Comparing two surgical techniques for anal function after low rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the postoperative anal function of patients with ultra-low rectal cancer who undergo either the Parks operation or the Bacon operation. Participants will be assessed for anal function and quality of life one year after surgery, with primary outcomes focusing on the Low Anterior Resection Syndrome (LARS) score. Secondary outcomes will include LARS scores at 3 and 6 months post-surgery, overall quality of life scores, and the incidence of postoperative complications. The goal is to provide clinical evidence that may improve surgical approaches and patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Sixth Affiliated Hospital, Sun Yatsen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jun Huang, MD — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Jun Huang, MD
• Email: huangj97@mail.sysu.edu.cn
• Phone: 13926451242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.