NCT05943444 Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
| NCT ID | NCT05943444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Rectal Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2023-08-08 |
| Primary Completion | 2027-08-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2023-08-08 with a primary completion date of 2027-08-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Men or women, aged between 18 and 75 years; 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: 1. Previous history of malignant colorectal tumors; 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.
Contact & Investigator
Jun Huang, MD
PRINCIPAL INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT05943444 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05943444 currently recruiting?
Yes, NCT05943444 is actively recruiting participants. Contact the research team at huangj97@mail.sysu.edu.cn for enrollment information.
Where is the NCT05943444 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05943444 clinical trial?
NCT05943444 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The principal investigator is Jun Huang, MD at Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 256 participants.