Phase 3
N=486
Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00726622 ↗Enrolled (actual)
486
Serious AEs
4.4%
Results posted
Nov 2016
Primary outcome: Primary: 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. — 86.9; 81.7 percentage of participants — p=0.41
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Open laparotomy and rectal resection (Procedure); Laparoscopic-assisted rectal resection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
86.9; 81.7 | 0.41 |
| SECONDARY Completeness of Total Mesorectal Excision (Complete or Nearly Complete) |
95.1; 92.1 | — |
| SECONDARY Negative Distal Resected Margin |
98.2; 98.3 | — |
| SECONDARY Circumferential Margin > 1 mm |
92.3; 87.9 | — |
| SECONDARY Length of Stay |
7.0; 7.3 | — |
| SECONDARY Use of Pain Medication |
4.2; 4.2 | — |
| SECONDARY Operative Times |
220.6; 266.2 | — |
| SECONDARY Disease-free Survival |
— | — |
| SECONDARY Local Pelvic Recurrence Rates |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Quality of Life and Sexual Function |
— | — |
| SECONDARY Bowel Function |
— | — |
| SECONDARY Bowel and Stoma Function |
— | — |
Summary
This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.
Eligibility Criteria
Eligibility Criteria:
- Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge)
- T3, N0, M0, T1-3, N1-2, M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible.
- Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
- Age ≥ 18 years
- ECOG (Zubrod) Performance Status ≤ 2
- Body Mass Index (BMI) ≤ 34
- No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)
- No systemic disease (cardiovascular, renal, hepatic) that would preclude surgery. No other severe incapacitating disease:
- ASA IV: A patient with severe systemic disease that is a constant threat to life. OR
- ASA V: A moribund patient who is not expected to survive without the operation.
- No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration
- No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
NOTE: Incompetent patients are not eligible for this trial.
Data sourced from ClinicalTrials.gov (NCT00726622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.