Actively Recruiting
Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer A Prospective, Multicentric and Randomized Controlled Study
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-12-18
256
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates patients with ultra-low rectal cancer to compare postoperative anal function following two surgical methods: the Parks operation (colon anal anastomosis) and the Bacon operation (colon anal pull-out anastomosis). The purpose is to provide clinical evidence on how these techniques affect anal function and quality of life after surgery. The study is randomized and prospective, focusing on the differences in anal function one year after surgery. Participants will be randomly assigned to receive either the Parks or Bacon surgical technique. Researchers will assess anal function using the Low Anterior Resection Syndrome (LARS) score at 3 months, 6 months, and 1 year after surgery. They will also monitor quality of life and the occurrence of postoperative complications related to the anastomosis over these time points. During the study, participants will undergo evaluations of their anal function and quality of life at several intervals up to one year after surgery. The main measurement is the LARS score at one year, with additional assessments at 3 and 6 months. Researchers will monitor any complications and overall patient well-being to better understand the impact of each surgical method. The total participation time aligns with these follow-ups.
CONDITIONS
Brief Title
Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged between 18 and 75 years
- Pathological diagnosis of rectal cancer with tumor within 3 cm of the dentate line by MRI
- No local complications such as obstruction, active bleeding, or invasion of sphincter muscles before surgery
- Suitable for anal preservation surgery as decided by a multidisciplinary team
- Adequate bone marrow, liver, kidney, and heart function for surgery and anesthesia
- Expected technically feasible R0 resection
- Provided written informed consent
You will not qualify if you...
- Previous history of malignant colorectal tumors
- Emergency surgery needed due to complications like obstruction or bleeding
- Invasion of adjacent organs preventing complete tumor removal (R0 resection)
- Multiple primary tumors
- History of other malignancies
- Participation in other clinical trials within 4 weeks before enrollment
- ASA physical status score of IV or higher and/or ECOG performance status of 2 or higher
- Intolerance to surgery due to liver, kidney, heart, lung, blood clotting problems, or other diseases
- History of serious mental disorders
- Women who are pregnant or breastfeeding
- Uncontrolled infection before surgery
- Other clinical or laboratory conditions making inclusion unsuitable per investigator judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo surgery using either the Parks or Bacon technique for low rectal cancer.
1 surgical procedure and hospital stay
Duration - 12 months
Participants are monitored for anal function, quality of life, and anastomotic complications after surgery.
Visits at 3, 6, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jun Huang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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