The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection

NCT ID: NCT03699761

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rectum Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pelvic Peritonization

Group Type EXPERIMENTAL

Closure of the pelvic peritoneum

Intervention Type PROCEDURE

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

Nonclosure of the pelvic peritoneum

Intervention Type PROCEDURE

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

Without Pelvic Peritonization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Closure of the pelvic peritoneum

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

Intervention Type PROCEDURE

Nonclosure of the pelvic peritoneum

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Tang Bo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Surgery Center of PLA

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tang Bo, MD

Role: CONTACT

+8613883902288

Li Chuan

Role: CONTACT

+86-18323479228

Facility Contacts

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Tang Bo, M.D/Ph.D

Role: primary

+862368754167

Other Identifiers

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POLAR

Identifier Type: -

Identifier Source: org_study_id

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