Reflux Disease, Gastro-EsophagealNCT07148492
Antireflux Suture In One Anastomsis Gastric Bypass
A study testing Antireflux suture and No Antireflux suture in people with Reflux Disease, Gastro-Esophageal and Vomiting, Postoperative, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
To prevent refulx symptoms in a type of bariatric surgery, a suture is taken.there is no enough evidence in support of or against the suture. our study aims to compare the symptoms of patients in whom the suture is taken and in those in whom it is not. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Reflux Disease, Gastro-Esophageal, Vomiting, Postoperative
- What is being tested?
- Antireflux suture and No Antireflux suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing one anastomosis gastric bypass surgery
Who cannot join
- Non consenting individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Khyber teaching hospital
Peshawar, Khyberpukhtunkhwa, 25000
Saeed Sarwar, MBBS, +923420973863, saeedkmc2020@gmail.com
About this study
Official title: Antireflux Suture In Laparoscopic One Anastomsis Gastric Bypass Surgery, A Randomised Control Trial
To prevent refulx symptoms in a type of bariatric surgery, a suture is taken.there is no enough evidence in support of or against the suture. our study aims to compare the symptoms of patients in whom the suture is taken and in those in whom it is not.
- Being tested
- Antireflux suture, No Antireflux suture
- Medical subject headings
- Gastroesophageal Reflux, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antireflux sutureProcedure or surgery
Antireflux suture will be taken in this intervention group
No Antireflux sutureProcedure or surgery
Antireflux suture will not be taken in this intervention group
| Study group | Role | What they receive |
|---|---|---|
| Antireflux suture group | Experimental | This group consist of patients in whom antireflux suture is taken Receives: Procedure: Antireflux suture |
| No Antireflux suture | Experimental | This group consist of patients in whom no antireflux suture is taken Receives: Procedure: No Antireflux suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux disease
The incidence of gastroesophageal reflux will be measured after surgery
Measured: 3 months and 6 months postoperatively
Secondary outcomes (1)
Postoperative vomiting
Incidence of postoperative vomiting will be measured
Measured: At 3 months and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux Disease, Gastro-EsophagealStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Saeed Sarwar, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148492
- Sponsor's protocol ID
- 528/DME/KMC
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients privacy may be breached
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antireflux Suture In Laparoscopic One Anastomsis Gastric Bypass Surgery, A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07148492
- Acronym / sponsor ID
- 528/DME/KMC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Aug 2025 (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.
To prevent refulx symptoms in a type of bariatric surgery, a suture is taken.there is no enough evidence in support of or against the suture. our study aims to compare the symptoms of patients in whom the suture is taken and in those in whom it is not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antireflux suture group | Experimental | Procedure: Antireflux sutureThis group consist of patients in whom antireflux suture is taken |
| No Antireflux suture | Experimental | Procedure: No Antireflux sutureThis group consist of patients in whom no antireflux suture is taken |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing one anastomosis gastric bypass surgery
Key exclusion criteria (1 listed)
- Non consenting individuals
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 |
|---|---|---|
| Antireflux sutureAntireflux suture will be taken in this intervention group | Procedure or surgery | Antireflux suture group |
| No Antireflux sutureAntireflux suture will not be taken in this intervention group | Procedure or surgery | No Antireflux suture |
Primary outcome
Reflux disease
Time frame: 3 months and 6 months postoperatively
The incidence of gastroesophageal reflux will be measured after surgery
1 secondary outcome
Postoperative vomiting
Time frame: At 3 months and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No. Patients privacy may be breached
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antireflux suture and No Antireflux suture in people with Reflux Disease, Gastro-Esophageal and Vomiting, Postoperative, run by Khyber Teaching Hospital 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 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saeed Sarwar, MBBS (+923420973863, saeedkmc2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux disease (time frame: 3 months and 6 months postoperatively). 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 29 Aug 2025.