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Lateral Invagination of the Colorectal Anastomosis by Double Stapling

Primary Purpose

Anastomotic Leak, Sigmoid Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doubled-stapled colorectal anastomosis
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anastomotic Leak focused on measuring anastomotic leak, doubled-stapled anastomosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age> 18 years
  • Indication of resection of the left colon, sigmoid or upper rectum
  • Minimally invasive approach
  • Open surgery approach
  • Double staple colorectal anastomosis
  • Signed informed consent for inclusion in the study

Exclusion Criteria:

  • Patients <18 years
  • Pregnancy
  • ASA> III
  • Absolute contraindication for anesthesia
  • Patients who receive more than 1 gastrointestinal anastomosis during the same procedure
  • Planned multi-organ resection during the same procedure
  • Urgent / emergent surgery
  • Reinforced anastomosis after positive intraoperative leak test
  • Patients with simultaneous application of debulking and HIPEC
  • Crohn's disease or active ulcerative colitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Conventional technique

    Lateral invagination technique

    Arm Description

    In this group, double-staple colorectal anastomosis will be performed following the technique described by Lee et al: Prior to firing the endostapler, a suture will be placed on the rectal stump that includes both "dog ears". After the punch comes out of the endostapler, the point will be tied, which will invaginate the two corners of the staple line on the same punch. Subsequently, the endostapler will be closed and fired, including the "dog ears" in the anastomotic rims

    In this group, the circular endostapler will be fired in a conventional way, that is, without having invaginated the two corners of the staple line.

    Outcomes

    Primary Outcome Measures

    Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days
    anastomotic dehiscence diagnosis

    Secondary Outcome Measures

    Duration of surgery
    Rate of perioperative morbidity using the Clavien-Dindo classification.
    Rate of perioperative mortality
    Duration of hospital stay
    Rate of hospital readmissions
    Rate of surgical reinterventions
    Rate Stoma closure
    Rate of Stoma-free survival

    Full Information

    First Posted
    September 11, 2020
    Last Updated
    February 9, 2021
    Sponsor
    Hospital Clinic of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04553250
    Brief Title
    Lateral Invagination of the Colorectal Anastomosis by Double Stapling
    Official Title
    Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Clinic of Barcelona

    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
    Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses [1-4]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. In addition, several studies point to an increased risk of locoregional recurrence [5, 6]. There are different risk factors for anastomotic dehiscence: some preoperative, such as malnutrition or obesity [9]; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication [7]. In colorectal anastomoses, there is some concern about the safety of the double stapling technique, since the extremes of the linear suture line (called "dog ears") and the number of staple lines have a direct relationship with the risk of dehiscence [8-11]. With the aim of reducing suture dehiscence rates, different intraoperative techniques have been developed, such as reinforcing the anastomosis with stitches, the use of indocyanine green [12, 13] or the application of anastomotic sealants [14], without finding a definitive solution. Recently, benefits have been published of using the double-staple colorectal anastomosis lateral invagination technique, with the aim of avoiding "dog ears" [15-17]. Several case series and retrospective comparative studies have shown a significant decrease in anastomotic dehiscence using this technique, with all the clinical and economic benefits that this entails [15-17]. In this sense, the present study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anastomotic Leak, Sigmoid Diseases
    Keywords
    anastomotic leak, doubled-stapled anastomosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    786 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional technique
    Arm Type
    Active Comparator
    Arm Description
    In this group, double-staple colorectal anastomosis will be performed following the technique described by Lee et al: Prior to firing the endostapler, a suture will be placed on the rectal stump that includes both "dog ears". After the punch comes out of the endostapler, the point will be tied, which will invaginate the two corners of the staple line on the same punch. Subsequently, the endostapler will be closed and fired, including the "dog ears" in the anastomotic rims
    Arm Title
    Lateral invagination technique
    Arm Type
    Active Comparator
    Arm Description
    In this group, the circular endostapler will be fired in a conventional way, that is, without having invaginated the two corners of the staple line.
    Intervention Type
    Procedure
    Intervention Name(s)
    Doubled-stapled colorectal anastomosis
    Intervention Description
    Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.
    Primary Outcome Measure Information:
    Title
    Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days
    Description
    anastomotic dehiscence diagnosis
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Duration of surgery
    Time Frame
    1 day
    Title
    Rate of perioperative morbidity using the Clavien-Dindo classification.
    Time Frame
    30 and 90 days PO or in-hospital stay
    Title
    Rate of perioperative mortality
    Time Frame
    30 and 90 days PO or in-hospital stay
    Title
    Duration of hospital stay
    Time Frame
    days
    Title
    Rate of hospital readmissions
    Time Frame
    30 days
    Title
    Rate of surgical reinterventions
    Time Frame
    30 days
    Title
    Rate Stoma closure
    Time Frame
    1 year
    Title
    Rate of Stoma-free survival
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age> 18 years Indication of resection of the left colon, sigmoid or upper rectum Minimally invasive approach Open surgery approach Double staple colorectal anastomosis Signed informed consent for inclusion in the study Exclusion Criteria: Patients <18 years Pregnancy ASA> III Absolute contraindication for anesthesia Patients who receive more than 1 gastrointestinal anastomosis during the same procedure Planned multi-organ resection during the same procedure Urgent / emergent surgery Reinforced anastomosis after positive intraoperative leak test Patients with simultaneous application of debulking and HIPEC Crohn's disease or active ulcerative colitis

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    Lateral Invagination of the Colorectal Anastomosis by Double Stapling

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