The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
2019年9月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
300
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Sichuan
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Chengdu、Sichuan、中国、610041
- Guoxue Road 37#,West China Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：介入なし
介入なし。
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Flatus time
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Toleration of a low-residue diet
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Ziqiang Wang, MD、West China Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年10月20日
一次修了 (実際)
2019年6月15日
研究の完了 (実際)
2019年7月15日
試験登録日
最初に提出
2018年10月12日
QC基準を満たした最初の提出物
2018年10月17日
最初の投稿 (実際)
2018年10月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月17日
QC基準を満たした最後の更新が送信されました
2019年9月14日
最終確認日
2019年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。