Lateral Invagination of the Colorectal Anastomosis by Double Stapling

Study Overview
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Brief Summary
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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.

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

Conditions
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Anastomotic Leak, Sigmoid Diseases

Intervention / Treatment
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* Procedure: Doubled-stapled colorectal anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional technique<br>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<br>* Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.<br>|
| Active Comparator: Lateral invagination technique<br>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<br>* Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anastomotic leak, doubled-stapled anastomosis