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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05943444

Collaborator

(none)

256

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms Low Anterior Resection Syndrome Anastomotic Leak Quality of Life	Procedure: Parks technique Procedure: Bacon technique	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Aug 8, 2023

Anticipated Primary Completion Date :

Aug 8, 2027

Anticipated Study Completion Date :

Aug 8, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.