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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943444
• Other study ID #: E2023072
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: August 8, 2027

Study information

• Verified date: April 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jun Huang, MD
• Phone: 13926451242
• Email: huangj97[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: August 8, 2027
• Est. primary completion date: August 8, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Low Anterior Resection Syndrome
• Quality of Life
• Rectal Neoplasms

Intervention

Procedure:
• Parks technique
compare different operational styles of low rectal cancer
• Bacon technique
Bacon technique

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yatsen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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