PR in Endoscopic LAR for Rectal Cancer

Rectal Carcinoma Clinical Trial

Official title:

Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04078828
• Other study ID #: PRLAR-SURGERY
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2021
• Source: Southwest Hospital, China
• Contact: Tang Bo, MD
• Phone: +862368754167
• Email: tangtbo[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2022
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Carcinoma
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	General Surgery Center of PLA	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer		30 days after surgery
Primary	Re-operation rate after anastomotic leakage		30 days after surgery
Primary	The rate of general complications		30 days after surgery
Secondary	Operative time		Operation day
Secondary	Postoperative hospital stay		1 year after surgery
Secondary	Incidence of defecation dysfunction		From the date of operation until the date of complication,assessed up to 3 years
Secondary	3-year local recurrence rate		From date of operation until the date of local-recurrence (up to 3 years)
Secondary	5-year disease-free survival		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
Secondary	Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire		1 year after operation
Secondary	Blood loss		Operation day
Secondary	White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample		1 days after surgery
Secondary	White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample		3 days after surgery
Secondary	White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample		5 days after surgery