Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
Recruiting now · Not applicable
Conditions studied: Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak, Quality of Life
In brief
The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. 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.
Key facts
- Study ID
- NCT05943444
- Run by
- Sixth Affiliated Hospital, Sun Yat-sen University
- People needed
- 256
- Starts
- 2023-08-08
- Expected to finish
- 2027-08-08
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women, aged between 18 and 75 years;
- 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;
- No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
- Suitable for anal preservation surgery discussed by MDT;
- Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
- R0 resection is expected technically;
- Provision of written informed consent.
You may not qualify if…
- Previous history of malignant colorectal tumors;
- Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
- Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
- Multiple primary tumors;
- History of other malignancy;
- Participation in other clinical trials within the previous 4 weeks of enrollment;
- ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
- Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
- History of serious mental disorders;
- Women in pregnancy or lactation period;
- Uncontrolled infection before operation;
- Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.
Where it is running
- The Sixth Affiliated Hospital, Sun Yatsen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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