search
Back to results

Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Single incision plus one port laparoscopic surgery
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, ERAS, Single Incision plus one, Laparoscopic surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SILS plus one assistant ERAS

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Rehabilitative rate
    The percentage of patients who met discharge criteria in the fourth day after surgery
    Postoperative hospital stays
    Days from surgery to discharge

    Secondary Outcome Measures

    Medical cost
    The patient's expenses from surgery to discharge are recorded in RMB "yuan"
    Postoperative pain score
    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.
    Postoperative recovery index
    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
    Postoperative inflammatory immune response
    It includes the number of white blood cells and lymphocytes,CRP, IL-6
    compliance with ERAS measures
    It is defined as if the patients complete every ERAS measure or not. We can defined it "yes " or "not".
    6 min postoperative walking test(6MWT)
    Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002.
    hospital readmissions
    It can be defined as the number of patients readmitted within 30 days because of postoperative complications.
    Morbidity and mortality rates
    Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.

    Full Information

    First Posted
    December 25, 2019
    Last Updated
    February 12, 2020
    Sponsor
    Nanfang Hospital, Southern Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04268290
    Brief Title
    Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer
    Official Title
    Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2020 (Anticipated)
    Primary Completion Date
    February 15, 2022 (Anticipated)
    Study Completion Date
    February 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanfang Hospital, Southern Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Colorectal Cancer, ERAS, Single Incision plus one, Laparoscopic surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SILS plus one assistant ERAS
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Single incision plus one port laparoscopic surgery
    Other Intervention Name(s)
    The program of enhanced recovery After Surgery
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rehabilitative rate
    Description
    The percentage of patients who met discharge criteria in the fourth day after surgery
    Time Frame
    4 days
    Title
    Postoperative hospital stays
    Description
    Days from surgery to discharge
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Medical cost
    Description
    The patient's expenses from surgery to discharge are recorded in RMB "yuan"
    Time Frame
    1 month
    Title
    Postoperative pain score
    Description
    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.
    Time Frame
    Once a day from 6 hours to the fourth day after surgery
    Title
    Postoperative recovery index
    Description
    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
    Time Frame
    1 month
    Title
    Postoperative inflammatory immune response
    Description
    It includes the number of white blood cells and lymphocytes,CRP, IL-6
    Time Frame
    3 days
    Title
    compliance with ERAS measures
    Description
    It is defined as if the patients complete every ERAS measure or not. We can defined it "yes " or "not".
    Time Frame
    perioperative
    Title
    6 min postoperative walking test(6MWT)
    Description
    Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002.
    Time Frame
    Once a day from the frist to the fourth day after surgery
    Title
    hospital readmissions
    Description
    It can be defined as the number of patients readmitted within 30 days because of postoperative complications.
    Time Frame
    30days
    Title
    Morbidity and mortality rates
    Description
    Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wang Yanan, M.D
    Phone
    +86-131-8909-6629
    Email
    wyn8116@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang Yannan, M.D
    Organizational Affiliation
    Nanfang Hospital, Southern Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35116390
    Citation
    Zhang X, Li G, Li X, Liang Z, Lan X, Mou T, Xu Z, Fu J, Wu M, Li G, Wang Y. Effect of single-incision plus one port laparoscopic surgery assisted with enhanced recovery after surgery on colorectal cancer: study protocol for a single-arm trial. Transl Cancer Res. 2021 Dec;10(12):5443-5453. doi: 10.21037/tcr-21-1361.
    Results Reference
    derived

    Learn more about this trial

    Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer

    We'll reach out to this number within 24 hrs