The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
2019년 9월 14일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
300
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- Guoxue Road 37#,West China Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 개입 없음
개입하지 않습니다.
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Flatus time
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Toleration of a low-residue diet
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Ziqiang Wang, MD, West China Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 10월 20일
기본 완료 (실제)
2019년 6월 15일
연구 완료 (실제)
2019년 7월 15일
연구 등록 날짜
최초 제출
2018년 10월 12일
QC 기준을 충족하는 최초 제출
2018년 10월 17일
처음 게시됨 (실제)
2018년 10월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 14일
마지막으로 확인됨
2019년 7월 1일
추가 정보
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