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

Primary Purpose

Colorectal Surgery, Foeniculum, Ileus

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Foeniculum Vulgare Seed Ironing
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Surgery focused on measuring Colorectal surgery, Foeniculum, Ileus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guoxue Road 37#,West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ironing therapy

No intervention

Arm Description

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.

No intervention.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
Toleration of drinking water
Time (hours from end of operation) to toleration of water.
Duration of postoperative hospitalization
Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.
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).
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.
Short-term complications
Complications during the 30-day postoperative period
Adverse events
Any adverse events possibly related to treatment with Foeniculum vulgare ironing.
Hospitalization costs
Postoperative in-patients costs

Full Information

First Posted
October 12, 2018
Last Updated
September 14, 2019
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03711487
Brief Title
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
Official Title
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery, Foeniculum, Ileus
Keywords
Colorectal surgery, Foeniculum, Ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ironing therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Drug
Intervention Name(s)
Foeniculum Vulgare Seed Ironing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Flatus time
Description
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.
Time Frame
Up to 30 days after operation.
Title
Incidence of postoperative ileus
Description
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.
Time Frame
4 days after operation
Secondary Outcome Measure Information:
Title
Toleration of a low-residue diet
Description
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).
Time Frame
Up to 30 days after operation.
Title
Toleration of drinking water
Description
Time (hours from end of operation) to toleration of water.
Time Frame
Up to 30 days after operation.
Title
Duration of postoperative hospitalization
Description
Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.
Time Frame
Up to 30 days after operation.
Title
Pain assessment
Description
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).
Time Frame
During postoperative hospitalization, up to 30 days after operation.
Title
Nausea and appetite assessment
Description
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.
Time Frame
During postoperative hospitalization, up to 30 days after operation.
Title
Short-term complications
Description
Complications during the 30-day postoperative period
Time Frame
Up to 30 days after operation.
Title
Adverse events
Description
Any adverse events possibly related to treatment with Foeniculum vulgare ironing.
Time Frame
Up to 30 days after operation.
Title
Hospitalization costs
Description
Postoperative in-patients costs
Time Frame
During postoperative hospitalization, up to 30 days after operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guoxue Road 37#,West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15351109
Citation
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.
Results Reference
result
PubMed Identifier
19610681
Citation
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.
Results Reference
result
PubMed Identifier
26867333
Citation
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.
Results Reference
result
PubMed Identifier
20334152
Citation
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.
Results Reference
result
PubMed Identifier
29067571
Citation
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.
Results Reference
result
PubMed Identifier
29621360
Citation
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. Erratum In: PLoS One. 2018 Aug 9;13(8):e0202259.
Results Reference
result
PubMed Identifier
16850151
Citation
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.
Results Reference
result
PubMed Identifier
25819420
Citation
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.
Results Reference
result

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

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