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

Phase 2

Completed

• Conditions: Colorectal Surgery; Foeniculum; Ileus
• Interventions: Drug: Foeniculum Vulgare Seed Ironing

• Registration Number: NCT03711487
• Lead Sponsor: West China Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-18
• Study Start: 2018-10-20
• Primary Completion: 2019-06-15
• Status Verified: 2019-07
• Study Completion: 2019-07-15
• Last Update Submitted: 2019-09-14
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ironing therapy	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, 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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative ileus	4 days after operation	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.
Flatus time	Up to 30 days after operation.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guoxue Road 37#,West China Hospital; 🇨🇳 Chengdu, Sichuan, China