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

Not Applicable

Recruiting

• Conditions: Low Anterior Resection Syndrome; Anastomotic Leak; Rectal Neoplasms; Quality of Life
• Interventions: Procedure: Bacon technique; Procedure: Parks technique

• Registration Number: NCT05943444
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

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 Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-13
• Study Start: 2023-08-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-07
• Primary Completion: 2027-08-08
• Study Completion: 2027-08-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacon technique	Bacon technique	patients receive coloanal pull-out anastomosis operation
Parks technique	Parks technique	patients receive coloanal anastomosis operation

Primary Outcome Measures

Name	Time	Method
Low Anterior Resection Syndrome (LARS) score 1 year after surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yatsen University; 🇨🇳 Guangzhou, Guangdong, China