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Completed

NCT Number: NCT03711487

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foeniculum Vulgare Seed Ironing

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection: a Randomized Controlled Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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