Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.

Official Title
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Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial

Conditions
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Rectal Carcinoma

Intervention / Treatment
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* Procedure: laparoscopic-assisted rectal resection
* Procedure: conventional open rectal resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven rectal adenocarcinoma inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy no evidence of distant metastases tumor size <6cm sufficient organ function no contraindication to laparoscopic surgery without other malignancies in medical history Exclusion Criteria: concurrent or previous diagnosis of invasive cancer within 5 years locally advanced cancers requiring en bloc multivisceral resection intestinal obstruction intestinal perforation history of colorectal surgery American Society of Anesthesiologists(ASA) class 4 or 5 pregnant or breast-feeding women history of mental disorder participation in another rectal cancer clinical trial relating to surgical technique

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo laparoscopic-assisted rectal resection. | Procedure: laparoscopic-assisted rectal resection<br>* Arm I: Patients undergo laparoscopic-assisted rectal resection.<br>|
| Active Comparator: Arm II<br>Patients undergo conventional open rectal resection. | Procedure: conventional open rectal resection<br>* Arm II: Patients undergo conventional open rectal resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 years disease-free survival | Disease-free survival is defined as the time from date of surgery to the date of rectal cancer recurrence or metastasis or cancer-related death (locoregional or distant recurrence) . | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic outcomes | Pathologic outcomes are defined as TME quality, negative CRM and negative DRM, length of proximal resection margin (PRM), length of DRM, and the number of retrieved lymph nodes.The TME quality was graded based on the criteria proposed by Nagtegaal et al. as complete, nearly complete, or incomplete.Positive resection margin, including circumferential resection margin (CRM) and distal resection margin (DRM), was defined as the presence of cancer cells within 1 mm from the cut edge. | 1 week post operatively | 
| 30-day postoperative complications | Thirty-day postoperative complications included any complications occurring within 30 days after surgery. Postoperative complications were graded according to the Clavien-Dindo classification. Severe complications were defined as Clavien-Dindo III-V. | 1 month within operatively | 
| 30-day postoperative mortality | Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 postoperative days. | 30 days post operatively | 
| Overall survival | Overall survival is defined as the time from date of surgery to date of death from any cause. | 3 and 5 years post operatively | 
| Locoregional recurrence rate | Locoregional recurrence was defined as the presence of any anastomotic, pelvic or perineal tumour documented by clinical and/or pathological examination. | 3 and 5 years post operatively |