Adhesive Small Bowel Obstruction
Conditions
Keywords
Tissue adhesions, Adhesiolysis, Surgery
Brief summary
Rationale: Adhesive small bowel obstruction (aSBO) is a frequent surgical emergency, associated with 3-8% hospital mortality and a high risk of recurrence (20% at two years of follow-up). ASBO can be treated conservatively or by emergency surgery. In the absence of bowel ischemia or strangulation, conservative treatment is often preferred, to avoid the excess morbidity and mortality from emergency surgery. Recent epidemiological studies, however, demonstrate a considerable higher recurrence risk of aSBO after conservative treatment that is associated with hospital readmissions and lower survival. Elective adhesiolysis following successful conservative treatment might reduce these long-term risks whilst avoiding the high complication rate of emergency surgery. Objective: The investigators aim to assess the efficacy of elective adhesiolysis following conservative treatment for aSBO as compared to the current state of the art (wait-and-see policy) to prevent long-term recurrence of aSBO. Further the investigators will evaluate quality of life, healthcare and societal costs. Study design: Multicenter open-label randomized controlled trial, including 380 patients. Study population: Adult patients who recovered from aSBO by conservative treatment. Patients that are inoperable for medical, anaesthesiological or surgical reasons are excluded. Intervention (if applicable): The intervention of investigation is elective adhesiolysis. Adhesiolysis is an abdominal procedure in which all adhesions are cut, and adhesion prevention applied to reduce the risk of adhesion reformation. The intervention is compared to wait-and-see policy (the current standard treatment) Main study parameters/endpoints: Primary outcome is recurrence, defined as readmission for obstructive systems with aetiology of adhesions confirmed by CT. The investigators hypothesize a 50% reduction in recurrence in the intervention arm. Secondary outcomes are morbidity from surgery, health-related quality of life (EQ5D), healthcare costs and societal costs (iMCQ and iPCQ) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the intervention group are exposed to abdominal surgery, which is associated with a moderate risk of minor complications such as wound infection and haemorrhage, and a small risk of severe complications such as iatrogenic bowel injury. According to our hypothesis, a potential benefit is the reduction in the risk of recurrences. Recurrence of aSBO is associated with a risk of readmissions, reinterventions, and also increased long-term mortality.
Interventions
PROCEDUREElective Adhesionlysis
See descriptions in study arms
DEVICEAdhesion barrier
At the end of adhesiolysis a barrier will be placed. The adhesion barrier to be used in laparoscopic adhesiolysis is Icodextrin 4% (Adepttm).
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
KCE Belgian Healthcare Knowledge Centre
Baxter Healthcare Corporation
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter open-label randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 years and older who have recently recovered from aSBO by small bowel obstruction managed by conservative treatment. * Patients who have previously been operated (high a prior risk of adhesions) are required to have no signs of other causes of bowel obstruction on imaging studies (CT-scan). * Patients with no previous operation in history (low a prior risk of adhesions) are required to have typical signs for aSBO on imaging studies (abrupt change of bowel calibre, closed loop, or signs of torsion on vessels in the mesentery on CT-scan).
Exclusion criteria
* Patient who are unfit for reoperation for surgical, anesthesiological or medical reasons as determined by multidisciplinary team assessment or pre-operative screening * Patients with active malignancy, reducing life expectancy * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence of ASBO at 2-years of follow-up | 2 years | Recurrence is defined as a readmission for symptoms of small bowel obstruction, including lower abdominal pain, bloating and nausea with or without vomiting. In addition imaging by CT-scan should not show indications of other causes of bowel obstruction (such as an incarcerated abdominal wall hernia or tumour), which is over 90% accurate for the diagnosis of ASBO. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Societal costs | 2 years | measured by modified iMCQ |
| Recurrence at 5 year | 5 years | (identified by record linking\[BE\] or general practitioner data\[NL\]) |
| Recurrences needing surgery | 2 years and 5 years | ASBO recurrence requiring emergency surgery |
| Healthcare costs | 2 years | measured by modified iMCQ |
| Health related quality of life | 2 years | \- Health-related quality of life measured by EQ5D |
| Gastro-intestinal related quality of life | 2 years | \- Gastro-intestinal related quality of life measured by GIQLI |
| Cost-effectiveness | 2 years and 5 years | incremental cost-effectiveness ratio, i.e. cost per QALY |
| Morbidity from elective adhesiolysis | 90 days | Composite of: * Serious adverse events and complications, graded by Clavien-Dindo score. * Intra-operative events (i.e. bowel injury), graded by ClassIntra® * ICU admission * Reinterventions within 90 days |
Countries
Belgium, Netherlands
Contacts
Primary ContactRichard PG ten Broek, MD, PhD
Outcome results
None listed