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Lateral Invagination of the Colorectal Anastomosis by Double Stapling

NCT04553250 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 786

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

  • Anastomotic Leak
  • Sigmoid Diseases

Interventions

PROCEDURE

Doubled-stapled colorectal anastomosis

Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-01-01
Completion
2023-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553250 on ClinicalTrials.gov