The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
14 september 2019 bijgewerkt door: Ziqiang Wang,MD, West China Hospital
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.
Chinese Medicine Ironing using Foeniculum vulgare has been applied in some departments to promote bowel function recovery, but the efficacy of ironing therapy remains uncertain after colorectal resection surgery.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Postoperative ileus is one of the most common complications after abdominal surgery.
It refers to obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal or nonabdominal surgery.
When the expected period of gastrointestinal recovery time extends beyond what is acceptable, the patient is diagnosed as having a "pathologic" postoperative ileus (POI), which leads to patient discomfort, dissatisfaction, prolonged hospitalization and increased medical expenses.
The incidence of POI is about 17%~24% after abdominal surgery.
Chinese Medicine Ironing using Foeniculum vulgare has been applied in some departments to promote gastrointestinal function recovery as a empiric therapy.
However, the definite efficacy of Foeniculum vulgare ironing therapy（FIT）is uncertain after colorectal resection surgery and whether FIT can reduce the incidence of POI remains unkonown.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
300
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Sichuan
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Chengdu, Sichuan, China, 610041
- Guoxue Road 37#,West China Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Age: 18 ~ 85 years old; sex is not limited.
- Selective operation of colorectal partial resection.
- Participants are volunteered to participate in this study, sign informed consent, and cooperated with follow-up.
Exclusion Criteria:
- Emergency surgery.
- Pregnant or lactating women.
- ASA class 4 or 5 patients.
- Patients with severe abdominal adhesions, which would cost more than 30 minutes to release. Patients with abdominal cocoon disease.
- Patients with peritoneal metastasis or inflammatory bowel disease.
- Patients undergoing enterostomy or total colectomy.
- Patients simultaneously enrolled in any other competing clinical study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Geen tussenkomst
Geen tussenkomst.
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Experimenteel: Ironing therapy
Stir-fry 500 grams of Foeniculum vulgare seeds until the aroma overflows.
Put them into a cotton bag.
Ironing therapy put the bag on abdomen after the temperature is suitable, 30 minutes per time, 4 times daily from 12 hours after surgery and last for 2 days.
The medicine bag can be heated and reused after it cool down.
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Stir-fry 500 grams of Foeniculum vulgare seeds until the aroma overflows.
Put them into a cotton bag.
Ironing therapy put the bag on abdomen after the temperature is suitable, 30 minutes per time, twice daily on postoperative days 2 to 3. The medicine bag can be heated and reused after it cool down.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Flatus time
Tijdsspanne: Up to 30 days after operation.
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Time to faltus (hours from end of operation).
Patients who had stool before any movement of gas were deemed to have an equal time to the time to flatus and first bowel movement.
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Up to 30 days after operation.
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Incidence of postoperative ileus
Tijdsspanne: 4 days after operation
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The same panel defined "prolonged" postoperative ileus as the occurrence of two or more of the following signs and symptoms on postoperative day 4 or after: Nausea or vomiting, Inability to tolerate an oral diet over the preceding 24 hours, Absence of flatus over the preceding 24 hours, Abdominal distention.
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4 days after operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Toleration of a low-residue diet
Tijdsspanne: Up to 30 days after operation.
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Time (hours from end of operation) to tolerate a low-residue diet, defined as consuming >50% of the meal without emesis for 24 hours (time recorded was the time when the patient ate >50% of the meal).
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Up to 30 days after operation.
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Toleration of drinking water
Tijdsspanne: Up to 30 days after operation.
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Time (hours from end of operation) to toleration of water.
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Up to 30 days after operation.
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Duration of postoperative hospitalization
Tijdsspanne: Up to 30 days after operation.
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Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.
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Up to 30 days after operation.
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Pain assessment
Tijdsspanne: During postoperative hospitalization, up to 30 days after operation.
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Assess postoperative pain with the pain visual analogue scale.
Rate the pain levels on a likert scale from 0 (no pain) to 10 (pain as bad as it could possibly be).
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During postoperative hospitalization, up to 30 days after operation.
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Nausea and appetite assessment
Tijdsspanne: During postoperative hospitalization, up to 30 days after operation.
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Rate their appetite and nausea levels on a likert scale from 0 (no appetite, nausea) to 10 (appetite as good as can be, nausea as bad as can be), and each score was recorded separately.
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During postoperative hospitalization, up to 30 days after operation.
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Short-term complications
Tijdsspanne: Up to 30 days after operation.
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Complications during the 30-day postoperative period
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Up to 30 days after operation.
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Adverse events
Tijdsspanne: Up to 30 days after operation.
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Any adverse events possibly related to treatment with Foeniculum vulgare ironing.
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Up to 30 days after operation.
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Hospitalization costs
Tijdsspanne: During postoperative hospitalization, up to 30 days after operation.
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Postoperative in-patients costs
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During postoperative hospitalization, up to 30 days after operation.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Ziqiang Wang, MD, West China Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Choi EM, Hwang JK. Antiinflammatory, analgesic and antioxidant activities of the fruit of Foeniculum vulgare. Fitoterapia. 2004 Sep;75(6):557-65. doi: 10.1016/j.fitote.2004.05.005.
- Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
- Ma HW, Zhao JT, Zhao X. [The Effect of Fennel Tea Drinking on Postoperative Gut Recovery after Gynecological Malignancies Operation]. Sichuan Da Xue Xue Bao Yi Xue Ban. 2015 Nov;46(6):940-3. Chinese.
- Miguel MG, Cruz C, Faleiro L, Simoes MT, Figueiredo AC, Barroso JG, Pedro LG. Foeniculum vulgare essential oils: chemical composition, antioxidant and antimicrobial activities. Nat Prod Commun. 2010 Feb;5(2):319-28.
- Rezayat SM, Dehpour AR, Motamed SM, Yazdanparast M, Chamanara M, Sahebgharani M, Rashidian A. Foeniculum vulgare essential oil ameliorates acetic acid-induced colitis in rats through the inhibition of NF-kB pathway. Inflammopharmacology. 2018 Jun;26(3):851-859. doi: 10.1007/s10787-017-0409-1. Epub 2017 Oct 24.
- Jang SH, Yang DK. The combination of Cassia obtusifolia L. and Foeniculum vulgare M. exhibits a laxative effect on loperamide-induced constipation of rats. PLoS One. 2018 Apr 5;13(4):e0195624. doi: 10.1371/journal.pone.0195624. eCollection 2018. Erratum In: PLoS One. 2018 Aug 9;13(8):e0202259.
- Mattei P, Rombeau JL. Review of the pathophysiology and management of postoperative ileus. World J Surg. 2006 Aug;30(8):1382-91. doi: 10.1007/s00268-005-0613-9.
- Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 oktober 2018
Primaire voltooiing (Werkelijk)
15 juni 2019
Studie voltooiing (Werkelijk)
15 juli 2019
Studieregistratiedata
Eerst ingediend
12 oktober 2018
Eerst ingediend dat voldeed aan de QC-criteria
17 oktober 2018
Eerst geplaatst (Werkelijk)
18 oktober 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2019
Laatste update ingediend die voldeed aan QC-criteria
14 september 2019
Laatst geverifieerd
1 juli 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FV-GIR-2018
Plan Individuele Deelnemersgegevens (IPD)
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NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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