Colorectal Surgery Clinical Trial
Official title:
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.
Verified date | July 2019 |
Source | West China Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | July 15, 2019 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Guoxue Road 37#,West China Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
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. Review. — View Citation
Choi EM, Hwang JK. Antiinflammatory, analgesic and antioxidant activities of the fruit of Foeniculum vulgare. Fitoterapia. 2004 Sep;75(6):557-65. — View Citation
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. — View Citation
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 i — View Citation
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. — View Citation
Mattei P, Rombeau JL. Review of the pathophysiology and management of postoperative ileus. World J Surg. 2006 Aug;30(8):1382-91. Review. — View Citation
Miguel MG, Cruz C, Faleiro L, Simões 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. — View Citation
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):85 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flatus time | 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. | |
Primary | Incidence of postoperative ileus | 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 | |
Secondary | Toleration of a low-residue diet | 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. | |
Secondary | Toleration of drinking water | Time (hours from end of operation) to toleration of water. | Up to 30 days after operation. | |
Secondary | Duration of postoperative hospitalization | Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone. | Up to 30 days after operation. | |
Secondary | Pain assessment | 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. | |
Secondary | Nausea and appetite assessment | 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. | |
Secondary | Short-term complications | Complications during the 30-day postoperative period | Up to 30 days after operation. | |
Secondary | Adverse events | Any adverse events possibly related to treatment with Foeniculum vulgare ironing. | Up to 30 days after operation. | |
Secondary | Hospitalization costs | Postoperative in-patients costs | During postoperative hospitalization, up to 30 days after operation. |
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