Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer

NCT03222557 | Unknown DMC

• 1 other identifier: CREC Ref. No.: 2017.010-T
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Ileus; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 10 days

Secondary Outcomes (6)

• Time of first passing flatus

  Up to 10 days

• Length of hospital stay

  Up to 1 month

• Pain scores on the first 3 postoperative days

  Up to postoperative day 3

• Postoperative analgesic requirement

  Up to 1 month

• Short-term morbidity

  Up to 1 month

Study Arms (2)

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

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.

Procedure: Sham Acupuncture; Device: Sham Acupuncture

Interventions

Electroacupuncture PROCEDURE

Refer to arm description

Also known as: EA

Electroacupuncture (EA)

Sham Acupuncture PROCEDURE

Refer to arm description

Also known as: SA

Sham Acupuncture (SA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon SM Ng, MD

CONTACT

(852) 3505 1495; simonng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 19, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)