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Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery (FTS)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fast-track surgery
conventional postoperative surgery
Sponsored by
Quan Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Fast track surgery, Laparoscopic surgery, colorectal cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≤75 years
  • Good nutrition
  • no systemic infection
  • Elective laparoscopic surgery

Exclusion Criteria:

  • Age >75 years
  • Malnutrition or an organ system infection
  • Associated with obstruction, bleeding, emergency surgery or surgical intervention
  • Tumor with extensive metastasis
  • Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
  • Previous history of abdominal surgery
  • Patient had previously undergone gastrostomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    fast-track surgery

    convontional postoperative care

    Arm Description

    Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.

    Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.

    Outcomes

    Primary Outcome Measures

    Length of hospital stay
    Postoperative days
    First flatus time
    First defecation time
    solid diet time

    Secondary Outcome Measures

    Analgesics
    CRP (mg/L)
    Complications:anastomotic leakage,intestinal obstruction,wound infection

    Full Information

    First Posted
    October 8, 2013
    Last Updated
    October 21, 2013
    Sponsor
    Quan Wang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01969591
    Brief Title
    Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
    Acronym
    FTS
    Official Title
    Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Quan Wang

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.
    Detailed Description
    Method: This study is a blinded randomized trial. 70 patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Outcome measures, length of hospital stay, postoperative surgical stress response (C reactive protein) and postoperative complications will be compared between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Fast track surgery, Laparoscopic surgery, colorectal cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fast-track surgery
    Arm Type
    Experimental
    Arm Description
    Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
    Arm Title
    convontional postoperative care
    Arm Type
    Other
    Arm Description
    Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
    Intervention Type
    Procedure
    Intervention Name(s)
    fast-track surgery
    Intervention Description
    Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
    Intervention Type
    Other
    Intervention Name(s)
    conventional postoperative surgery
    Intervention Description
    Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
    Primary Outcome Measure Information:
    Title
    Length of hospital stay
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Title
    Postoperative days
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Title
    First flatus time
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Title
    First defecation time
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Title
    solid diet time
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Secondary Outcome Measure Information:
    Title
    Analgesics
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Title
    CRP (mg/L)
    Time Frame
    with the first 30 days(plus or minus 3days) after surgery
    Title
    Complications:anastomotic leakage,intestinal obstruction,wound infection
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≤75 years Good nutrition no systemic infection Elective laparoscopic surgery Exclusion Criteria: Age >75 years Malnutrition or an organ system infection Associated with obstruction, bleeding, emergency surgery or surgical intervention Tumor with extensive metastasis Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support Previous history of abdominal surgery Patient had previously undergone gastrostomy

    12. IPD Sharing Statement

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