Clinical trial NCT04553250: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Leak
Sigmoid Diseases
Keywords: anastomotic leak
doubled-stapled anastomosis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 786
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days
timeFrame: 30 days
Secondary outcomes:
measure: Duration of surgery
timeFrame: 1 day
measure: Rate of perioperative morbidity using the Clavien-Dindo classification.
timeFrame: 30 and 90 days PO or in-hospital stay
measure: Rate of perioperative mortality
timeFrame: 30 and 90 days PO or in-hospital stay
measure: Duration of hospital stay
timeFrame: days
measure: Rate of hospital readmissions
timeFrame: 30 days
measure: Rate of surgical reinterventions
timeFrame: 30 days
measure: Rate Stoma closure
timeFrame: 1 year
measure: Rate of Stoma-free survival
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
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