Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
NCT ID: NCT05943444
Last Updated: 2025-12-18
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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RECRUITING
NA
256 participants
INTERVENTIONAL
2023-08-08
2027-08-08
Brief Summary
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The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.
Detailed Description
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primary outcome: Low Anterior Resection Syndrome (LARS) score 1 year after surgery secondary outcomes: 1. LARS score at 3 months after surgery 2. LARS score at 6 months after surgery 3. Postoperative Quality of Life Score 4. The incidence of postoperative anastomotic complications
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Parks technique
patients receive coloanal anastomosis operation
Parks technique
compare different operational styles of low rectal cancer
Bacon technique
patients receive coloanal pull-out anastomosis operation
Bacon technique
Bacon technique
Interventions
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Parks technique
compare different operational styles of low rectal cancer
Bacon technique
Bacon technique
Eligibility Criteria
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Inclusion Criteria
2. Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
3. No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
4. Suitable for anal preservation surgery discussed by MDT;
5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
6. R0 resection is expected technically;
7. Provision of written informed consent.
Exclusion Criteria
2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
4. Multiple primary tumors;
5. History of other malignancy;
6. Participation in other clinical trials within the previous 4 weeks of enrollment;
7. ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
9. History of serious mental disorders;
10. Women in pregnancy or lactation period;
11. Uncontrolled infection before operation;
12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.
18 Years
75 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Principal Investigators
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Jun Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jun Huang
Role: primary
Other Identifiers
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E2023072
Identifier Type: -
Identifier Source: org_study_id