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Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial

Primary Purpose

Gastrointestinal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
openSide to end colorectal anastomosis .
open end end to end stapler anastomosis
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. colo rectum adenocarcinoma proved by biopsy and histo-pathological examination.

    2. Only resections performed with immediate anastomosis, not under cover of stoma.

    3. Expected R0 resection. 4. patients >18 years ,both sex 6. No previous history of stool or flatus incontinence, and clinically normal function of anal sphincter.

Exclusion Criteria:

  1. Patients younger than 18 years , Pregnant female.
  2. Inability to understand the informed consent or refuse to participate or psychiatric patients.
  3. Patients with recurrent cancer, Irresectable tumour, widespread loco-regional, distant metastasis ,Combination operation and Complicated cancer e.g. obstructed or perforated.
  4. Cases covered by proximal stoma.
  5. Patients with lesion <3 cm from anal verge or cancer involving anal sphincter
  6. preoperative chemo radiotherapy
  7. Previous left sided colorectal surgery or anorectal surgeries.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    antegrade colorectal single stapler anastomosis

    open end to end colorectal stapler anastomosis

    Arm Description

    open Side to end antegrade colorectal anastomosis colo rectal cancers.

    open end to end colorectal single anastomosis in non-emergent colo rectal cancers.

    Outcomes

    Primary Outcome Measures

    : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
    : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
    intestinal function
    intestinal function and LAR score

    Secondary Outcome Measures

    the overall postoperative morbidities
    the overall postoperative morbidities by clavien-dindo classification

    Full Information

    First Posted
    December 30, 2020
    Last Updated
    September 5, 2022
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04694521
    Brief Title
    Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial
    Official Title
    Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    September 2018 (Actual)
    Study Completion Date
    September 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Introduction: Cancer rectum and sigmoid is increasing nowadays. Resection and anastomosis is done laparoscopic approach with various techniques of anastomosis. Aim of this study: to compare between open side to end colorectal anastomosis versus laparoscopic end to end colorectal anastomosis in Non-emergent colo- rectal Cancers in adults as regard anastomotic leak, intestinal function and quality of life. Patients and Methods: Randomized controlled trial was performed on patients with Non-emergent colo rectal cancers between September 2016 and September 2018.
    Detailed Description
    ICancer rectum prevalence comes next to bronchogenic and prostatic malignant neoplasms in male, but it is the second cancer in female following cancer breast. [1] despite the fact that 1,000,000 patients notably every year and mortality by thousands, yet patients that live from this cancer is surging in the last years due to both sumptuous appliance of investigation and novel intervention techniques. Over two thirds of rectal cancer patients survived 5 years. [2]. Colorectal surgery principles target to merge the fulfillment of well-balanced free margin resection with bowel, urinary and potency activities. [3]. Laparoscopic rectal surgery for cancer had a famed corner in recent surgery that besieged open approach [4]. Rectal surgery has many troubles. The most troubled complication is anastomotic leakage. The prevalence of anastomotic leakage following rectal resection and anastomosis may wave to 15% of cases with high morbidity and mortality [5].The inauguration of the stapler in rectal surgery assisted the anastomosis to be in a homogeneous design, decrease strain on the suture, speedy surgery, no intra-abdominal contamination, no intrusion of anastomotic site perfusion and narrow the prevalence of anastomotic leakage. [6]. Resection of rectum is linked to low anterior resection syndrome (LARS) that usually affects quality of life [7]. 2. Aim of the work, gap statement and strength of the study: During rectal cancer surgery, no conclusive path of resection and anastomosis and usually followed by the surgeons according to their experience. In the current study, we have organized a randomized clinical trial to analyze the outcomes in two groups of patients with colo rectum cancers with two different laparoscopic approaches for resection and anastomosis. The primary aim was to correlate the prevalence of anastomotic leak after both interventions. The secondary aim was to appraise intestinal functional outcome and quality of life between both groups. Patients & Methods: 3.1 Study design and study power: This is a prospective randomized controlled trial managed in the colorectal surgical units of our University Hospitals (solitary-center) between September 2016 to September 2018. A total of 74 patients diagnosed as colorectal cancer underwent openrectal cancer surgery. The patients were randomly labeled into two groups: Group (A): included 37 patients: open side to end colorectal anastomosis (SEA) and Group (B): included 37 patients: openend to end colorectal anastomosis (EEA). As percentage of leakage from previous paper [8] was 29% VS 5.4% so sample will be 37 in each group with power 80% and confidence level 95% would be suitable to reach statistical significance (p<0.05). It is a simple random sample with a balance. Patients were randomly allocated using a random sequence computer. Patients were randomly numbered in closed envelopes, which were opened just before accomplishing the anastomosis intraoperative. Patients were unaware to the any group until after the study. It is the role of registration office.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    antegrade colorectal single stapler anastomosis
    Arm Type
    Experimental
    Arm Description
    open Side to end antegrade colorectal anastomosis colo rectal cancers.
    Arm Title
    open end to end colorectal stapler anastomosis
    Arm Type
    Experimental
    Arm Description
    open end to end colorectal single anastomosis in non-emergent colo rectal cancers.
    Intervention Type
    Procedure
    Intervention Name(s)
    openSide to end colorectal anastomosis .
    Intervention Description
    open Side to end colorectal anastomosis
    Intervention Type
    Procedure
    Intervention Name(s)
    open end end to end stapler anastomosis
    Intervention Description
    open end to end stapler anastomosis
    Primary Outcome Measure Information:
    Title
    : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
    Description
    : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.
    Time Frame
    30 days
    Title
    intestinal function
    Description
    intestinal function and LAR score
    Time Frame
    24 months after surgery.
    Secondary Outcome Measure Information:
    Title
    the overall postoperative morbidities
    Description
    the overall postoperative morbidities by clavien-dindo classification
    Time Frame
    within 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. colo rectum adenocarcinoma proved by biopsy and histo-pathological examination. 2. Only resections performed with immediate anastomosis, not under cover of stoma. 3. Expected R0 resection. 4. patients >18 years ,both sex 6. No previous history of stool or flatus incontinence, and clinically normal function of anal sphincter. Exclusion Criteria: Patients younger than 18 years , Pregnant female. Inability to understand the informed consent or refuse to participate or psychiatric patients. Patients with recurrent cancer, Irresectable tumour, widespread loco-regional, distant metastasis ,Combination operation and Complicated cancer e.g. obstructed or perforated. Cases covered by proximal stoma. Patients with lesion <3 cm from anal verge or cancer involving anal sphincter preoperative chemo radiotherapy Previous left sided colorectal surgery or anorectal surgeries. -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial

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