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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
Kontakty a umístění
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative hospital stays
Časové okno: 1 month
|
Days from surgery to discharge
|
1 month
|
|
Rehabilitative rate
Časové okno: 4 days
|
The percentage of patients who met discharge criteria in the fourth day after surgery
|
4 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Medical cost
Časové okno: 1 month
|
The patient's expenses from surgery to discharge are recorded in RMB "yuan"
|
1 month
|
|
Postoperative pain score
Časové okno: 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
Časové okno: 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
Časové okno: 3 days
|
It includes the number of white blood cells and lymphocytes,CRP, IL-6
|
3 days
|
|
compliance with ERAS measures
Časové okno: 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)
Časové okno: 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
Časové okno: 30days
|
It can be defined as the number of patients readmitted within 30 days because of postoperative complications.
|
30days
|
|
Morbidity and mortality rates
Časové okno: 30 days
|
Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.
|
30 days
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Wang Yannan, M.D, Nanfang Hospital of Southern Medical University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NFEC-2019-156
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .