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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
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.
CHU de Montpellier Hôpital St Eloi
Montpellier, France
RECRUITINGCHU de Nîmes
Nîmes, France
RECRUITINGPost-surgical complication rate
Percentage, graded according to the Clavien-Dindo Classification
Time frame: 30 days after surgery
Postoperative endoscopic recurrence
Yes/No according to Rutgeerts classification (i0-i4), using a cut-off score ≥ i2
Time frame: 6 months
Surgical time of the ileocolic resection technique
Minutes
Time frame: End of surgery
Intraoperative bleeding
If yes, volume (ml)
Time frame: End of surgery
Length of hospital stay
Days
Time frame: End of hospitalization (max 1 month)
Presence of intra- and post-operative complications
Yes/no
Time frame: Immediately following surgery
Number of intra- and post-operative complications
Number
Time frame: Immediately following surgery
Time until resumption of transit following surgery
Number of days between surgery and resumption of transit
Time frame: Following surgery (maximum 5 days)
Time until resumption of eating
Number of days between surgery and resumption of eating
Time frame: 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+
Time frame: Immediately following surgery
Number of lymph nodes in the histological specimen
Number
Time frame: Immediately following surgery
Resection not in healthy margin
(Yes/No)
Time frame: Immediately following surgery
Length of resected digestive tract
Centimeters
Time frame: Immediately following surgery
Area of mesentery removed
Square centimeters
Time frame: Immediately following surgery
C-reactive protein level
Time frame: Day before surgery
C-reactive protein level
Time frame: Day 2
C-reactive protein level
Time frame: Day 4
C-reactive protein level
Time frame: Month 1
C-reactive protein level
Time frame: Month 6
Albuminemia
Time frame: Day before surgery
Hemoglobinemia
Time frame: Day before surgery
Hemoglobinemia
Time frame: Day 2
Hemoglobinemia
Time frame: Day 4
White blood cells
Time frame: Day before surgery
White blood cells
Time frame: Day 2
White blood cells
Time frame: Day 4
Fecal calprotectin
Time frame: Month 3
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