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

Colorectal Surgery Clinical Trial

Official title:

The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711487
• Other study ID #: FV-GIR-2018
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2019
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Colorectal Surgery
• Foeniculum
• Ileus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Guoxue Road 37#,West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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

Outcome

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.