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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711487
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Surgery Foeniculum Ileus Drug: Foeniculum Vulgare Seed Ironing Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.
Actual Study Start Date : October 20, 2018
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
No Intervention: No intervention
No intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Flatus time [ Time Frame: 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.

  2. Incidence of postoperative ileus [ Time Frame: 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.


Secondary Outcome Measures :
  1. Toleration of a low-residue diet [ Time Frame: 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).

  2. Toleration of drinking water [ Time Frame: Up to 30 days after operation. ]
    Time (hours from end of operation) to toleration of water.

  3. Duration of postoperative hospitalization [ Time Frame: Up to 30 days after operation. ]
    Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.

  4. Pain assessment [ Time Frame: 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).

  5. Nausea and appetite assessment [ Time Frame: 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.

  6. Short-term complications [ Time Frame: Up to 30 days after operation. ]
    Complications during the 30-day postoperative period

  7. Adverse events [ Time Frame: Up to 30 days after operation. ]
    Any adverse events possibly related to treatment with Foeniculum vulgare ironing.

  8. Hospitalization costs [ Time Frame: During postoperative hospitalization, up to 30 days after operation. ]
    Postoperative in-patients costs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711487


Locations
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China, Sichuan
Guoxue Road 37#,West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Study Chair: Ziqiang Wang, MD West China Hospital
More Information
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Publications of Results:

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Responsible Party: Ziqiang Wang,MD, professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03711487    
Other Study ID Numbers: FV-GIR-2018
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziqiang Wang,MD, West China Hospital:
Colorectal surgery
Foeniculum
Ileus
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases