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Colorectal SurgeryPhase 2NCT03711487

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

A Phase 2 study testing Foeniculum Vulgare Seed Ironing in people with Colorectal Surgery and Foeniculum, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colorectal Surgery, Foeniculum, Ileus
What is being tested?
Foeniculum Vulgare Seed Ironing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
20 Oct 2018to 15 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guoxue Road 37#,West China Hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Foeniculum Vulgare Seed Ironing
Keywords
Colorectal surgery, Foeniculum, Ileus
Medical subject headings
Ileus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foeniculum Vulgare Seed IroningDrug

    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.

Study groups in NCT03711487
Study groupRoleWhat they receive
Ironing therapyExperimentalStir-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.
Receives: Drug: Foeniculum Vulgare Seed Ironing
No interventionNo interventionNo intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 30 days after operation.

  2. 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.

    Measured: 4 days after operation

Secondary outcomes (8)

  1. 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).

    Measured: Up to 30 days after operation.

  2. Toleration of drinking water

    Time (hours from end of operation) to toleration of water.

    Measured: Up to 30 days after operation.

  3. Duration of postoperative hospitalization

    Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.

    Measured: Up to 30 days after operation.

  4. 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).

    Measured: During postoperative hospitalization, up to 30 days after operation.

  5. 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.

    Measured: During postoperative hospitalization, up to 30 days after operation.

  6. Short-term complications

    Complications during the 30-day postoperative period

    Measured: Up to 30 days after operation.

  7. Adverse events

    Any adverse events possibly related to treatment with Foeniculum vulgare ironing.

    Measured: Up to 30 days after operation.

  8. Hospitalization costs

    Postoperative in-patients costs

    Measured: During postoperative hospitalization, up to 30 days after operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start20 Oct 2018
  3. Primary completion15 Jun 2019
  4. Study completion15 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711487
Sponsor's protocol ID
FV-GIR-2018
Status last verified
Jul 2019
First submitted
12 Oct 2018
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 15351109

  • 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.

    PubMed 19610681

  • 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.

    PubMed 26867333

  • 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.

    PubMed 20334152

  • 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.

    PubMed 29067571

  • 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.

    PubMed 29621360

  • 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.

    PubMed 16850151

  • 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.

    PubMed 25819420

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Foeniculum Vulgare Seed Ironing in people with Colorectal Surgery and Foeniculum, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flatus time (time frame: Up to 30 days after operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711487, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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