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Objective The purpose of this study is to evaluate whether there is a significant difference of early rebleeding rate (within the first 5 days after esophageal variceal ligation), late rebleeding rate (more than 5 days until 28 days after esophageal variceal ligation), and convenience level between cirrhotic patients in early diet group versus late diet group.
Method This study is a single blind randomised clinical trial. Subjects will be selected based on inclusion and exclusion criteria, then the subjects will be randomly divided into 2 groups, the early diet group (clear fluid diet is initiated 1 hour after esophageal variceal ligation) and the late diet group (clear fluid diet is initiated 6 hours after esophageal variceal ligation).
The intervention arm is the early diet group, while the control arm is the late diet group. The primary outcome is the early rebleeding rate. The secondary outcomes are late rebleeding rate and patient's convenience level which will be measured using Visual Analogue Scale (VAS).
Expected result The expected result is there will be no difference in early bleeding rate, late bleeding rate, and convenience level between early diet group versus late diet group.
This study is a single blind randomised controlled trial (RCT) that will be conducted at gastrointestinal endoscopy center division of gastroenterology, integrated procedure room division of hepatobiliary, department of internal medicine, gastroenterology clinic, hepatobiliary clinic, internal medicine ward, high care unit (HCU) and intensive care unit (ICU) Cipto Mangunkusumo Hospital - Faculty of Medicine Universitas Indonesia from May 20, 2021-November 1, 2021. The proposed number of subjects are 130 patients.
Interventions will be given in the form of early clear fluid diet initiation compared to active comparator in the form of late clear fluid diet initiation in eligible liver cirrhosis patients who undergo esophageal variceal ligation (EVL) at Cipto Mangunkusumo Hospital. In early diet group diet, the 100 ml of clear fluid will be initiated at 1 hour after EVL followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. In late diet group, the 100 ml of clear fluid will be initiated at 6 hours after EVL, followed by standard protocol (clear fluid, soft porridge, porridge, soft rice, regular rice) explained in the arms and intervention column below. Other routine and standardised drugs for liver cirrhosis patients will still be given. Statistical analysis will use Chi square test with alternative Fisher test for categorical dependent variables and independent T-test with alternative Mann-Whitney test for two group numerical dependent variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Diet Group | Experimental |
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| Late Diet Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Diet Group | Dietary Supplement | Initiation of clear fluid diet 1 hour after esophageal variceal ligation |
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| Measure | Description | Time Frame |
|---|---|---|
| Early rebleeding event after esophageal variceal ligation | Early rebleeding event is hematemesis, melena and/or hematochezia that occurs within 5 days (120 hours) after esophageal variceal ligation | This outcome (early rebleeding) will be assessed within 5 days after esophageal variceal ligation |
| Measure | Description | Time Frame |
|---|---|---|
| Late rebleeding event after esophageal variceal ligation | Late rebleeding event is hematemesis, melena and/or hematochezia that occurs between over than 5 days until 28 days after esophageal variceal ligation | This outcome (late rebleeding) will be assessed between over than 5 days until 28 days after esophageal variceal ligation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's convenience level regarding initiation of diet after esophageal variceal ligation | Patient's convenience is subjectively measured using Visual Analogue Scale (VAS) 0-10 cm with 0 is very unconvenient and 10 is very convenient | Patient's convenience will be measured 30 minutes after the patient finished the 1st clear fluid diet |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabbinu R Pribadi, MD | Contact | +6285885382231 | rabbinurangga@gmail.com | |
| Megawati Ananda H Putri, MD | Contact | +6281294052702 | megawatianandadr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rabbinu R Pribadi, MD | Dr Cipto Mangunkusumo General Hospital | Principal Investigator |
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| Label | URL |
|---|---|
| Syam AF, Abdullah M, Simadibrata M, Djojoningrat D, Rani A, Manan C. The Causes of Upper Gastrointestinal Bleedingin the National Referral Hospital:Evaluation on Upper Gastrointestinal TractEndoscopic Result in Five Years Period. Indones j gastroenterol. | View source |
| Meseeha M, Attia M. Esophageal Varices. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2020 \[cited 2020 Jul 8\]. | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Late Diet Group | Dietary Supplement | Initiation of clear fluid diet 6 hours after esophageal variceal ligation |
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| Makmun D, Simadibrata M, Fauzi A. Buku Ajar Endoskopi Saluran Cerna. Jakarta: Interna Publishing; 2017. | View source |
| Lo G-H, Lin C-W, Hsu Y-C. A controlled trial of early versus delayed feeding following ligation in the control of acute esophageal variceal bleeding. J Chin Med Assoc JCMA. 2015 Nov;78(11):642-7. | View source |
| Sidhu SS, Goyal O, Singh S, Kishore H, Chhina RS, Sidhu SS. Early feeding after esophageal variceal band ligation in cirrhotics is safe: Randomized controlled trial. Dig Endosc. 2019 Nov;31(6):646-52. | View source |
| Solanki S, Haq K, Chakinala RC,et al. Inpatient burden of esophageal varices in the United States: analysis of trends in demographics, cost of care, and outcomes. Ann Transl Med. 2019 Sep 1;7(18):480. | View source |
| Kalista KF, Lesmana CRA, Sulaiman AS, Gani RA, Hasan I. Profil Klinis Pasien Sirosis Hati dengan Varises Esofagus yang Menjalani Ligasi Varises Esofagus di Rumah Sakit Dr. Cipto Mangunkusumo. J Penyakit Dalam Indones. 2019 Mar 31;6(1):36. | View source |
| Abby Philips C, Sahney A. Oesophageal and gastric varices: historical aspects, classification and grading: everything in one place. Gastroenterol Rep. 2016 Aug;4(3):186-95 | View source |
| . Goda T, Mokhtar A, Anwar R, Hakim H, Eleraki A. Effect of early versus delayed feeding following emergency endoscopic therapy for acute esophageal variceal bleeding on short-term outcomes. Egypt J Intern Med. 2018;30(3):110. | View source |
| Hafeez M. Sucralfate and Lidocain: Antacid 50:50 solution in Post Esophageal Variceal Band Ligation Pain. Pak J Med Sci. 2016 Jul 1;32(4). | View source |
| Klimek L, Bergmann K-C, Biedermann T, Bousquet J, Hellings P, Jung K, et al. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care. | View source |
| Leigheb M, Sabbatini M, Baldrighi M, et al. Prospective analysis of pain and pain management in an emergency department. | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |