PR in Endoscopic LAR for Rectal Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Carcinoma
• Intervention / Treatment: Procedure: Pelvic floor Reconstruction

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tang Bo, MD; Phone Number: +862368754167; Email: tangtbo@sina.com
• Study Contact Backup: Name: Li Chuan, MD; Phone Number: +862368754167; Email: 79168391@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • General Surgery Center of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PR	Procedure: Pelvic floor Reconstruction; Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.
Active Comparator: Non-PR	Procedure: Pelvic floor Reconstruction; Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 31, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: minimally invasive surgical
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PRLAR-SURGERY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No