Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Low Anterior Resection Syndrome; Rectal Neoplasms; Anastomotic Leak
• Intervention / Treatment: Procedure: Parks technique; Procedure: Bacon technique

Detailed Description

objective: 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.

primary outcome: Low Anterior Resection Syndrome (LARS) score 1 year after surgery secondary outcomes: 1. LARS score at 3 months after surgery 2. LARS score at 6 months after surgery 3. Postoperative Quality of Life Score 4. The incidence of postoperative anastomotic complications

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Huang, MD; Phone Number: 13926451242; Email: huangj97@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yatsen University
      • Contact: Jun Huang; Phone Number: 13926451242; Email: huangj97@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parks technique; patients receive coloanal anastomosis operation	Procedure: Parks technique; compare different operational styles of low rectal cancer
Experimental: Bacon technique; patients receive coloanal pull-out anastomosis operation	Procedure: Bacon technique; Bacon technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Anterior Resection Syndrome (LARS) score 1 year after surgery	use a scoring system for bowel dysfunction after LAR for rectal cancer on the basis of symptoms and impact on quality of life	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS score at 3 months after surgery	to score bowel dysfunction after LAR	3 months after surgery
LARS score at 6 months after surgery	to score bowel dysfunction after LAR	6 months after surgery
Postoperative Quality of Life Score	using a score system to access the quality of life after surgery	3, 6, and 12 months after operation
The incidence of postoperative anastomotic complications	the corresponding complications after surgery	3, 6, and 12 months after operation

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Jun Huang, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): August 8, 2027
• Study Completion (Estimated): August 8, 2027

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anal function; Parks technique; Bacon technique
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Low Anterior Resection Syndrome; Rectal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: E2023072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No