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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak, Quality of Life

Intervention / Treatment
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* Procedure: Parks technique
* Procedure: Bacon technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, aged between 18 and 75 years; 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; No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation; Suitable for anal preservation surgery discussed by MDT; Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia; R0 resection is expected technically; Provision of written informed consent. Exclusion Criteria: Previous history of malignant colorectal tumors; Complications such as obstruction and gastrointestinal bleeding that need an emergency operation; Unachievable R0 resection due to invasion of adjacent organs by primary tumor; Multiple primary tumors; History of other malignancy; Participation in other clinical trials within the previous 4 weeks of enrollment; ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2; Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases; History of serious mental disorders; Women in pregnancy or lactation period; Uncontrolled infection before operation; Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal function, Parks technique, Bacon technique