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

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ClinicalTrials.gov Identifier: NCT01969591
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Quan Wang, First Hospital of Jilin University

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date October 25, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Length of hospital stay [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  • Postoperative days [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  • First flatus time [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  • First defecation time [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  • solid diet time [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Analgesics [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  • CRP (mg/L) [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  • Complications:anastomotic leakage,intestinal obstruction,wound infection [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
Official Title  ICMJE Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Procedure: fast-track surgery
    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.
  • Other: conventional postoperative surgery
    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.
Study Arms  ICMJE
  • Experimental: fast-track surgery
    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: Procedure: fast-track surgery
  • convontional postoperative care
    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: Other: conventional postoperative surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2013)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969591
Other Study ID Numbers  ICMJE 2013-171
2013-171
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quan Wang, First Hospital of Jilin University
Study Sponsor  ICMJE Quan Wang
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Hospital of Jilin University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP