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

Primary Purpose

Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parks technique
Bacon technique
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Neoplasms focused on measuring anal function, Parks technique, Bacon technique

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Parks technique

    Bacon technique

    Arm Description

    patients receive coloanal anastomosis operation

    patients receive coloanal pull-out anastomosis operation

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05943444
    Brief Title
    Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 8, 2023 (Anticipated)
    Primary Completion Date
    August 8, 2027 (Anticipated)
    Study Completion Date
    August 8, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak, Quality of Life
    Keywords
    anal function, Parks technique, Bacon technique

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    256 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Parks technique
    Arm Type
    Active Comparator
    Arm Description
    patients receive coloanal anastomosis operation
    Arm Title
    Bacon technique
    Arm Type
    Experimental
    Arm Description
    patients receive coloanal pull-out anastomosis operation
    Intervention Type
    Procedure
    Intervention Name(s)
    Parks technique
    Intervention Description
    compare different operational styles of low rectal cancer
    Intervention Type
    Procedure
    Intervention Name(s)
    Bacon technique
    Intervention Description
    Bacon technique
    Primary Outcome Measure Information:
    Title
    Low Anterior Resection Syndrome (LARS) score 1 year after surgery
    Description
    use a scoring system for bowel dysfunction after LAR for rectal cancer on the basis of symptoms and impact on quality of life
    Time Frame
    1 year after surgery
    Secondary Outcome Measure Information:
    Title
    LARS score at 3 months after surgery
    Description
    to score bowel dysfunction after LAR
    Time Frame
    3 months after surgery
    Title
    LARS score at 6 months after surgery
    Description
    to score bowel dysfunction after LAR
    Time Frame
    6 months after surgery
    Title
    Postoperative Quality of Life Score
    Description
    using a score system to access the quality of life after surgery
    Time Frame
    3, 6, and 12 months after operation
    Title
    The incidence of postoperative anastomotic complications
    Description
    the corresponding complications after surgery
    Time Frame
    3, 6, and 12 months after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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

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