PR in Endoscopic LAR for Rectal Cancer

Sponsor
Southwest Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04078828
Collaborator
(none)
10
1
2
31
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pelvic floor Reconstruction
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer [30 days after surgery]

  2. Re-operation rate after anastomotic leakage [30 days after surgery]

  3. The rate of general complications [30 days after surgery]

Secondary Outcome Measures

  1. Operative time [Operation day]

  2. Postoperative hospital stay [1 year after surgery]

  3. Incidence of defecation dysfunction [From the date of operation until the date of complication,assessed up to 3 years]

  4. 3-year local recurrence rate [From date of operation until the date of local-recurrence (up to 3 years)]

  5. 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]

  6. Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire [1 year after operation]

  7. Blood loss [Operation day]

  8. White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample [1 days after surgery]

  9. White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample [3 days after surgery]

  10. White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample [5 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Surgery Center of PLA Chongqing Chongqing China 400038

Sponsors and Collaborators

  • Southwest Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Li Chuan, Secretary of General Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT04078828
Other Study ID Numbers:
  • PRLAR-SURGERY
First Posted:
Sep 6, 2019
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Li Chuan, Secretary of General Surgery, Southwest Hospital, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2021