Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer
Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial
Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. To achieve further minimally invasive outcomes, SILS plus one port surgery was attempted by some surgeons. Preliminary results showed that SILS+1 could achieve better minimally invasive benefits than CLS while preserving oncologic feasibility.
Till now, ERAS has been practiced in colorectal cancer surgery for approximately 20 years. Studies have proven that ERAS is safe and significantly improved the recovery course of patients during perioperative period, meanwhile, the expense could be greatly reduced.
Based on ERAS studies protocols and SILS+1 trials, investigators tried to combine SILS+1 with ERAS, hopefully to provide patients with more safe, economic, feasible and rapid surgery and perioperative strategies.
연구 개요
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Primary tumor diagnosed as adenocarcinoma confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, the upper segment of the rectum.
- Diameter ≦ 5cm
- No severe organ dysfunction
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I or II
- Written informed consent
Exclusion Criteria:
- Unsuitable for patients undergoing single incision plus one port laparoscopic surgery
- Patients with Complications caused by colorectal cancer ( bleeding , perforation, obstruction or incomplete obstruction )
- Previous abdominal surgery
- Malignant diseases within the past 5years
- Requirements of simultaneous surgery for another diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: SILS plus one assistant ERAS
Preoperative: preadmission information, education, counseling, optimization ( breathing training), shortening fasting time and carbohydrate load Intraoperative: The intravenous fluid therapy is restricted. All patients undergo single incision plus one port laparoscopic surgery(SILS plus one). A suitable warming device (such as forced-air heating blankets) and warmed intravenous fluids are been adopted routinely to keep body temperature Postoperative: multimodal analgesia (surgical site infiltration, a nonsteroidal anti-inflammatory drug, epidural analgesia) early oral intake and move. nasogastric tubes should not be used routinely. Nasogastric tubes inserted during surgery are been removed before reversal of an aesthesia. |
SILS plus one port surgery and enhanced recovery after surgery protocol both are methods taking the minimally invasive benefits for the patients including faster recovery, reduced postoperative pain and shorter hospital stay.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative hospital stays
기간: 1 month
|
Days from surgery to discharge
|
1 month
|
|
Rehabilitative rate
기간: 4 days
|
The percentage of patients who met discharge criteria in the fourth day after surgery
|
4 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medical cost
기간: 1 month
|
The patient's expenses from surgery to discharge are recorded in RMB "yuan"
|
1 month
|
|
Postoperative pain score
기간: Once a day from 6 hours to the fourth day after surgery
|
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day .
On a scale of 1 to 10, the higher the score, the greater the pain.
|
Once a day from 6 hours to the fourth day after surgery
|
|
Postoperative recovery index
기간: 1 month
|
The first Time to early mobilization(hour), flatus(hour), liquid diet(hour), soft diet(hour), removal of the Nasogastric tubes(hour) , removal of the peritoneal drainage(hour) are used to assess the postoperative recovery
|
1 month
|
|
Postoperative inflammatory immune response
기간: 3 days
|
It includes the number of white blood cells and lymphocytes,CRP, IL-6
|
3 days
|
|
compliance with ERAS measures
기간: perioperative
|
It is defined as if the patients complete every ERAS measure or not.
We can defined it "yes " or "not".
|
perioperative
|
|
6 min postoperative walking test(6MWT)
기간: Once a day from the frist to the fourth day after surgery
|
Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002.
|
Once a day from the frist to the fourth day after surgery
|
|
hospital readmissions
기간: 30days
|
It can be defined as the number of patients readmitted within 30 days because of postoperative complications.
|
30days
|
|
Morbidity and mortality rates
기간: 30 days
|
Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.
|
30 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Wang Yannan, M.D, Nanfang Hospital of Southern Medical University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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