NCT03711487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

September 17, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

October 12, 2018

Last Update Submit

September 14, 2019

Conditions

Colorectal SurgeryFoeniculumIleus

Keywords

Colorectal surgeryFoeniculumIleus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Toleration of a low-residue diet

    Up to 30 days after operation.

  • Toleration of drinking water

    Up to 30 days after operation.

  • Duration of postoperative hospitalization

    Up to 30 days after operation.

  • Pain assessment

    During postoperative hospitalization, up to 30 days after operation.

  • Nausea and appetite assessment

    During postoperative hospitalization, up to 30 days after operation.

  • +3 more secondary outcomes

Study Arms (2)

Ironing therapy

EXPERIMENTAL

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

No intervention

NO INTERVENTION

No intervention.

Interventions

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.

Ironing therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (8)

  • 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.

    PMID: 15351109RESULT

  • 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.

    PMID: 19610681RESULT

  • 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.

    PMID: 26867333RESULT

  • 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.

    PMID: 20334152RESULT

  • 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.

    PMID: 29067571RESULT

  • 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.

    PMID: 29621360RESULT

  • 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.

    PMID: 16850151RESULT

  • 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.

    PMID: 25819420RESULT

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ziqiang Wang, MD

    West China Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 18, 2018

Study Start

October 20, 2018

Primary Completion

June 15, 2019

Study Completion

July 15, 2019

Last Updated

September 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)