PR in Endoscopic LAR for Rectal Cancer

Not Applicable

• Conditions: Rectal Carcinoma
• Interventions: Procedure: Pelvic floor Reconstruction

• Registration Number: NCT04078828
• Lead Sponsor: Southwest Hospital, China

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-31
• Study Start: 2019-09-01
• Study First Posted: 2019-09-06
• Primary Completion: 2020-08-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-28
• Last Update Posted: 2021-11-30
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-PR	Pelvic floor Reconstruction	-
PR	Pelvic floor Reconstruction	-

Primary Outcome Measures

Name	Time	Method
The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer	30 days after surgery
Re-operation rate after anastomotic leakage	30 days after surgery
The rate of general complications	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
3-year local recurrence rate	From date of operation until the date of local-recurrence (up to 3 years)
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample	5 days after surgery
Operative time	Operation day
Postoperative hospital stay	1 year after surgery
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
Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire	1 year after operation
Incidence of defecation dysfunction	From the date of operation until the date of complication,assessed up to 3 years
Blood loss	Operation day

Trial Locations

Locations (1)

General Surgery Center of PLA; 🇨🇳 Chongqing, Chongqing, China