Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum

Fujian Medical University1,070 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,070

Conditions

Rectal Carcinoma

Interventions

laparoscopic-assisted rectal resectionPROCEDURE

Arm I: Patients undergo laparoscopic-assisted rectal resection.

conventional open rectal resectionPROCEDURE

Arm II: Patients undergo conventional open rectal resection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

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) .

Time frame: 3 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 30 days post operatively

Overall survival

Overall survival is defined as the time from date of surgery to date of death from any cause.

Time frame: 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.

Data from ClinicalTrials.gov

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