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The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection

14. september 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

300

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Guoxue Road 37#,West China Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age: 18 ~ 85 years old; sex is not limited.
  2. Selective operation of colorectal partial resection.
  3. Participants are volunteered to participate in this study, sign informed consent, and cooperated with follow-up.

Exclusion Criteria:

  1. Emergency surgery.
  2. Pregnant or lactating women.
  3. ASA class 4 or 5 patients.
  4. Patients with severe abdominal adhesions, which would cost more than 30 minutes to release. Patients with abdominal cocoon disease.
  5. Patients with peritoneal metastasis or inflammatory bowel disease.
  6. Patients undergoing enterostomy or total colectomy.
  7. Patients simultaneously enrolled in any other competing clinical study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Ingen indgriben
Ingen indgriben.
Eksperimentel: 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.
Medicin: Foeniculum Vulgare Seed Ironing
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Flatus time
Tidsramme: Up to 30 days after operation.
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.
Up to 30 days after operation.
Incidence of postoperative ileus
Tidsramme: 4 days after operation
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.
4 days after operation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Toleration of a low-residue diet
Tidsramme: Up to 30 days after operation.
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).
Up to 30 days after operation.
Toleration of drinking water
Tidsramme: Up to 30 days after operation.
Time (hours from end of operation) to toleration of water.
Up to 30 days after operation.
Duration of postoperative hospitalization
Tidsramme: Up to 30 days after operation.
Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.
Up to 30 days after operation.
Pain assessment
Tidsramme: During postoperative hospitalization, up to 30 days after operation.
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).
During postoperative hospitalization, up to 30 days after operation.
Nausea and appetite assessment
Tidsramme: During postoperative hospitalization, up to 30 days after operation.
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.
During postoperative hospitalization, up to 30 days after operation.
Short-term complications
Tidsramme: Up to 30 days after operation.
Complications during the 30-day postoperative period
Up to 30 days after operation.
Adverse events
Tidsramme: Up to 30 days after operation.
Any adverse events possibly related to treatment with Foeniculum vulgare ironing.
Up to 30 days after operation.
Hospitalization costs
Tidsramme: During postoperative hospitalization, up to 30 days after operation.
Postoperative in-patients costs
During postoperative hospitalization, up to 30 days after operation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

West China Hospital

Efterforskere

  • Studiestol: Ziqiang Wang, MD, West China Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. oktober 2018

Primær færdiggørelse (Faktiske)

15. juni 2019

Studieafslutning (Faktiske)

15. juli 2019

Datoer for studieregistrering

Først indsendt

12. oktober 2018

Først indsendt, der opfyldte QC-kriterier

17. oktober 2018

Først opslået (Faktiske)

18. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FV-GIR-2018

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