Postoperative Ileus
Conditions
Brief summary
Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery. The investigators previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic resection of colonic and upper rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex cases are more likely to develop prolonged ileus and morbidity after surgery, and it is uncertain whether EA will be beneficial to them. The investigators therefore propose to conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative day 1 till day 4. These patients will be compared with a matched historical control group (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. Secondary outcomes include time to defecation and duration of hospital stay. Results of this study will help clarify the efficacy of EA in preventing prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a larger randomized controlled trial.
Interventions
PROCEDUREElectroacupuncture
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive patients (aged between 18 and 80) with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion * Patients with American Society of Anesthesiologists grading I-III * Informed consent available
Exclusion criteria
* Patients undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases * Patients undergoing laparoscopic resection of rectal cancer with en-bloc resection of surrounding organs * Patients who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion * Patients with intestinal obstruction * Patients with previous history of abdominal surgery * Patients with evidence of peritoneal carcinomatosis * Patients who are expected to receive epidural anesthesia or analgesia * Patients with cardiac pacemaker * Patients who are pregnant * Patients who are allergic to acupuncture needles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of prolonged ileus | Up to 1 month | Defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first defecation | Up to 1 month | — |
| Time that the patients tolerated solid diet | Up to 1 month | — |
| Duration of hospital stay | Up to 1 month | — |
| Time of first passing flatus reported by the patients | Up to 1 month | — |
| Postoperative analgesic requirement | Up to 1 month | — |
| Overall complication rate | Up to 1 month | — |
| 30-day mortality rate | Up to 1 month | — |
| Pain scores on visual analog scale | Up to 3 days | From 0 which implies no pain at all, to 10 which implies the worst pain imaginable |
Countries
China
Contacts
Primary ContactSimon SM Ng, MD
Backup ContactWing Wa Leung, MSc
Outcome results
None listed