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Lateral Invagination of the Colorectal Anastomosis by Double Stapling

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04553250
Enrollment
786
Registered
2020-09-17
Start date
2021-03-01
Completion date
2023-01-01
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Sigmoid Diseases

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

PROCEDUREDoubled-stapled colorectal anastomosis

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

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days30 daysanastomotic dehiscence diagnosis

Secondary

MeasureTime frame
Rate of perioperative morbidity using the Clavien-Dindo classification.30 and 90 days PO or in-hospital stay
Rate of perioperative mortality30 and 90 days PO or in-hospital stay
Duration of hospital staydays
Duration of surgery1 day
Rate of surgical reinterventions30 days
Rate Stoma closure1 year
Rate of Stoma-free survival1 year
Rate of hospital readmissions30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026