Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00464425
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Completed
Phase Phase 3
Start date October 2008
Completion date October 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT02232893 - Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy Phase 2
Not yet recruiting NCT05001763 - Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy Phase 2
Active, not recruiting NCT04547868 - Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery N/A
Completed NCT02815956 - Tibial Nerve Stimulation and Postoperative Ileus N/A
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT05512741 - Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
Recruiting NCT04675606 - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies N/A
Completed NCT02161367 - Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery Phase 4
Completed NCT01956643 - Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation N/A
Completed NCT00402961 - Trial of Acupuncture for Reduction of Post-Colectomy Ileus Phase 2
Terminated NCT04100265 - ANTERO-5: Gastric Motility in Postoperative Ileus N/A
Recruiting NCT04090073 - Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery N/A
Recruiting NCT03222557 - Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer N/A
Withdrawn NCT02261454 - RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children N/A
Completed NCT02639728 - The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery. N/A
Completed NCT02004652 - Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery Phase 2
Completed NCT00509327 - Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery Phase 4
Completed NCT03097900 - Does Caffeine Enhance Bowel Recovery After Colorectal Surgery? Phase 2
Completed NCT03143621 - The Effect of Coffee After Resection of Small Bowel N/A