To understand if handsewn (end to end and Kono S side to side) anastomoses is superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Endoscopic recurrence at six months following ileocolic resection defined as
SES-CD of the terminal ileum >2 and Rutgeerts >i2b by central reading.
Primary Objective: Recurrence at six months following ileocolic resection
defined as Rutgeerts
>i2b assessed by local and central reading separately for comparison blinded
for the type of anastomoses. The quality of endoscopic scoring and over scoring
will be assessed comparing local scoring by the treating gastroenterologist and
the central reading scoring for the different types of anastomoses.
Secondary outcome
Secondary Objectives:
• Post-operative 30 days complications
• Histologic and clinical recurrence at 6 months
• Clinical recurrence within 1 year
• Need for restarting immunosuppressive medication within the first year
postoperatively for endoscopic or clinical recurrence.
• QOL as measured by EuroQol, IBDQ and SF-36 at baseline and at 6 months
• Health care consumption and costs of readmission, outpatient clinic and
diagnostics
• The 5 year reoperation rate for recurrence of disease at the anastomotic
site.
Background summary
Half of the surgeries for intestinal Crohn*s disease comprises of (re)resection
of the (neo)terminal ileum. Unfortunately, surgery for CD is not curative, and
disease recurrence is common with up to 60% having endoscopic recurrence at six
months. According to the ECCO guidelines endoscopic assessment of recurrence is
advised 6 months after surgery and scored with the modified Rutgeerts
classification. The scoring has prognostic implications, is used to restart
medical therapy and is a common endpoint in trials. Wound healing of inverted
stapled anastomosis is essentially different from handsewn anastomosis and is
associated with ulcerations at the staple line leading to systematic over
scoring of Crohn's recurrence. The patient is unjustly diagnosed with disease
recurrence leading to unnecessary restarting of expensive drugs compromising
the QOL and increasing costs. In addition, the side-to-side configuration might
cause stasis which fuels recurrence and gastrointestinal dysfunction.
Therefore we hypothesize that the end to end or kono-S handsewn anastomosis
compared to the stapled side to side anastomosis shows less ulcerations at 6
months after surgery scored with the SES-CD either at the site of the
anastomosis (different type of healing) and in the afferent ileum (stasis). We
also hypothesize that this type of anastomosis is associated with less
abdominal complaints and therefore is more sustainable.
Study objective
To understand if handsewn (end to end and Kono S side to side) anastomoses is
superior to side to side stapled anastomosis after ileocolic resection for
Crohn's disease with respect to endoscopic recurrence, gastrointestinal
function and costs.
Study design
The study design is a Monocenter Randomized superiority trial
Intervention
The following groups will be compared:
Group 1 (intervention): Handsewn end to end anastomosis (end to end or Kono-s)
Group 2 (standard): Stapled side to side anastomosis
Study burden and risks
All patients will undergo am ileocolic resection or resection of the
neoterminal ileum for Crohns disease. According to the ECCO guidelines the
preferred anastomose technique is a stapled ileocolic side-to-side anastomose.
However, both the handswen anastomosis and the stapled anastomos, are
well-known and commonly performed standard treatment approaches that are
currently used for CD or colon carcinoma. Both procedures will be performed as
a laparoscopic resection with conversion to an open operation only if
clinically indicated. Prior to surgery, all patients will have colonoscopy with
biopsy, and a MR or CT enterography performed. Operative data and thirty-day
postoperative data will be collected. At 6 months, and if clinically indicated
at one year, patients will undergo colonoscopy with biopsies taken from the
distal ileum and proximal colon on either side of the anastomosis to assess
endoscopic and histologic recurrence. Endoscopic recurrence will be assessed by
local central reading. In literature, the 6 months endoscopic recurrence rate
(defined as Rutgeerts >=i2b) is estimated to be around 60%.
To detect a difference of 25% endoscopic recurrences at 6 months between the
two randomized surgeries, a total number of 165 patient is needed (included
lost to follow-up).
Patients will be assessed at 4 weeks, 3 months, 6 months and 12 months.The
Crohn*s Disease Activity Index (CDAI) is determined at baseline visit based on
seven day scoring by the patient prior to this visit. Moreover, quality of life
questionnaires are administered at baseline and each visit: EuroQol, a five
dimensions questionnaire (EQ-5D), 36-Item Short Form Health Survey (SF-36), and
Inflammatory Bowel Disease Questionnaire (IBDQ).The iMCQ and iPCQ
questionnaires are administered at 3 months, 6 months and 12 months
postoperatively as part of the economic evaluation of the different surgical
interventions.
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Males and females aged >16 years
2. Ileocolic disease or disease of the neoterminal ileum with an indication for
resection
3. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX,
antibiotics, and anti-TNF therapy are permitted.
4. All patients should have ileocolic disease or disease of the neoterminal
ileum previously confirmed during endoscopy, with a recent update of imaging
(e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))
5. Ability to comply with protocol.
6. Competent and able to provide written informed consent.
7. Patiënt must have been discussed in the local MDT
Exclusion criteria
1. Inability to give informed consent.
2. patients less than 16 years of age.
3. Clinically significant medical conditions within the six months before the
operation : e.g. myocardial infarction, active angina, congestive heart failure
or other conditions that would, in the opinion of the investigators, compromise
the safety of the patient.
4. History of cancer < 5 years which might influence patients prognosis
5. Emergent operation.
6. Pregnant or breast feeding.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05578235 |
| CCMO | NL81981.018.22 |