Crohn Disease
Conditions
Keywords
Crohn disease, ileocecal resection, anastomosis, Kono
Brief summary
Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD). This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis. In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery. Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.
Interventions
PROCEDUREKono anastomosis
Kono anastomosis
PROCEDUREStapled side-to-side anastomosis
Stapled side-to-side anastomosis
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Crohn's disease requiring ileocecal resection
Exclusion criteria
* age \> 75 years * age \< 18 years * inability to give the consent to the participation in the trial * refusal to participate in the trial after receiving accurate information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade of endoscopic recurrence | 6 Months | Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery. |
| Surgical recurrence | Up to 5 years | Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade of endoscopic recurrence | 6 months up to 5 years | Severity of endoscopic recurrence at the site of anastomosis |
| Clinical recurrence | Up to 5 years | Presence of clinical recurrence (according to Crohn's disease activity index) |
| Operating time | Intraoperatively | Duration of the operation (min) |
| Surgical re-intervention | Up to 30 days | Rate of patients requiring surgical re-intervention |
| Anastomotic leak | Up to 30 days | Incidence of anastomotic leak |
| Postoperative morbidity rate | Up to 30 days | Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification |
| Recovery times | Participants will be followed for the duration of hospital stay, an expected average of 5 days | Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented |
| Anastomosis time | Intraoperatively | Time (min) required to perform the anastomosis |
| Endoscopic recurrence | 6 months up to 5 years | Presence of endoscopic recurrence |
Countries
Italy
Contacts
Primary ContactLuigi Bucci, Prof
Outcome results
None listed