NCT04078828

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

August 15, 2019

Last Update Submit

November 28, 2021

Conditions

Rectal Carcinoma

Keywords

minimally invasive surgical

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Operative time

    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

  • +5 more secondary outcomes

Study Arms (2)

PR

ACTIVE COMPARATOR
Procedure: Pelvic floor Reconstruction

Non-PR

ACTIVE COMPARATOR
Procedure: Pelvic floor Reconstruction

Interventions

Pelvic floor ReconstructionPROCEDURE

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

Non-PRPR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with histologically proven rectal adenocarcinoma
  • tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
  • Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
  • Negative circumferential resection margin confirmed by MRI
  • Performance status (ECOG) 0\~1
  • Written informed consent for participation in the trial

You may not qualify if:

  • History of accepting lower abdominal surgery.
  • More than one colorectal tumor
  • Patients with unresectable distant metastasis or multiple metastases
  • Received neoadjuvant radiotherapy before surgery
  • Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
  • Patients and/or family members cannot understand and accept this study
  • Non-rectal adenocarcinoma was confirmed by postoperative pathological examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery Center of PLA

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Tang Bo, MD

CONTACT

+862368754167tangtbo@sina.com

Li Chuan, MD

CONTACT

+86236875416779168391@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Secretary of General Surgery

Study Record Dates

First Submitted

August 15, 2019

First Posted

September 6, 2019

Study Start

September 1, 2019

Primary Completion

August 1, 2020

Study Completion

April 1, 2022

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

CN(1)