Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001406796
Ethics application status
Approved
Date submitted
4/10/2022
Date registered
2/11/2022
Date last updated
1/10/2023
Date data sharing statement initially provided
2/11/2022
Date results information initially provided
28/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastroesophageal Reflux and Sleep.
Scientific title
Evaluation of the effects of Nissen fundoplication on sleep quality in patients with gastroesophageal reflux.
Secondary ID [1] 308075 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux 327779 0
Nissen Fundoplication 328012 0
Condition category
Condition code
Oral and Gastrointestinal 324849 324849 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 325070 325070 0 0
Other surgery
Anaesthesiology 325071 325071 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Months
Description of intervention(s) / exposure
Gastroesophageal reflux (GER) is a common gastrointestinal system disease. It is characterized by heartburn and the escape of stomach contents into the esophagus. It may be associated with chronic cough, hoarseness, asthma, laryngitis, tooth and gum disorders, sleep disturbance. These symptoms can affect sleep quality. The basis of the surgical treatment of GER is laparoscopic fundoplication operations. The most common fundoplication is the laparoscopic Nissen fundoplication (NF). In our study, we aimed to investigate the effects of the operation on the sleep quality of our patients, whom we evaluated before and after the operation.In our study, the reflux symptoms and sleep quality of our patients
They will be asked to fill out a questionnaire for evaluation. Preoperative evaluation will be performed before the operation, during the preoperative anesthesia consultation or on the morning of the operation.Postoperative evaluation will be done face to face at the end of the first month. Patients for whom face-to-face evaluation cannot be performed will be asked to answer questions over the phone. This assessment will take approximately 10 minutes.
Intervention code [1] 324536 0
Diagnosis / Prognosis
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332667 0
Sleep quality assessed using the Pittsburg Sleep Quality Index
Timepoint [1] 332667 0
Preoperative evaluation will be performed during anesthesia consultation or on the morning of the operation day. Postoperative evaluation will be made 1 month after the surgery.
Secondary outcome [1] 414326 0
Reflux symptom severity assessed using the Reflux Symptom Index
Timepoint [1] 414326 0
Preoperative evaluation will be performed during anesthesia consultation or on the morning of the operation day. Postoperative evaluation will be made 1 month after the surgery.

Eligibility
Key inclusion criteria
Patients over the age of 18 with a diagnosis of GER, planned for Nissen fundoplication and undergoing surgery will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are illiterate in Turkish, those with psychiatric disorders and those who do not give consent will be excluded from the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical evaluation is planned with ANOVA analysis and Tukey Multiple comparison.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/09/2022
Date of last participant enrolment
Anticipated
31/10/2023
Actual
18/09/2023
Date of last data collection
Anticipated
18/10/2023
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 25024 0
Turkey
State/province [1] 25024 0
Karaman

Funding & Sponsors
Funding source category [1] 312330 0
Hospital
Name [1] 312330 0
Karaman training and research hospital
Country [1] 312330 0
Turkey
Primary sponsor type
Individual
Name
Sükrü Salih Toprak
Address
Karaman Egitim ve Arastirma Hastanesi Üniversite Mh., 1984. Sok. No:1, 70200 Merkez/Karaman.
Country
Turkey
Secondary sponsor category [1] 313905 0
Individual
Name [1] 313905 0
Hatice Toprak
Address [1] 313905 0
Karaman Egitim Ve Arastirma Hastanesi Üniversite Mh., 1984. Sok. No:1, 70200 Merkez/Karaman Merkez/Karaman.
Country [1] 313905 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311697 0
Karamanoglu Mehmetbey Üniversity Medicine Fakulty Etihics Committee
Ethics committee address [1] 311697 0
Gevher Hatun Mh. Karamanoglu Mehmetbey Ünv. Myo Yunus Emre Kampüsü Pk:70200 Karaman Merkez/karaman
Ethics committee country [1] 311697 0
Turkey
Date submitted for ethics approval [1] 311697 0
Approval date [1] 311697 0
31/08/2022
Ethics approval number [1] 311697 0

Summary
Brief summary
According to our hypothesis, reflux symptoms regressed with reflux surgery will contribute positively to sleep quality. Patients diagnosed with gastroesophageal reflux and undergoing nissen fundoplication operation will be evaluated with the Reflux Symptom Index and Pittsburg sleep quality questionnaire in the preoperative and postoperative 1st month.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122038 0
Dr Sükrü Salih Toprak
Address 122038 0
Karaman Egitim ve Arastirma Hastanesi Üniversite mah. 1984. sok. no:1 merkez/Karaman
Country 122038 0
Turkey
Phone 122038 0
+90338 226 3304
Fax 122038 0
Email 122038 0
[email protected]
Contact person for public queries
Name 122039 0
Dr Hatice Toprak
Address 122039 0
Karaman Egitim ve Arastirma Hastanesi Üniversite mah. 1984. sok. no:1 merkez/Karaman.
Country 122039 0
Turkey
Phone 122039 0
+903382263000
Fax 122039 0
Email 122039 0
[email protected]
Contact person for scientific queries
Name 122040 0
Dr Sükrü Salih Toprak
Address 122040 0
Karaman Egitim ve Arastirma Hastanesi Üniversite mah. 1984. sok. no:1 merkez/Karaman
Country 122040 0
Turkey
Phone 122040 0
+903382260000
Fax 122040 0
Email 122040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17228Ethical approval   



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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