Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
A Randomized Clinical Trial of Electroacupuncture Versus Fast-track Perioperative Program for Reducing Duration of Postoperative Ileus and Hospital Stay After Laparoscopic Colorectal Surgery
Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou 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' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.
Design: Prospective, randomized, noninferiority trial.
Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.
Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.
Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.
Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.
연구 개요
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Hong Kong, 중국
- 모병
- Prince of Wales Hospital, the Chinese University of Hong Kong
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부수사관:
- Tony WC Mak, MD
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연락하다:
- Tony WC Mak, MD
- 전화번호: (852) 2632 1495
- 이메일: tonymak@surgery.cuhk.edu.hk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer
- Age of patients between 18 and 80 years
- Patients with American Society of Anesthesiologists (ASA) grading I-II
- Patients with no severe physical disability
- Patients 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
- Patients with planned stoma creation
- Patients undergoing emergency surgery
- Patients with evidence of peritoneal carcinomatosis
- Patients with previous history of midline laparotomy
- Patients who are expected to receive epidural opioids for postoperative pain management
- Patients with cardiac pacemaker
- Patients who are allergic to the acupuncture needles
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Electroacupuncture
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 acupuncture needles.
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활성 비교기: Fast-track program
The design of this program is based on the consensus between our surgeons, anesthetists, physiotherapists, dietitians, and nurses, who have reviewed the relevant literature and made appropriate adjustments to suit the local situation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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배변 시간
기간: 최대 1개월
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복강경 수술이 끝나는 시간부터 처음 관찰된 대변 통과까지 시간 단위로 측정됩니다.
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최대 1개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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환자가 보고한 최초의 방귀 통과 시간
기간: 최대 1개월
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최대 1개월
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환자가 고형식을 견딘 시간
기간: 최대 1개월
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최대 1개월
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독립적으로 걷는 시간
기간: 최대 1개월
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최대 1개월
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재입학률
기간: 최대 1개월
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최대 1개월
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Total postoperative hospital stay
기간: Up to 1 month
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Including hospital stay of patients who are readmitted within 30 days after surgery.
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Up to 1 month
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Pain scores on visual analog scale
기간: Up to 1 month
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From 0 which implies no pain at all, to 100 which implies the worst pain imaginable; assessed at 4, 12, 24, 48, and 72 hours after surgery.
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Up to 1 month
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Morbidity
기간: Up to 1 month
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Up to 1 month
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Mortality
기간: Up to 1 month
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Up to 1 month
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Quality of life
기간: Up to 1 month
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Quality of life at 2 and 4 weeks after surgery, measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
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Up to 1 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Simon S. M. Ng, MD, Chinese University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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