Perioperative medicine & outcomes
Preoperative Weight Loss in Patients With Excess Weight and Colorectal Cancer: The CARE Feasibility Randomized Clinical Trial
Primary result · Progression criteriaResult — go to the resultOdds ratio 16.8 95% CI 4.3–65.3Authors' conclusion
This randomized clinical trial's intervention of low-energy total diet replacement before colorectal cancer resection was feasible and well tolerated, lacked safety concerns, and was likely cost-effective.
Study context
- Population
- Adults with BMI ≥28 awaiting curative elective colorectal cancer resection at 8 hospitals in Englandincluded in the analysis
- Participants
- 71 adults
- Comparison
- Preoperative low-energy total diet replacement vs usual care
- Interventionn = 36
- Usual caren = 35reference
- Primary endpoint
- Progression criteria: recruitment (≥72 patients), engagement (≥75% of dietetic calls attended), adherence (≥60% of intervention participants achieving ≥5% weight loss), retention (≥85%)
Methodological detailsassessor-blinded, feasibility, multicentre
- Assessor-blinded
- Feasibility
- Multicentre
Primary result
Progression criteria
Odds ratio
16.8
95% CI 4.3–65.3
Events by treatment group
Intervention vs Usual care
OR 16.8 (95% CI 4.3–65.3)
As reported in the abstract
- Recruitment: 71 randomised; accrual rate per site per month (anticipated 0.75)
- 0.57
- Engagement: dietetic calls attended
- 85%
- Retention
- 100%
Secondary outcomes
| Outcome | Intervention | Difference (kg) (95% CI) | |
|---|---|---|---|
| Weight loss before surgery | mean 6.1 (SD 3.0) kg | 4.3 (2.7–5.8) | |
| −50510Difference, kg (linear scale) |
| Outcome | Difference (points) (95% CI) | |
|---|---|---|
| Fecal incontinence · postoperativelyImproved in intervention group | −8.6 (−16.7 to −0.5) | |
| Sore skin · postoperativelyImproved in intervention group | −15.9 (−25.3 to −6.6) | |
| −40−20020Difference, points (linear scale) |
Fat-free mass
- Between-group adjusted change in fat-free mass
- 0.1 kg (95% CI, −3.9 to 4.0 kg)
Any complications
- No evidence of a difference between the 2 groups in any complications
- 14 [39%] vs 14 [40%]
- No evidence of a difference in Clavien-Dindo grade I, II, or III complications
Complications by weight loss ≥3.2% (above median loss)
- Relative reduction in complications with ≥3.2% body weight loss
- 50% (95% CI, 1%-78%)
- Exploratory observational analysis
Cost-effectiveness (30-year modeling)
- Modeling indicated the intervention was cost-effective
Safety
- No intervention-related serious adverse events
Original publication
Preoperative Weight Loss in Patients With Excess Weight and Colorectal Cancer: The CARE Feasibility Randomized Clinical Trial. JAMA Netw Open. Published 1 December 2025. doi:10.
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