Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum

Not Applicable

• Conditions: Rectal Carcinoma
• Interventions: Procedure: laparoscopic-assisted rectal resection; Procedure: conventional open rectal resection

• Registration Number: NCT01899547
• Lead Sponsor: Fujian Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-15
• Study Start: 2013-11-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-10-01
• Primary Completion: 2021-12-31
• Study Completion: 2023-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1070

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	laparoscopic-assisted rectal resection	Patients undergo laparoscopic-assisted rectal resection.
Arm II	conventional open rectal resection	Patients undergo conventional open rectal resection.

Primary Outcome Measures

Name	Time	Method
3 years disease-free survival	3 years	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) .

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 and 5 years post operatively	Overall survival is defined as the time from date of surgery to date of death from any cause.
Pathologic outcomes	1 week post operatively	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.
Locoregional recurrence rate	3 and 5 years post operatively	Locoregional recurrence was defined as the presence of any anastomotic, pelvic or perineal tumour documented by clinical and/or pathological examination.
30-day postoperative complications	1 month within operatively	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.
30-day postoperative mortality	30 days post operatively	Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 postoperative days.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China