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60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy.
The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Crohn Disease | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ileocolic resection with extended mesenteric resection | Procedure | The resection limits will be in healthy mesenteric areas. The restoration of continuity in one stage should be preferred. The choice of laparoscopy versus laparotomy is at the surgeon's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical complication rate | Percentage, graded according to the Clavien-Dindo Classification | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative endoscopic recurrence | Yes/No according to Rutgeerts classification (i0-i4), using a cut-off score ≥ i2 | 6 months |
| Surgical time of the ileocolic resection technique | Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin BERTRAND | Contact | 04 66 68 31 43 | martin.bertrand@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Martin BERTRAND | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier Hôpital St Eloi | Recruiting | Montpellier | France |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| End of surgery |
| Intraoperative bleeding | If yes, volume (ml) | End of surgery |
| Length of hospital stay | Days | End of hospitalization (max 1 month) |
| Presence of intra- and post-operative complications | Yes/no | Immediately following surgery |
| Number of intra- and post-operative complications | Number | Immediately following surgery |
| Time until resumption of transit following surgery | Number of days between surgery and resumption of transit | Following surgery (maximum 5 days) |
| Time until resumption of eating | Number of days between surgery and resumption of eating | Following surgery (average 1 day) |
| Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin | Classed as: Absent; 1-3 inflammatory cells; 4-9; or 10+ | Immediately following surgery |
| Number of lymph nodes in the histological specimen | Number | Immediately following surgery |
| Resection not in healthy margin | (Yes/No) | Immediately following surgery |
| Length of resected digestive tract | Centimeters | Immediately following surgery |
| Area of mesentery removed | Square centimeters | Immediately following surgery |
| C-reactive protein level | Day before surgery |
| C-reactive protein level | Day 2 |
| C-reactive protein level | Day 4 |
| C-reactive protein level | Month 1 |
| C-reactive protein level | Month 6 |
| Albuminemia | Day before surgery |
| Hemoglobinemia | Day before surgery |
| Hemoglobinemia | Day 2 |
| Hemoglobinemia | Day 4 |
| White blood cells | Day before surgery |
| White blood cells | Day 2 |
| White blood cells | Day 4 |
| Fecal calprotectin | Month 3 |
| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
|
| D007410 | Intestinal Diseases |