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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Ileus; Foeniculum
• Intervention / Treatment: Drug: Foeniculum Vulgare Seed Ironing

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; No intervention.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Toleration of drinking water	Time (hours from end of operation) to toleration of water.	Up to 30 days after operation.
Duration of postoperative hospitalization	Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.	Up to 30 days after operation.
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.
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.
Short-term complications	Complications during the 30-day postoperative period	Up to 30 days after operation.
Adverse events	Any adverse events possibly related to treatment with Foeniculum vulgare ironing.	Up to 30 days after operation.
Hospitalization costs	Postoperative in-patients costs	During postoperative hospitalization, up to 30 days after operation.

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: Ziqiang Wang, MD, West China Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2018
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Colorectal surgery; Ileus; Foeniculum
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: FV-GIR-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No