Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
Recruiting · NCT05943444 · Interventional (participants receive a specific treatment) · Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- The Sixth Affiliated Hospital, Sun Yatsen University - Guangzhou, Guangdong, China