NCT03699761

Brief Summary

A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.

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
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 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

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3.9 years

First QC Date

October 5, 2018

Last Update Submit

May 3, 2023

Conditions

Rectum Cancer

Keywords

Anastomotic leakageComplicationReoperationPelvic Peritonization

Outcome Measures

Primary Outcomes (1)

  • Grade III-IV complications

    The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection

    30 days

Secondary Outcomes (15)

  • Rate of reoperation

    30 days

  • Detection of inflammation markers

    7 days

  • The rate of anastomotic leakage

    30 days

  • Hospital time

    30 days

  • Overall complication rate

    30days

  • +10 more secondary outcomes

Study Arms (2)

Pelvic Peritonization

EXPERIMENTAL
Procedure: Closure of the pelvic peritoneumProcedure: Nonclosure of the pelvic peritoneum

Without Pelvic Peritonization

NO INTERVENTION

Interventions

Closure of the pelvic peritoneumPROCEDURE

Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.

Pelvic Peritonization
Nonclosure of the pelvic peritoneumPROCEDURE

Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.

Pelvic Peritonization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Matching the diagnostic criteria of rectal adenocarcinoma
  • Laparoscopic or robotic radical surgery for rectal cancer
  • Preoperative TNM staging T1-3N0-2M0
  • No history of malignant tumors by preoperative examination
  • Middle and low rectal cancer
  • Tumor size of 4 cm or less
  • ASA 1-3 scores
  • Written informed consent by the patient
  • The patient is willing to randomize to any group

You may not qualify if:

  • Previous abdominal surgery
  • Past malignant tumor history
  • Preoperative examination suggests distant metastasis
  • Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
  • Emergency operation
  • Elimination criteria
  • The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
  • The anastomosis is located above the peritoneum reflex
  • Intraoperative conversion to laparotomy
  • Change the surgical method to perform Miles or Hartmann surgery
  • Postoperative pathologically confirmed non-adenocarcinoma
  • The patient asked to withdraw

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery Center of PLA

Chongqing, 400038, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Tang Bo, MD

CONTACT

+8613883902288tangtbo@sina.cn

Li Chuan

CONTACT

+86-18323479228lee_tran@126.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
Principal Investigator

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

September 1, 2020

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

CN(1)