Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Postoperative Ileus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090073
• Other study ID #: CREC 2017.668-T
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 2020

Study information

• Verified date: September 2019
• Source: Chinese University of Hong Kong
• Contact: Simon SM Ng, MD
• Phone: +852-35051495
• Email: simonng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Procedure:
• Electroacupuncture
As above

Other:
• Fast-track Perioperative program
As above

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to defecation	Measured in hours, from the time the laparoscopic surgery ends till the first observed passage of stool.	Up to 1 month
Secondary	Total postoperative hospital stay	Including hospital stay of patients who are readmitted within 30 days after surgery	Up to 1 month
Secondary	Time of first passing flatus reported by the patients		Up to 1 month
Secondary	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	Up to 1 month
Secondary	Time to walk independently		Up to 1 month
Secondary	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	Up to 1 month
Secondary	Postoperative 30-day morbidity	Defined by the Clavien-Dindo classification of surgical complications	Up to 1 month
Secondary	Incidence rate of adverse events related to electroacupuncture		Up to 1 month
Secondary	Readmission rate		Up to 1 month
Secondary	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.	Up to 1 month
Secondary	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.	Up to 1 month
Secondary	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.	Up to 1 month
Secondary	Direct/indirect medical costs and out-of-hospital economic costs		Up to 1 month