Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer
NCT ID: NCT03222557
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
164 participants
INTERVENTIONAL
2017-11-30
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objectives: To investigate the efficacy of EA in reducing the duration of POI and hospital stay after laparoscopic TME or APR for rectal cancer.
Hypothesis: Rectal cancer patients undergoing laparoscopic TME or APR within a fast-track perioperative program who receive EA will have shorter duration of POI and hospital stay when compared with those who receive sham acupuncture (SA).
Design: Prospective, randomized, sham-controlled, superiority trial.
Subjects: One hundred and sixty four consecutive patients with mid/low rectal cancer undergoing laparoscopic surgery without the need of conversion will be recruited. All patients will follow a standard perioperative fast-track program.
Interventions: Patients will be randomly allocated to receive either EA or SA. Bilateral acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou will be used. The acupuncturist is the only individual who is aware of the treatment allocation; the patients randomized to the EA/SA groups and the outcome assessor are blinded to the treatment allocation. The patients will undergo one session of EA daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier.
Outcome measures: Primary outcome: a composite endpoint of time to recovery of upper and lower gastrointestinal function (GI-2). Secondary outcomes: time to discharge order written, length of hospital stay, postoperative pain scores and analgesic requirement, and postoperative 30-day morbidity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Electroacupuncture (EA)
Bilateral acupoints relevant to the treatment of abdominal pain, 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. Electric stimulation at a frequency of 50 Hz will be employed to the needles
Electroacupuncture
Refer to arm description
Electroacupuncture
Refer to arm description
Sham Acupuncture (SA)
Sterile blunt-tip needles will be placed (without skin penetration) 20 mm away from the acupoints. The needle will be first inserted through a sterile plastic tube mounted on a foam block, and then pressed on the skin. The foam block compresses to give the impression that the needle is penetrating the skin, thus providing a SA effect. 'Pseudostimulation' will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.
Sham Acupuncture
Refer to arm description
Sham Acupuncture
Refer to arm description
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Electroacupuncture
Refer to arm description
Sham Acupuncture
Refer to arm description
Electroacupuncture
Refer to arm description
Sham Acupuncture
Refer to arm description
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American Society of Anesthesiologists grading I-III
* Informed consent available
Exclusion Criteria
* Those undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases
* Those undergoing laparoscopic resection of rectal cancer with en bloc resection of surrounding organs
* Those who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion
* Those undergoing emergency surgery
* Those with previous history of midline laparotomy
* Those with evidence of peritoneal carcinomatosis
* Those who are expected to receive epidural anesthesia or analgesia
* Those with cardiac pacemaker
* Those who are pregnant
* Those who are allergic to the acupuncture needles
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chinese University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Simon S. M. Ng
Professor of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Simon SM Ng, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Simon SM Ng, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CREC Ref. No.: 2017.010-T
Identifier Type: -
Identifier Source: org_study_id