PR in Endoscopic LAR for Rectal Cancer

NCT ID: NCT04078828

Last Updated: 2021-11-30

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Carcinoma

Keywords

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minimally invasive surgical

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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PR

Group Type ACTIVE_COMPARATOR

Pelvic floor Reconstruction

Intervention Type PROCEDURE

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

Non-PR

Group Type ACTIVE_COMPARATOR

Pelvic floor Reconstruction

Intervention Type PROCEDURE

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

Interventions

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Pelvic floor Reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Li Chuan

Secretary of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Surgery Center of PLA

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tang Bo, MD

Role: CONTACT

Phone: +862368754167

Email: [email protected]

Li Chuan, MD

Role: CONTACT

Phone: +862368754167

Email: [email protected]

Facility Contacts

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Tang Bo, M.D/Ph.D

Role: primary

Other Identifiers

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PRLAR-SURGERY

Identifier Type: -

Identifier Source: org_study_id