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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ileus, Colorectal Surgery, Foeniculum

Intervention / Treatment
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* Drug: Foeniculum Vulgare Seed Ironing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ironing therapy<br>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<br>* 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.<br>|
| No Intervention: No intervention<br>No intervention. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Foeniculum, Ileus