Lateral Invagination of the Colorectal Anastomosis by Double Stapling

February 9, 2021 updated by: Antonio M Lacy, Hospital Clinic of Barcelona

Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

786

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional technique
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
Procedure: Doubled-stapled colorectal anastomosis
Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.
Active Comparator: Lateral invagination technique
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.
Procedure: Doubled-stapled colorectal anastomosis
Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days
Time Frame: 30 days
anastomotic dehiscence diagnosis
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of surgery
Time Frame: 1 day
1 day
Rate of perioperative morbidity using the Clavien-Dindo classification.
Time Frame: 30 and 90 days PO or in-hospital stay
30 and 90 days PO or in-hospital stay
Rate of perioperative mortality
Time Frame: 30 and 90 days PO or in-hospital stay
30 and 90 days PO or in-hospital stay
Duration of hospital stay
Time Frame: days
days
Rate of hospital readmissions
Time Frame: 30 days
30 days
Rate of surgical reinterventions
Time Frame: 30 days
30 days
Rate Stoma closure
Time Frame: 1 year
1 year
Rate of Stoma-free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2020/1057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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