Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00726622|
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : November 11, 2016
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: Open laparotomy and rectal resection Procedure: Laparoscopic-assisted rectal resection||Phase 3|
This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below.
To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation.
To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs.
open rectal resection (blood loss, length of stay, pain medicine utilization)
- To assess disease free survival and local pelvic recurrence at two years.
- To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial.
Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures ≤ 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||486 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer|
|Actual Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||August 1, 2019|
Active Comparator: 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.
Procedure: Open laparotomy and rectal resection
Patients undergo open laparotomy and rectal resection.
Experimental: 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.
Procedure: Laparoscopic-assisted rectal resection
Patients undergo laparoscopic-assisted rectal resection.
- Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation. [ Time Frame: At time of Surgery ]
The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.
Primary endpoint parameters:
- Circumferential margin > 1 mm
- Negative distal margin
- Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.
All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.
- Completeness of Total Mesorectal Excision (Complete or Nearly Complete) [ Time Frame: At time of surgery ]
Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.
The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI.
- Negative Distal Resected Margin [ Time Frame: At time of surgery ]The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.
- Circumferential Margin > 1 mm [ Time Frame: At time of surgery ]The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.
- Length of Stay [ Time Frame: Two weeks post-surgery ]The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.
- Use of Pain Medication [ Time Frame: Two weeks post-surgery ]The number of days patients received parenteral narcotics post-surgery were counted.
- Operative Times [ Time Frame: During surgery ]Open to close operative time.
- Disease-free Survival [ Time Frame: Up to 2 years post surgery ]
- Local Pelvic Recurrence Rates [ Time Frame: Up to 2 years post surgery ]
- Overall Survival [ Time Frame: Up to 5 years post surgery ]
- Quality of Life and Sexual Function [ Time Frame: Up to 5 years post surgery ]
- Bowel Function [ Time Frame: Up to 5 years post surgery ]
- Bowel and Stoma Function [ Time Frame: Up to 5 years post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726622
|Study Chair:||James W. Fleshman, MD||Baylor Health|