Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464425
Status:
COMPLETED
Last Update Posted:
2011-04-21
First Post:
2007-04-20
Brief Title:
Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery a Randomised Sham-controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 1mgkg 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
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 1mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None