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

Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study

This study is testing which of two surgical methods helps people with ultra-low rectal cancer have better bowel control and quality of life after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05943444 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 to 75 with a pathological diagnosis of rectal cancer and specific tumor characteristics suitable for anal preservation surgery.

Not a fit: Patients with previous colorectal malignancies or those requiring emergency operations due to complications will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved anal function and quality of life for patients undergoing surgery for low rectal cancer.

How similar studies have performed: While similar studies have explored surgical techniques for rectal cancer, this specific comparison of the Parks and Bacon techniques is novel.

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.

Where this trial is running

Guangzhou, Guangdong

• 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

Conditions: Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak, Quality of Life, anal function, Parks technique, Bacon technique