Obesity, MorbidNCT03231423
Effect of Drainage on Laparoscopic Gastric Bypass Surgery
A study testing Drainage in people with Obesity, Morbid, run by Inonu University.
Trial summary
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2016to 22 Jun 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Morbid obese patients
Who cannot join
- Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery) were excluded
About this study
Official title: Effect of Drain Usage on Patient Comfort on Laparoscopic Gastric Bypass Surgery
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.
Read the detailed description
Question the necessity of routine use of drain in RYGB surgeon
- Conditions
- Obesity, Morbid
- Being tested
- Drainage
- Keywords
- Obesity, VAS, Pain, Laparoscopy, Bypass
- Medical subject headings
- Obesity, Morbid, Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainageOther
Using drain after operation
| Study group | Role | What they receive |
|---|---|---|
| DRAIN PLACEMENT | Experimental | Effects of drainage Receives: Other: Drainage |
| DRAIN NOT PLACED | No intervention | Effects of not using drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Item Pain Intensity measyre (P3)
self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start9 Dec 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Inonu 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Gündoğan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231423
- Sponsor's protocol ID
- 2016/181
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Drain Usage on Patient Comfort on Laparoscopic Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT03231423
- Acronym / sponsor ID
- 2016/181
- Conditions
- Obesity, Morbid
- Keywords
- Obesity, VAS, Pain, Laparoscopy, Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 27 Jul 2017 (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.
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.
Detailed description
Question the necessity of routine use of drain in RYGB surgeon
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRAIN PLACEMENT | Experimental | Other: DrainageEffects of drainage |
| DRAIN NOT PLACED | No intervention | –Effects of not using drain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Morbid obese patients
Key exclusion criteria (1 listed)
- Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery) were excluded
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 |
|---|---|---|
| DrainageUsing drain after operation | Other | DRAIN PLACEMENT |
Primary outcome
3-Item Pain Intensity measyre (P3)
Time frame: 8 months
self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)
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 27 Jul 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Drainage in people with Obesity, Morbid, run by Inonu University.
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 1 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
3-Item Pain Intensity measyre (P3) (time frame: 8 months). 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 27 Jul 2017.