Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Laparoscopic Colorectal Surgery in Hong Kong Chinese Patients: A Prospective Randomized Trial
Background:
Laparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been introduced in the West to optimize perioperative factors to reduce the physiological/psychological stress of open colorectal surgery. However, few studies have evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal surgery.
Objective:
To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track" perioperative program.
Design:
Prospective randomized trial.
Subjects:
One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection of non-metastatic colonic and upper rectal cancer will be recruited.
Interventions:
Patients will be randomized to a "traditional" or a "fast-track" perioperative program.
Outcome measures:
Primary outcome: total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters (including systemic cytokine response and cell-mediated immune function), morbidity and mortality, quality of life, and medical costs.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Hong Kong, 중국
- Prince of Wales Hospital, the Chinese University of Hong Kong
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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 75 years
- Patients with American Society of Anesthesiologists 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 known metastatic disease
- Patients with previous history of abdominal surgery
- Patients with known immunological dysfunction
- Patients who are taking steroids or immunosuppressive agents
- Patients with chronic pain syndrome
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: Fast-track perioperative program
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Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization
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활성 비교기: Traditional perioperative program
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Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of hospital stay
기간: Up to 1 month
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Total postoperative hospital stay, 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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직/간접 의료비 및 병원 외 경제적 비용
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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Pain scores
기간: Up to 1 week
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Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)
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Up to 1 week
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Morbidity and 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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Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
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Up to 1 month
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Systemic cytokine responses
기간: Up to 1 week
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Blood levels of IL-1β, IL-6, and C-reactive protein
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Up to 1 week
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Lymphocyte subsets
기간: Up to 1 week
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Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
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Up to 1 week
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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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