Postoperative Ileus Clinical Trial
Official title:
Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery: a Randomised Sham-controlled Pilot Study
Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery and prolongs hospital stay. In fact, a substantial portion of the overall hospitalisation period after colorectal surgery is attributed to the time it takes for ileus to resolve. Although laparoscopic colorectal surgery has been proven to be associated with better short-term clinical outcomes including faster return of gastrointestinal function than open surgery, the duration of postoperative ileus in the laparoscopic arm is still reported to be as long as 4 days in most of the randomised trials. Additional measures are thus necessary to further enhance the gastrointestinal recovery after laparoscopic colorectal surgery in order to maximise its benefits, and acupuncture may be one of the options. Acupuncture is widely accepted in China as well as throughout the world as an effective treatment option for the management of postoperative nausea and vomiting and various functional gastrointestinal disorders. Its role in treating postoperative ileus, however, is less clear, and data from the Chinese as well as the Western literature are scarce. We therefore propose to carry out a prospective randomised sham-controlled pilot study to assess the efficacy of electroacupuncture in treating postoperative ileus after laparoscopic colorectal surgery. The acupoints relevant to the treatment of abdominal distension and constipation, including Zusanli (stomach meridian ST-36), Sanyinjiao (spleen meridian SP-6), Hegu (large intestine meridian LI-4), and Zhigou (triple energizer meridian TE-6) will be used.
Postoperative ileus remains a significant medical problem after colorectal surgery that
adversely influences patients' recovery and prolongs hospital stay. In fact, a substantial
portion of the overall hospitalisation period after colorectal surgery is attributed to the
time it takes for ileus to resolve. Different treatment modalities including thoracic
epidural analgesia, pharmacological therapy, early enteral feeding, and early mobilisation
have been attempted, but none has an established role as a specific remedy for postoperative
ileus. Although laparoscopic colorectal surgery has been proven to be associated with better
short-term clinical outcomes including faster return of gastrointestinal function than open
surgery, the duration of postoperative ileus in the laparoscopic arm is still reported to be
as long as 4 days (which is just about 1 day earlier than that in the open arm) in most of
the randomised trials. Additional measures are thus necessary to further enhance the
gastrointestinal recovery after laparoscopic colorectal surgery in order to maximise its
benefits, and acupuncture may be one of the options. Acupuncture is widely accepted in China
as well as throughout the world as an effective treatment option for the management of
postoperative nausea and vomiting and various functional gastrointestinal disorders. Its
role in treating postoperative ileus, however, is less clear, and data from the Chinese as
well as the Western literature are scarce. Besides, the heterogeneity of the study designs
and flaws in methodology of the reported studies have made interpretation of these data
difficult. Results of the present study can provide evidence-based clarification of the role
of acupuncture in treating postoperative ileus after laparoscopic colorectal surgery. If the
hypothesis is proven to be correct and substantiated by further studies, the incorporation
of electroacupuncture into any fast-track recovery programmes after laparoscopic, open, or
even emergency colorectal surgery should be considered. As laparoscopic colorectal surgery
has been shown to have higher direct cost than the open counterpart, a faster postoperative
recovery may help to reduce the financial burden to the hospital and improve the
cost-effectiveness of the procedure.
Patients will be enrolled into the study if all the inclusion and exclusion criteria are
satisfied after the laparoscopic surgery. Randomisation will be done shortly after surgery.
Patients will be randomised to receive either electroacupuncture (EA group), sham
acupuncture (SA group), or no acupuncture (NA group). The medical acupuncturist is the only
individual who is aware of the treatment allocation; patients of the EA and SA groups are
blinded to the treatment. The patients randomised to the EA and SA groups will undergo 1
session of acupuncture daily from postoperative day 1 till day 4. Adverse events associated
with acupuncture including bleeding, dizziness, excessive pain, and allergic reaction will
be closely monitored. The acupuncture needle will be immediately withdrawn if these events
occur.
The postoperative management of all patients will be standardised. Pethidine 1mg/kg as
postoperative analgesia will be given every 4-hourly on demand. Early ambulation will be
encouraged. Oral feeding will be resumed as soon as gastrointestinal function returns
clinically (no nausea or vomiting, no abdominal distension, passage of flatus or stool). No
gum chewing will be allowed. Patients will be discharged when they tolerate diet and are
fully ambulatory.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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