Postoperative IleusNCT03222557
Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer
A study testing Electroacupuncture in people with Postoperative Ileus and Rectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective, randomized, sham-controlled, superiority trial that aimed to investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal resection for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Rectal Cancer
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients (aged between 18 and 80) with mid/low rectal cancer (adenocarcinoma in the rectum of which the lowest margin of the tumor is located within 12 cm of the anal verge as measured by rigid sigmoidoscopy) undergoing laparoscopic sphincter-preserving TME or APR without the need of conversion
- American Society of Anesthesiologists grading I-III
- Informed consent available
Who cannot join
- Patients with previous experience of acupuncture
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Simon SM Ng, MD, (852) 3505 1495, simonng@surgery.cuhk.edu.hk
About this study
Official title: Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer: A Prospective, Randomized, Sham-controlled Trial
This is a prospective, randomized, sham-controlled, superiority trial that aimed to investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal resection for rectal cancer.
Read the detailed description
Background: Postoperative ileus (POI) remains a significant problem after colorectal surgery that adversely influences patients' recovery and prolongs hospital stay. The investigators' previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of POI and hospital stay after laparoscopic resection of colonic and upper rectal cancer (Ng et al. Gastroenterology 2013; 144: 307-313). However, patients with mid/low rectal cancer undergoing laparoscopic sphincter-preserving total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. These complicated cases are apparently more likely to develop prolonged ileus and morbidity after surgery.
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
- Postoperative Ileus, Rectal Cancer
- Being tested
- Electroacupuncture, Sham Acupuncture
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Also called EA
Refer to arm description
Sham AcupunctureProcedure or surgery
Also called SA
Refer to arm description
ElectroacupunctureDevice
Also called EA
Refer to arm description
Sham AcupunctureDevice
Also called SA
Refer to arm description
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) | Experimental | 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 Receives: Procedure: Electroacupuncture; Device: Electroacupuncture |
| Sham Acupuncture (SA) | Sham comparator | 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. Receives: Procedure: Sham Acupuncture; Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI-2 recovery
A composite assessment that measured upper (first tolerance of solid food) and lower (first bowel movement) GI tract recovery, with time to achieve GI-2 recovery based on the last event to occur
Measured: Up to 10 days
Secondary outcomes (6)
Time of first passing flatus
Measured: Up to 10 days
Length of hospital stay
Measured: Up to 1 month
Pain scores on the first 3 postoperative days
On visual analog scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable)
Measured: Up to postoperative day 3
Postoperative analgesic requirement
Measured: Up to 1 month
Short-term morbidity
Defined by the Clavien-Dindo classification of surgical complications
Measured: Up to 1 month
Adverse events related to EA/SA
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startNov 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222557
- Sponsor's protocol ID
- CREC Ref. No.: 2017.010-T
- Status last verified
- Oct 2017
- First submitted
- 14 Jul 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer: A Prospective, Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03222557
- Acronym / sponsor ID
- CREC Ref. No.: 2017.010-T
- Conditions
- Postoperative Ileus, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, sham-controlled, superiority trial that aimed to investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal resection for rectal cancer.
Detailed description
Background: Postoperative ileus (POI) remains a significant problem after colorectal surgery that adversely influences patients' recovery and prolongs hospital stay. The investigators' previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of POI and hospital stay after laparoscopic resection of colonic and upper rectal cancer (Ng et al. Gastroenterology 2013; 144: 307-313). However, patients with mid/low rectal cancer undergoing laparoscopic sphincter-preserving total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. These complicated cases are apparently more likely to develop prolonged ileus and morbidity after surgery.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) | Experimental | Procedure: Electroacupuncture, Device: ElectroacupunctureBilateral 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 |
| Sham Acupuncture (SA) | Sham comparator | Procedure: Sham Acupuncture, Device: Sham AcupunctureSterile 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients (aged between 18 and 80) with mid/low rectal cancer (adenocarcinoma in the rectum of which the lowest margin of the tumor is located within 12 cm of the anal verge as measured by rigid sigmoidoscopy) undergoing laparoscopic sphincter-preserving TME or APR without the need of conversion
- American Society of Anesthesiologists grading I-III
- Informed consent available
Key exclusion criteria (11 listed)
- Patients with previous experience of acupuncture
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: EARefer to arm description | Procedure or surgery | Electroacupuncture (EA) |
| Sham AcupunctureAlso: SARefer to arm description | Procedure or surgery | Sham Acupuncture (SA) |
| ElectroacupunctureAlso: EARefer to arm description | Device | Electroacupuncture (EA) |
| Sham AcupunctureAlso: SARefer to arm description | Device | Sham Acupuncture (SA) |
Primary outcome
GI-2 recovery
Time frame: Up to 10 days
A composite assessment that measured upper (first tolerance of solid food) and lower (first bowel movement) GI tract recovery, with time to achieve GI-2 recovery based on the last event to occur
6 secondary outcomes
Time of first passing flatus
Time frame: Up to 10 days
Length of hospital stay
Time frame: Up to 1 month
Pain scores on the first 3 postoperative days
Time frame: Up to postoperative day 3
Postoperative analgesic requirement
Time frame: Up to 1 month
Short-term morbidity
Time frame: Up to 1 month
Adverse events related to EA/SA
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon SM Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Postoperative Ileus and Rectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon SM Ng, MD ((852) 3505 1495, simonng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI-2 recovery (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.