Colo-colonic Anastomoses, Ileo-colonic Anastomoses
Conditions
Keywords
Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery
Brief summary
The purpose of this study is to examine the frequency of postoperative complications depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer suture.
Interventions
PROCEDUREdouble layer-suture
Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
PROCEDURESingle-layer suture
Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)
Sponsors
Universitätsmedizin Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years old, * planned for elective surgery * at least one hand-sutured ileo-colonic or colo-colonic anastomosis
Exclusion criteria
* ASA-Score \> 3, * missing written consent of the informed patient * no existing choice between suture-techniques according to the surgeon * patient not able to cooperate/non-compliance * rectal anastomoses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of clinical anastomostic leaks | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| death of any cause within 3 months post-operatively | 3 months | all causes of death will be recorded independently of a possible causal relationship with the operation |
| postoperative morbidity | 30 days | — |
| Duration of anastomosis (min) | 1-3 hours | — |
| Frequency of anastomotic strictures | 3 months | — |
Countries
Germany
Outcome results
None listed