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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048220
Enrollment
786
Registered
2022-07-01
Start date
2020-12-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Colorectal cancer

Interventions

Anastomosis with double stapling technique Anastomosis with lateral invagination technique

Sponsors

HOSPITAL CLINIC DE BARCELONA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 frame
Evaluate the rate of anastomotic dehiscence diagnosed in the first 30 postoperative days.

Secondary

MeasureTime frame
1. Duration of surgery (min) 2. Perioperative morbidity (TF: 30 and 90 days postoperative, or in hospital) using the Clavien- Dindo classification. 3. Perioperative mortality (TF: 30 and 90 days postoperative, or in hospital) 4. Hospital stay. 5. Hospital readmissions 6. Surgical reinterventions 7. Stoma-free survival 1 year after surgery

Countries

Japan,Europe

Contacts

Public ContactCarolina Gonzalez

HOSPITAL CLINIC DE BARCELONA GASTROINTESTINAL SURGERY DEPARTMENT

carol.gonzaleza@gmail.com34932275402

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026