Postoperative IleusNCT04090073
Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
A study testing Electroacupuncture and Fast-track Perioperative program in people with Postoperative Ileus, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Background: The investigators' previous study demonstrated that electroacupuncture (EA) reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Electroacupuncture and Fast-track Perioperative program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to Oct 2020
- 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 undergoing elective laparoscopic resection of colonic and upper rectal cancer (adenocarcinoma of the colorectum of which the lowest margin of the tumor is located >12 cm from the anal verge as measured by rigid sigmoidoscopy)
- Age of patients >18 years
- Those with American Society of Anesthesiologists (ASA) grading I-III
- Those with no cognitive impairment (Mini Mental State Examination score 24 out of 30)
- Those with no severe physical disability
- Those who require no assistance with the activities of daily living
- Informed consent available
Who cannot join
- Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy; those with planned stoma creation
- Those undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases
- Those undergoing laparoscopic resection of colorectal cancer with en bloc resection of surrounding organs
- Those who developed intraoperative problems or complications that required conversion
- Those undergoing emergency surgery
- Those with evidence of peritoneal carcinomatosis
Show all 12Show fewer
- Those with previous history of midline laparotomy
- Those who are expected to receive epidural opioids for postoperative pain management
- Those who are pregnant
- Those with cardiac pacemaker
- Those with coagulopathy
- Those who are allergic to the acupuncture needles
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Simon SM Ng, MD, (852) 3505 1495, simonng@surgery.cuhk.edu.hk
Tony WC Mak, MD, (852) 3505 1495, tonymak@surgery.cuhk.edu.hk
About this study
Official title: Electroacupuncture Combined With Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
Background: The investigators' previous study demonstrated that electroacupuncture (EA) reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' (FT) perioperative program may help accelerate recovery after colorectal surgery. It is uncertain whether the combination of EA and FT program will result in faster recovery after laparoscopic colorectal surgery when compared with FT program alone.
Objectives: To compare the efficacy of EA combined with FT program versus FT program alone in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery
Read more
Design: Prospective randomized trial.
Subjects: 72 consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without conversion will be recruited.
Interventions: Patients will be randomly allocated to one of the two groups receiving either EA + FT program, or FT program alone.
Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time to resume diet, pain scores, analgesic requirement, morbidity, quality of life, and medical costs.
Conclusions: This study serves as a good example that illustrates an integrated approach in combining Chinese and Western models of health care. It will provide evidence-based clarification of the role of EA in enhancing recovery after laparoscopic colorectal surgery within a FT perioperative care setting. As laparoscopic colorectal surgery has been shown to have a higher direct cost than the open counterpart, a faster postoperative recovery may help reduce the financial burden to the hospital/healthcare system.
- Conditions
- Postoperative Ileus
- Being tested
- Electroacupuncture, Fast-track Perioperative program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
As above
Fast-track Perioperative programOther
As above
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Plus Fast-track Perioperative Program | Experimental | Patients who are randomized to the intervention arm will receive Electroacupuncture combined with Fast-track program. Each session of Electroacupuncture will last for 20 minutes. The patients will undergo one session of Electroacupuncture daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier. Receives: Procedure: Electroacupuncture; Other: Fast-track Perioperative program |
| Fast-track Perioperative Program | Active comparator | Patients who are randomized to the control arm will receive Fast-track program alone. Receives: Other: Fast-track Perioperative program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to defecation
Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.
Measured: Up to 1 month
Secondary outcomes (12)
Total postoperative hospital stay
Including hospital stay of patients who are readmitted within 30 days after surgery
Measured: Up to 1 month
Time of first passing flatus reported by the patients
Measured: Up to 1 month
Time that the patients tolerated solid diet
Time that the patients tolerated solid diet (any food that required chewing) without vomiting or experiencing significant nausea 4 hours following the meal
Measured: Up to 1 month
Time to walk independently
Measured: Up to 1 month
Pain scores on visual analog scale
From 0 which implies no pain at all, to 100 which implies the worst pain imaginable, on the first 3 postoperative days
Measured: Up to 1 month
Postoperative 30-day morbidity
Defined by the Clavien-Dindo classification of surgical complications
Measured: Up to 1 month
Incidence rate of adverse events related to electroacupuncture
Measured: Up to 1 month
Readmission rate
Measured: Up to 1 month
Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery
SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Up to 1 month
Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 2 and 4 weeks after surgery
EORTC QLQ-C30 is a generic questionnaire for assessment of quality of life (QoL) in cancer patients. It includes 30 items, 24 of which are combined to form a global QoL scale, five functional scales (physical, role, emotional, cognitive, and social), and three symptom scales (fatigue, nausea/vomiting, and pain). The other six single items evaluate dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.
Measured: Up to 1 month
Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery
EORTC QLQ-CR38 is a specific questionnaire module specifically designed for assessment of quality of life (QoL) in patients with colorectal cancer. It consists of 38 items covering symptoms and side effects related to different colorectal cancer treatment modalities. The module contains four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and eight symptom scales/items (micturition problems, chemotherapy side effects, gastrointestinal tract symptoms, male sexual problems, female sexual problems, defecation problems, stoma-related problems, and weight loss). All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.
Measured: Up to 1 month
Direct/indirect medical costs and out-of-hospital economic costs
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 posted16 Sep 2019
- Study start1 Oct 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 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
- NCT04090073
- Sponsor's protocol ID
- CREC 2017.668-T
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 4 Oct 2019
- 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 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Combined With Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04090073
- Acronym / sponsor ID
- CREC 2017.668-T
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Sep 2019 (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.
Background: The investigators' previous study demonstrated that electroacupuncture (EA) reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' (FT) perioperative program may help accelerate recovery after colorectal surgery. It is uncertain whether the combination of EA and FT program will result in faster recovery after laparoscopic colorectal surgery when compared with FT program alone.
Objectives: To compare the efficacy of EA combined with FT program versus FT program alone in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery
Design: Prospective randomized trial.
Subjects: 72 consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer without conversion will be recruited.
Interventions: Patients will be randomly allocated to one of the two groups receiving either EA + FT program, or FT program alone.
Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time to resume diet, pain scores, analgesic requirement, morbidity, quality of life, and medical costs.
Conclusions: This study serves as a good example that illustrates an integrated approach in combining Chinese and Western models of health care. It will provide evidence-based clarification of the role of EA in enhancing recovery after laparoscopic colorectal surgery within a FT perioperative care setting. As laparoscopic colorectal surgery has been shown to have a higher direct cost than the open counterpart, a faster postoperative recovery may help reduce the financial burden to the hospital/healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Plus Fast-track Perioperative Program | Experimental | Procedure: Electroacupuncture, Other: Fast-track Perioperative programPatients who are randomized to the intervention arm will receive Electroacupuncture combined with Fast-track program. Each session of Electroacupuncture will last for 20 minutes. The patients will undergo one session of Electroacupuncture daily from day 1 till day 4, or until the time when the primary outcome has occurred, whichever is earlier. |
| Fast-track Perioperative Program | Active comparator | Other: Fast-track Perioperative programPatients who are randomized to the control arm will receive Fast-track program alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer (adenocarcinoma of the colorectum of which the lowest margin of the tumor is located >12 cm from the anal verge as measured by rigid sigmoidoscopy)
- Age of patients >18 years
- Those with American Society of Anesthesiologists (ASA) grading I-III
- Those with no cognitive impairment (Mini Mental State Examination score 24 out of 30)
- Those with no severe physical disability
Key exclusion criteria (12 listed)
- Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy; those with planned stoma creation
- Those undergoing simultaneous laparoscopic resection of colorectal cancer and other coexisting intraabdominal diseases
- Those undergoing laparoscopic resection of colorectal cancer with en bloc resection of surrounding organs
- Those who developed intraoperative problems or complications 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 |
|---|---|---|
| ElectroacupunctureAs above | Procedure or surgery | Electroacupuncture Plus Fast-track Perioperative Program |
| Fast-track Perioperative programAs above | Other | Electroacupuncture Plus Fast-track Perioperative Program, Fast-track Perioperative Program |
Primary outcome
Time to defecation
Time frame: Up to 1 month
Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.
12 secondary outcomes
Total postoperative hospital stay
Time frame: Up to 1 month
Time of first passing flatus reported by the patients
Time frame: Up to 1 month
Time that the patients tolerated solid diet
Time frame: Up to 1 month
Time to walk independently
Time frame: Up to 1 month
Pain scores on visual analog scale
Time frame: Up to 1 month
Postoperative 30-day morbidity
Time frame: Up to 1 month
Incidence rate of adverse events related to electroacupuncture
Time frame: Up to 1 month
Readmission rate
Time frame: Up to 1 month
Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 2 and 4 weeks after surgery
Time frame: Up to 1 month
Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 2 and 4 weeks after surgery
Time frame: Up to 1 month
Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 2 and 4 weeks after surgery
Time frame: Up to 1 month
Direct/indirect medical costs and out-of-hospital economic costs
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 4 Oct 2019.
- 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 and Fast-track Perioperative program in people with Postoperative Ileus, run by Chinese University of Hong Kong at 1 site in China.
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 7 inclusion and 12 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 4 Oct 2019. 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 China. 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. 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 (+852-35051495, 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?
Time to defecation (time frame: Up to 1 month). 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 4 Oct 2019.