Upper GIT SurgeryNCT03417089
Suspension of Falciform Ligament During Mini Gastric Bypass
A study testing Falciform ligament suspension and no suspension in people with Upper GIT Surgery, run by Minia University at 1 site in Egypt.
Trial summary
The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Upper GIT Surgery
- What is being tested?
- Falciform ligament suspension and no suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 20 Jul 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbidly obese patient with BMI more than 40 with or without co-morbidity
- Morbidly obese patient with BMI more than 35 with co-morbidity
Who cannot join
- Unfit patients for laparoscopic sleeve gastrectomy
- Patients refuse to share in the study
- Patients that already on PPI due to any indications
- Revisional surgery for obesity
- Previous upper abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension
Read the detailed description
The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension
- Conditions
- Upper GIT Surgery
- Being tested
- Falciform ligament suspension, no suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falciform ligament suspensionProcedure or surgery
routine of falciform ligament suspension during Mini gastric bypass
no suspensionProcedure or surgery
working without of falciform ligament suspension during Mini gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| falciform ligament suspension | Experimental | routine suspension of falciform ligament during mini gastric bypass, Receives: Procedure: Falciform ligament suspension |
| No suspension | Active comparator | working without suspension of the falciform ligament Receives: Procedure: no suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difficulty of working during mini gastric bypass
difficulty of working during mini gastric bypass assessed by many parameters like number of clashing of instruments per one operations and operative time
Measured: 5 hours
Secondary outcomes (1)
operative time
duration of the operation from skin to skin
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Feb 2018
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GIT SurgeryStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
- Investigators
- Alaa M Sewefy, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417089
- Sponsor's protocol ID
- fac.med.052
- Status last verified
- Mar 2020
- First submitted
- 18 Jan 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspension of Falciform Ligament During Mini Gastric Bypass
- ClinicalTrials.gov ID
- NCT03417089
- Acronym / sponsor ID
- fac.med.052
- Conditions
- Upper GIT Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 31 Jan 2018 (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.
The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension
Detailed description
The falciform ligament is hanging down in the upper abdomen and usually impede the work during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study is to evaluate the impact of routine suspension of falciform ligament during mini gastric bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of patient in the fist group the investigators will routinely suspend the falciform ligament and the other group the investigators will working without suspension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| falciform ligament suspension | Experimental | Procedure: Falciform ligament suspensionroutine suspension of falciform ligament during mini gastric bypass, |
| No suspension | Active comparator | Procedure: no suspensionworking without suspension of the falciform ligament |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Morbidly obese patient with BMI more than 40 with or without co-morbidity
- Morbidly obese patient with BMI more than 35 with co-morbidity
Key exclusion criteria (5 listed)
- Unfit patients for laparoscopic sleeve gastrectomy
- Patients refuse to share in the study
- Patients that already on PPI due to any indications
- Revisional surgery for obesity
- Previous upper abdominal surgery
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 |
|---|---|---|
| Falciform ligament suspensionroutine of falciform ligament suspension during Mini gastric bypass | Procedure or surgery | falciform ligament suspension |
| no suspensionworking without of falciform ligament suspension during Mini gastric bypass | Procedure or surgery | No suspension |
Primary outcome
the difficulty of working during mini gastric bypass
Time frame: 5 hours
difficulty of working during mini gastric bypass assessed by many parameters like number of clashing of instruments per one operations and operative time
1 secondary outcome
operative time
Time frame: 6 hours
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 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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.
Alaa M Sewefy, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falciform ligament suspension and no suspension in people with Upper GIT Surgery, run by Minia 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 2 inclusion and 5 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 17 Mar 2020. 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?
the difficulty of working during mini gastric bypass (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2020.