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Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00726622
First received: July 31, 2008
Last updated: September 23, 2016
Last verified: August 2016
Results First Received: August 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Procedure: Open laparotomy and rectal resection
Procedure: Laparoscopic-assisted rectal resection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Open Laparotomy and Rectal Resection Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
Arm 2: Laparoscopic-assisted Rectal Resection Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Participant Flow:   Overall Study
    Arm 1: Open Laparotomy and Rectal Resection   Arm 2: Laparoscopic-assisted Rectal Resection
STARTED   243   243 
COMPLETED   225   240 
NOT COMPLETED   18   3 
Withdrawal by Subject                16                2 
Physician Decision                0                1 
Metastasis                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients that were randomized to a treatment arm were available for baseline characteristics. Four patients from Arm 1: Open laparotomy and rectal resection and one patient from Arm 2: Laparoscopic-assisted rectal resection are not shown because of patient refusal or improper consent.

Reporting Groups
  Description
Arm 1: Open Laparotomy and Rectal Resection Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
Arm 2: Laparoscopic-assisted Rectal Resection Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
Total Total of all reporting groups

Baseline Measures
   Arm 1: Open Laparotomy and Rectal Resection   Arm 2: Laparoscopic-assisted Rectal Resection   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   242   481 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.2  (12.1)   57.7  (11.5)   57.4  (11.8) 
Gender 
[Units: Participants]
     
Female   81   86   167 
Male   158   156   314 
Region of Enrollment 
[Units: Participants]
     
United States   239   242   481 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Non-Inferiority Analysis Between Laparoscopic-assisted Resection and Open Rectal Resection for Rectal Cancer.   [ Time Frame: At time of Surgery ]

2.  Secondary:   Completeness of Total Mesorectal Excision (Complete or Nearly Complete)   [ Time Frame: At time of surgery ]

3.  Secondary:   Negative Distal Resected Margin   [ Time Frame: At time of surgery ]

4.  Secondary:   Circumferential Margin > 1 mm   [ Time Frame: At time of surgery ]

5.  Secondary:   Length of Stay   [ Time Frame: Up to 5 years post surgery ]

6.  Secondary:   Use of Pain Medication   [ Time Frame: Up to 5 years post surgery ]

7.  Secondary:   Operative Times   [ Time Frame: During surgery ]

8.  Secondary:   Disease-free Survival   [ Time Frame: Up to 2 years post surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Local Pelvic Recurrence Rates   [ Time Frame: Up to 2 years post surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years post surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Quality of Life and Sexual Function   [ Time Frame: Up to 5 years post surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Bowel Function   [ Time Frame: Up to 5 years post surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Bowel and Stoma Function   [ Time Frame: Up to 5 years post surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tonia M. Young-Fadok, M.D.
Organization: Mayo Clinic
e-mail: youngfadok.tonia@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00726622     History of Changes
Other Study ID Numbers: ACOSOG-Z6051
U10CA076001 ( US NIH Grant/Contract Award Number )
NCI-2009-00350 ( Other Identifier: NCI Clinical Trial Reporting Office )
CDR0000601816 ( Registry Identifier: NCI Physician Data Query )
Study First Received: July 31, 2008
Results First Received: August 11, 2016
Last Updated: September 23, 2016
Health Authority: United States: NCI Central Institutional Review Board