Anastomotic Leak, Sigmoid Diseases
Conditions
Keywords
anastomotic leak, doubled-stapled anastomosis
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.
Interventions
Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days | 30 days | anastomotic dehiscence diagnosis |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of surgery | 1 day |
| Rate of surgical reinterventions | 30 days |
| Rate Stoma closure | 1 year |
| Rate of Stoma-free survival | 1 year |
| Rate of hospital readmissions | 30 days |