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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
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.
Guoxue Road 37#,West China Hospital
Chengdu, Sichuan, China
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.
Time frame: 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.
Time frame: 4 days after operation
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).
Time frame: Up to 30 days after operation.
Toleration of drinking water
Time (hours from end of operation) to toleration of water.
Time frame: Up to 30 days after operation.
Duration of postoperative hospitalization
Postoperative days the patient was ready for hospital discharge based on Gastrointestinal function alone.
Time frame: Up to 30 days after operation.
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).
Time frame: During postoperative hospitalization, up to 30 days after operation.
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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.
Time frame: During postoperative hospitalization, up to 30 days after operation.
Short-term complications
Complications during the 30-day postoperative period
Time frame: Up to 30 days after operation.
Adverse events
Any adverse events possibly related to treatment with Foeniculum vulgare ironing.
Time frame: Up to 30 days after operation.
Hospitalization costs
Postoperative in-patients costs
Time frame: During postoperative hospitalization, up to 30 days after operation.