Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
NCT ID: NCT03431428
Last Updated: 2018-02-13
Study Results
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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UNKNOWN
PHASE3
477 participants
INTERVENTIONAL
2018-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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transanal surgery
To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm.
The intestinal wall was sutured to ensure the integrity of the bowel.
transanal surgery
Transanal surgery could Preserve anus to reduce trauma and improve the quality of life
Preoperative chemoradiotherapy
After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
Miles surgery
According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.
Miles surgery
Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.
Preoperative chemoradiotherapy
After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
Interventions
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transanal surgery
Transanal surgery could Preserve anus to reduce trauma and improve the quality of life
Miles surgery
Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.
Preoperative chemoradiotherapy
After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
Eligibility Criteria
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Inclusion Criteria
2. 18 to 75 years old.
3. Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
4. The anus couldn't be retained after TME.
5. Almost-cCR or cCR recurrence during observation.
Exclusion Criteria
2. Preoperative stage: T4b or progress during the treatment.
3. HIV infection stage or chronic hepatitis B.
4. Active clinical severe infections.
5. Evil liquid state or decompensation of organ function.
6. Other malignant tumor history in five years.
7. Other primary carcinoma.
8. Unstable condition and incompliance of the patient
18 Years
75 Years
ALL
No
Sponsors
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Zhang Rui
OTHER
Responsible Party
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Zhang Rui
Head of colorectal surgery,clinical professor
Principal Investigators
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peirong ding, doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
ji zhu, doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
zhenning wang, doctor
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
hong zhang, doctor
Role: PRINCIPAL_INVESTIGATOR
Shengjing Hospital
yu han, doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Harbin Medical University
zhaocheng chi, doctor
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Tumor Hospital
quan wang, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
ge liu, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
hang lu, doctor
Role: PRINCIPAL_INVESTIGATOR
Jinzhou Medical University
zheng liu, doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
rui Zhang, doctor
Role: STUDY_DIRECTOR
Liaoning Cancer Hospital & Institute
Locations
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Liaoning cancer Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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References
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Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.
Other Identifiers
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20171112
Identifier Type: -
Identifier Source: org_study_id
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