Clinical trial NCT03711487: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Surgery
Foeniculum
Ileus
Keywords: Colorectal surgery
Foeniculum
Ileus
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Flatus time
timeFrame: Up to 30 days after operation.
measure: Incidence of postoperative ileus
timeFrame: 4 days after operation
Secondary outcomes:
measure: Toleration of a low-residue diet
timeFrame: Up to 30 days after operation.
measure: Toleration of drinking water
timeFrame: Up to 30 days after operation.
measure: Duration of postoperative hospitalization
timeFrame: Up to 30 days after operation.
measure: Pain assessment
timeFrame: During postoperative hospitalization, up to 30 days after operation.
measure: Nausea and appetite assessment
timeFrame: During postoperative hospitalization, up to 30 days after operation.
measure: Short-term complications
timeFrame: Up to 30 days after operation.
measure: Adverse events
timeFrame: Up to 30 days after operation.
measure: Hospitalization costs
timeFrame: During postoperative hospitalization, up to 30 days after operation.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Guoxue Road 37#,West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ziqiang Wang, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.