were subjected to laparoscopic sleeve gastrectomy at investigators' center between December 2019 to December 2020. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants.
Sample size The sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , the percent of patients without leak after LSG was 66.6% while after new technique expected to be 95% , odd ratio 9.5% and ratio between two group 1:1; so the calculated sample size was 72 patients , taking into consideration 20% drop outs so the final sample size will be 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
Patients who had no contraindication for laparoscopic surgery (such as patients with no history of abdominal operations), good general condition with American society of anesthesiology (ASA) I \& II, and patients with body mass index above 35 were included. investigators excluded patients who had bad general condition (ASA ≥3), patients with gastro esophageal reflux or hiatal hernia.
Perioperative measures:
In this prospective randomized control trials , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile ) , radiological investigations ( chest x- ray , CT with oral and I.V contrast ) \& patients were subjected to upper GI endoscopy.
Surgical techniques :
investigators performed traditional laparoscopic sleeve gastrectomy then investigators fixed the greater omentum \& mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum \& mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation as in figures .
Follow up after surgery and discharge from the hospital:
investigators examined the patients clinically, made routine laboratory investigations , made follow up CT with oral and I.V contrast in first week after the operation if suspected leakage \& patients were subjected to upper GI endoscopy in first week after the operation if suspected leakage. The patients were followed up for one week, two weeks and one month, 6months post operatively.
Statistical analysis:
The collected data were analyzed by computer using Statistical Package of Social Services version 22 (SPSS), Data were represented in tables and graphs, Continuous Quantitative variables e.g. age were expressed as the mean ± SD \& (range), and categorical qualitative variables were expressed as absolute frequencies (number) \& relative frequencies (percentage).
Suitable statistical tests of significance were used after checked for normality. Categorical data were cross tabulated and analyzed by the Chi-square test or Fisher's Exact Test; Continuous data were evaluated by student t- test. The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).
- Conditions
- Bariatric Surgery Candidate
- Being tested
- distal mesogastric fixation after sleeve gastrectomy
- Keywords
- Laparoscopic Sleeve Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal mesogastric fixation after sleeve gastrectomyProcedure or surgery
Investigators performed traditional laparoscopic sleeve gastrectomy then we fixed the greater omentum \& mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum \& mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation
| Study group | Role | What they receive |
|---|---|---|
| group (1) | Active comparator | included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy Receives: Procedure: distal mesogastric fixation after sleeve gastrectomy |
| group (2) | No intervention | included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of Axial gastric rotation.
Incidence of Axial gastric rotation after the operation
Measured: Within one week after the operation
Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of gastric leakage .
Percentage of patients developed gastric leakage after the operation
Measured: Within one week after the operation
Secondary outcomes (1)
Quality of life after distal mesogasric fixation after laparoscopic sleeve gastrectomy
Incidence of side effects of distal mesogasric fixation after laparoscopic sleeve gastrectomy e.g bleeding , vomiting.
Measured: Within one month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Dec 2019
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study included patients who were admitted to our center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Said Mohamed Said Abdou Negm, Zagazig University
- Investigators
- Said Mohamed Negm, MD, Principal investigator, ZAGAZIG UNIVERSITY HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834323
- Sponsor's protocol ID
- Said Negm
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angrisani L, Santonicola A, Iovino P, Vitiello A, Higa K, Himpens J, Buchwald H, Scopinaro N. IFSO Worldwide Survey 2016: Primary, Endoluminal, and Revisional Procedures. Obes Surg. 2018 Dec;28(12):3783-3794. doi: 10.1007/s11695-018-3450-2.
PubMed 30121858Benedix F, Poranzke O, Adolf D, Wolff S, Lippert H, Arend J, Manger T, Stroh C; Obesity Surgery Working Group Competence Network Obesity. Staple Line Leak After Primary Sleeve Gastrectomy-Risk Factors and Mid-term Results: Do Patients Still Benefit from the Weight Loss Procedure? Obes Surg. 2017 Jul;27(7):1780-1788. doi: 10.1007/s11695-017-2543-7.
PubMed 28078641Abou Rached A, Basile M, El Masri H. Gastric leaks post sleeve gastrectomy: review of its prevention and management. World J Gastroenterol. 2014 Oct 14;20(38):13904-10. doi: 10.3748/wjg.v20.i38.13904.
PubMed 25320526Gagner M. Decreased incidence of leaks after sleeve gastrectomy and improved treatments. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):611-2. doi: 10.1016/j.soard.2014.04.002. Epub 2014 Apr 14. No abstract available.
PubMed 25224165Nimeri A, Ibrahim M, Maasher A, Al Hadad M. Management Algorithm for Leaks Following Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jan;26(1):21-5. doi: 10.1007/s11695-015-1751-2.
PubMed 26071239Alizadeh RF, Li S, Inaba C, Penalosa P, Hinojosa MW, Smith BR, Stamos MJ, Nguyen NT. Risk Factors for Gastrointestinal Leak after Bariatric Surgery: MBASQIP Analysis. J Am Coll Surg. 2018 Jul;227(1):135-141. doi: 10.1016/j.jamcollsurg.2018.03.030. Epub 2018 Mar 30.
PubMed 29605723Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013 Feb;257(2):231-7. doi: 10.1097/SLA.0b013e31826cc714.
PubMed 23023201Al-Sabah S, Ladouceur M, Christou N. Anastomotic leaks after bariatric surgery: it is the host response that matters. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):152-7; discussion 157-8. doi: 10.1016/j.soard.2007.12.010. Epub 2008 Mar 4.
PubMed 18294924Negm S, Amin M, Shafiq A, Atef B, Yassin M, Farag A. The short-term outcome of distal mesogastric fixation after laparoscopic sleeve gastrectomy: a randomized controlled trial. Surg Today. 2022 Mar;52(3):510-513. doi: 10.1007/s00595-022-02459-x. Epub 2022 Jan 31.
PubMed 35099602
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy; A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04834323
- Acronym / sponsor ID
- Said Negm
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 8 Apr 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.
This study included patients who were admitted to investigator's center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
Detailed description
Laparoscopic sleeve gastrectomy is one of weight loss operations and widely performed all over the world . although its widely performed ,it has serious complications like leakage and bleeding . The proposed etiology behind leakage after laparoscopic sleeve gastrectomy may be the axial rotation of the stomach owing to loss of abdominal ligament fixation along the greater curvature of the stomach . The mechanism of increased intra-gastric pressure due to axial gastric rotation may put a lot of stress on the staple lines with increased incidence of leakage. Other complications may occur such as vomiting, food intolerance or persistent reflux.
Objectives:
To assess the effect of distal mesogastric fixation after laparoscopic sleeve gastrectomy to minimize gastric axial rotation and subsequent leakage and other related complications.
Patients and methods:
investigators included all patients who were subjected to laparoscopic sleeve gastrectomy at investigators' center between December 2019 to December 2020. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants.
Sample size The sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , the percent of patients without leak after LSG was 66.6% while after new technique expected to be 95% , odd ratio 9.5% and ratio between two group 1:1; so the calculated sample size was 72 patients , taking into consideration 20% drop outs so the final sample size will be 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
Patients who had no contraindication for laparoscopic surgery (such as patients with no history of abdominal operations), good general condition with American society of anesthesiology (ASA) I \& II, and patients with body mass index above 35 were included. investigators excluded patients who had bad general condition (ASA ≥3), patients with gastro esophageal reflux or hiatal hernia.
Perioperative measures:
In this prospective randomized control trials , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile ) , radiological investigations ( chest x- ray , CT with oral and I.V contrast ) \& patients were subjected to upper GI endoscopy.
Surgical techniques :
investigators performed traditional laparoscopic sleeve gastrectomy then investigators fixed the greater omentum \& mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum \& mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation as in figures .
Follow up after surgery and discharge from the hospital:
investigators examined the patients clinically, made routine laboratory investigations , made follow up CT with oral and I.V contrast in first week after the operation if suspected leakage \& patients were subjected to upper GI endoscopy in first week after the operation if suspected leakage. The patients were followed up for one week, two weeks and one month, 6months post operatively.
Statistical analysis:
The collected data were analyzed by computer using Statistical Package of Social Services version 22 (SPSS), Data were represented in tables and graphs, Continuous Quantitative variables e.g. age were expressed as the mean ± SD \& (range), and categorical qualitative variables were expressed as absolute frequencies (number) \& relative frequencies (percentage).
Suitable statistical tests of significance were used after checked for normality. Categorical data were cross tabulated and analyzed by the Chi-square test or Fisher's Exact Test; Continuous data were evaluated by student t- test. The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study included patients who were admitted to our center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
| Arm | Type | Receives |
|---|---|---|
| group (1) | Active comparator | Procedure: distal mesogastric fixation after sleeve gastrectomyincluded 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy |
| group (2) | No intervention | –included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who had no contraindication for laparoscopic surgery.
- patients with good general condition with American society of anesthesiology (ASA) I \& II.
- patients with body mass index above 35 were included.
Key exclusion criteria (1 listed)
- 1 - patients who had bad general condition (ASA ≥3). 2- patients with gastro esophageal reflux or hiatal hernia.
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 |
|---|---|---|
| distal mesogastric fixation after sleeve gastrectomyInvestigators performed traditional laparoscopic sleeve gastrectomy then we fixed the greater omentum \& mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum \& mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation | Procedure or surgery | group (1) |
Primary outcome
Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of Axial gastric rotation.
Time frame: Within one week after the operation
Incidence of Axial gastric rotation after the operation
Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of gastric leakage .
Time frame: Within one week after the operation
Percentage of patients developed gastric leakage after the operation
1 secondary outcome
Quality of life after distal mesogasric fixation after laparoscopic sleeve gastrectomy
Time frame: Within one month after the operation
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 8 Apr 2021.
- Background: PubMed 30121858Angrisani L, Santonicola A, Iovino P, Vitiello A, Higa K, Himpens J, Buchwald H, Scopinaro N. IFSO Worldwide Survey 2016: Primary, Endoluminal, and Revisional Procedures. Obes Surg. 2018 Dec;28(12):3783-3794. doi: 10.1007/s11695-018-3450-2.
- Background: PubMed 28078641Benedix F, Poranzke O, Adolf D, Wolff S, Lippert H, Arend J, Manger T, Stroh C; Obesity Surgery Working Group Competence Network Obesity. Staple Line Leak After Primary Sleeve Gastrectomy-Risk Factors and Mid-term Results: Do Patients Still Benefit from the Weight Loss Procedure? Obes Surg. 2017 Jul;27(7):1780-1788. doi: 10.1007/s11695-017-2543-7.
- Background: PubMed 25320526Abou Rached A, Basile M, El Masri H. Gastric leaks post sleeve gastrectomy: review of its prevention and management. World J Gastroenterol. 2014 Oct 14;20(38):13904-10. doi: 10.3748/wjg.v20.i38.13904.
- Background: PubMed 25224165Gagner M. Decreased incidence of leaks after sleeve gastrectomy and improved treatments. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):611-2. doi: 10.1016/j.soard.2014.04.002. Epub 2014 Apr 14. No abstract available.
- Background: PubMed 26071239Nimeri A, Ibrahim M, Maasher A, Al Hadad M. Management Algorithm for Leaks Following Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jan;26(1):21-5. doi: 10.1007/s11695-015-1751-2.
- Background: PubMed 29605723Alizadeh RF, Li S, Inaba C, Penalosa P, Hinojosa MW, Smith BR, Stamos MJ, Nguyen NT. Risk Factors for Gastrointestinal Leak after Bariatric Surgery: MBASQIP Analysis. J Am Coll Surg. 2018 Jul;227(1):135-141. doi: 10.1016/j.jamcollsurg.2018.03.030. Epub 2018 Mar 30.
- Background: PubMed 23023201Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013 Feb;257(2):231-7. doi: 10.1097/SLA.0b013e31826cc714.
- Background: PubMed 18294924Al-Sabah S, Ladouceur M, Christou N. Anastomotic leaks after bariatric surgery: it is the host response that matters. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):152-7; discussion 157-8. doi: 10.1016/j.soard.2007.12.010. Epub 2008 Mar 4.
- Derived from this study: PubMed 35099602Negm S, Amin M, Shafiq A, Atef B, Yassin M, Farag A. The short-term outcome of distal mesogastric fixation after laparoscopic sleeve gastrectomy: a randomized controlled trial. Surg Today. 2022 Mar;52(3):510-513. doi: 10.1007/s00595-022-02459-x. Epub 2022 Jan 31.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery Candidate
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
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.
Said Mohamed Negm, MD principal investigator
ZAGAZIG UNIVERSITY HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distal mesogastric fixation after sleeve gastrectomy in people with Bariatric Surgery Candidate, run by Zagazig University at 1 site in Egypt.
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 1 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 8 Apr 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 Egypt. 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?
Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of Axial gastric rotation. (time frame: Within one week after the operation). The study lists 2 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 NCT04834323, which also lists 9 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 8 Apr 2021.