CapaCiTY Study 3- Chronic Constipation Treatment Pathway
Research type
Research Study
Full title
STEPPED WEDGE RANDOMISED TRIAL OF LAPAROSCOPIC VENTRAL MESH RECTOPEXY IN ADULTS WITH CHRONIC CONSTIPATION
IRAS ID
171006
Contact name
Natasha Stevens
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Laparoscopic ventral mesh rectopexy (Lap VMR) is an established key hole operation for correcting rectal prolapse (when the bowel slides out of the anus or slides in on itself). It is now being widely performed internationally (including many centres in UK) on large numbers of patients with defaecatory problems and evidence of pelvic floor weakness. This trial aims to address the evidence gap for lap VMR and will assess the efficacy of Lap VMR for the treatment of adults with chronic constipation. Chronic constipation can be defined as self reported symptoms persisting for more than 6 months, failure of conservative treatments to a minimum basic standard (diet and lifestyle advice, and >= 2 laxatives and prokinetics). Eligible patients will have previously attempted nurse led behavioural therapy without sufficient relief of symptoms, and be eligible for Lap VMR based on clinical and physiological investigations. The study design requires 114 patients to be randomly allocated to three groups with different waiting times for surgery. This allows patients to act as their own control whilst ensuring all patients receive the intervention. In all arms there will be a period of 4 weeks post-eligibility to arrange the logistics of surgery (T-4w to T0) and ensure that patients have returned to their normal life routine after various screening assessments. In group I lap VMR will be performed at T0; in group II it will be performed at 12 weeks (T12) and in group III it will be performed at 24 weeks (T24). Efficacy outcome data will be collected at further equally stepped time points (T 12, 24, 36, 48 weeks).
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0609
Date of REC Opinion
6 Jul 2015
REC opinion
Further Information Favourable Opinion