PR in Endoscopic LAR for Rectal Cancer

Southwest Hospital, China10 enrolled

Overview

The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.

Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR). We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Carcinoma

Interventions

Pelvic floor ReconstructionPROCEDURE

Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. patients with histologically proven rectal adenocarcinoma 2. tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection 3. Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI 4. Negative circumferential resection margin confirmed by MRI 5. Performance status (ECOG) 0\~1 6. Written informed consent for participation in the trial Exclusion Criteria: 1. History of accepting lower abdominal surgery. 2. More than one colorectal tumor 3. Patients with unresectable distant metastasis or multiple metastases 4. Received neoadjuvant radiotherapy before surgery 5. Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery 6. Patients and/or family members cannot understand and accept this study 7. Non-rectal adenocarcinoma was confirmed by postoperative pathological examination

Locations (1)

General Surgery Center of PLA

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer

Time frame: 30 days after surgery

Re-operation rate after anastomotic leakage

Time frame: 30 days after surgery

The rate of general complications

Time frame: 30 days after surgery

Secondary Outcomes

Operative time

Time frame: Operation day

Postoperative hospital stay

Time frame: 1 year after surgery

Incidence of defecation dysfunction

Time frame: From the date of operation until the date of complication,assessed up to 3 years

3-year local recurrence rate

Time frame: From date of operation until the date of local-recurrence (up to 3 years)

5-year disease-free survival

Time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire

Time frame: 1 year after operation

Blood loss

Time frame: Operation day

White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample

Central Contacts

Tang Bo, MD

CONTACT

+862368754167 tangtbo@sina.com

Li Chuan, MD

CONTACT

+862368754167 79168391@qq.com

Data from ClinicalTrials.gov

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