To hear about similar clinical trials, please enter your email below
Trial Title:
Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
NCT ID:
NCT05943444
Condition:
Rectal Neoplasms
Low Anterior Resection Syndrome
Anastomotic Leak
Quality of Life
Conditions: Official terms:
Rectal Neoplasms
Low Anterior Resection Syndrome
Anastomotic Leak
Conditions: Keywords:
anal function
Parks technique
Bacon technique
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Parks technique
Description:
compare different operational styles of low rectal cancer
Arm group label:
Parks technique
Intervention type:
Procedure
Intervention name:
Bacon technique
Description:
Bacon technique
Arm group label:
Bacon technique
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sixth Affiliated Hospital, Sun Yatsen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Huang
Phone:
13926451242
Email:
huangj97@mail.sysu.edu.cn
Start date:
August 8, 2023
Completion date:
August 8, 2027
Lead sponsor:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Source:
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943444
