Waiting list controlled trial of surgical treatment for adults with chronic constipation
| ISRCTN | ISRCTN11747152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11747152 |
| Secondary identifying numbers | 19016 |
- Submission date
- 30/09/2015
- Registration date
- 30/09/2015
- Last edited
- 27/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Constipation is a common condition which affects most people in their lifetime. Chronic constipation is where the sufferer has been affected for at least six months, and non-surgical treatments such as medications (laxatives), exercise and diet changes are ineffective. A laparoscopic ventral mesh rectopexy (LVMR) is a keyhole surgery procedure which is used to treat patients suffering from rectal prolapse (when the bowel slides out of the anus or slides in on itself). This procedure is designed to straighten and reattach the rectum (part of the bowel nearest to the anus) back into its normal position. The aim of this study is to find out whether LVMR could be an effective treatment for patients with chronic constipation who are unresponsive to standard treatment options.
Who can participate?
Adults with chronic constipation who are unresponsive to non-surgical treatment.
What does the study involve?
Eligible participants are randomly allocated into three groups, with different waiting times before their LVMR surgery. Those in the first group receive the surgery when they enter the study, those in the second group receive the surgery 12 weeks after entering the study, and those in the third group receive the surgery 24 weeks after entering the study. The effectiveness of the surgery on improving constipation symptoms and quality of life is measured using a number of questionnaires every 12 weeks (until 48 weeks), with the option of long term follow up to 72 weeks.
What are the possible benefits and risks of participating?
Participants may benefit from an improved quality of life as a result of taking part and will be carefully selected and monitored during the course of the study. The surgeons performing the surgery will also be carefully selected and monitored to ensure a high level of care. The risks of trial participation are very low over and above standard surgical risks and risks of anaesthesia. Radiological investigations (scans) routinely performed to select appropriate patients for surgery require a small ionising radiation dose, although this is not considered to be harmful. A number of questionnaires contain personal questions about bowel problems and the effect of these on quality of life and behaviour, which may be difficult for some participants.
Where is the study run from?
The Royal London & Whipps Cross Hospitals and nine other hospitals in England (UK)
When is the study starting and how long is it expected to run for?
July 2015 to March 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Natasha Stevens
Contact information
Scientific
Barts and The London School of Medicine and Dentistry
Centre for Neuroscience Trauma
Blizard Institute
2 Newark Street
London
E1 2AT
United Kingdom
Study information
| Study design | Randomised; Interventional and Observational; Design type: Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN11747152_PIS_V3.pdf |
| Scientific title | Stepped wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation |
| Study acronym | CapaCiTY03 |
| Study hypothesis | This trial aims to address the evidence gap for laparoscopic ventral mesh rectopexy (LVMR) and will assess the efficacy of LVMR for the treatment of adults with chronic constipation. |
| Ethics approval(s) | First Medical Research Ethics Committee, 06/07/2015, ref: 15-LO-0609 |
| Condition | Chronic constipation |
| Intervention | Patients are randomly allocated into three groups with different waiting times for the Laparoscopic Ventral Mesh Rectopexy (LapVMR) surgery. All groups have a run in period of 4 weeks to arrange surgery, with an average waiting time of 3 months. Group 1: The LVMR surgery is perfomed at T = 0 weeks Group 2: The LVMR surgery is perfomed at T = 12 weeks Group 3: The LVMR surgery is perfomed at T = 24 weeks Within the intervention, participants are admitted to hospital for at least one day post-operative care. The stepped wedged design allows data before surgery to be compared to data after surgery, effectively, patients act as their own controls. Post-operatively, patients are followed up after 1 day, after 30 days and once every 12 weeks to maximum 72 weeks. |
| Intervention type | Other |
| Primary outcome measure | Patient assessment of quality of life is assessed using the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire at 24 weeks post-surgery compared to pre-surgery controls. |
| Secondary outcome measures | 1. Quality of Life is measured using at 24, 48 and 72 weeks using the following questionnaires: 1.1. Patient Assessment of Constipation Symptom (PAC-SYM) total and individual domain scores 1.2. Patient Assessment of Constipation Quality of Life (PAC-QOL) total and individual domain score 1.3. Patient Health Questionnaire-9 (PHQ-9) 1.4. Generalized anxiety disorder questionnaire (GAD7) 1.5. Global patient satisfaction/improvement score (VAS) and whether they would recommend each treatment experienced to other patients 1.6. Chronic Constipation Brief Response Questionnaire (CC-BRQ), and brief illness perception questionnaire (BIPQ) 1.7. St Marks Incontinence score (for concurrent symptoms) 1.8. Baseline brief sexual function questionnaire (PISQ-12 for women and MSHQ-EjD Short Form for men) 1.9. A two week patient bowel diary (for 2 weeks prior to each assessment) to record bowel frequency and whether each evacuation was ‘spontaneous (no use of laxatives) and/or complete 2. Health Economics measured at 24, 48 and 72 weeks using a patient health journal and generic quality of life using the EQ-5D-5L descriptive system and EQ-VAS 3. Specific adverse events, morbidity and mortality data measured at 24, 48 and 72 weeks using: 3.1. Perioperative findings e.g. scarring, adhesions, tissue laxity, pelvic depth, ovarian or uterine pathology 3.2. Procedural data: duration of surgery, blood loss, approach (lap vs. conversion to open), type of mesh and sutures (make, diameter, number); 3.3. Length of post-operative stay 3.4. 30 day re-admission rates; 3.5. Complications (30-day morbidity and mortality) 3.6. Specific outcomes e.g. dyspareunia and sexual function, pelvic pain, urinary dysfunction, new onset-faecal incontinence, early mesh complications (displacement, erosion, infection). 3.7. Early clinical recurrence of structural defect e.g. prolapse or rectocele based on rectal examination +/- adjunctive investigations (as clinically indicated) 4. Qualitative Interviews to assess patient and health professional experiences. Method of measurement include semi structured, digitally recorded, anonymised and transcribed interviews. Interviews will be conducted with a subset of 20 patients and 5 surgeons, before and after surgery (timing will vary depending on group allocation) |
| Overall study start date | 01/07/2014 |
| Overall study end date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 114; UK Sample Size: 114; Description: 1:1:1 AllocationGrp 1: Lap VMR at T(0) = 38Grp 2: Lap VMR at T(12) = 38Grp 3: Lap VMR at T(24) = 38 |
| Total final enrolment | 28 |
| Participant inclusion criteria | 1. Aged between 18 and 70 years 2. Patient selfreports problematic constipation 3. Symptom onset > 6 months prior to recruitment 4. Symptoms meet American College of Gastroenterology definition of constipation 5. Constipation failed treatment to a minimum basic standard (NHS Map of Medicine 2012 (lifestyle AND dietary measures AND =2 laxatives or prokinetics) tried (no time requirement) 6. Ability to understand written and spoken English (due to questionnaire validity) 7. Ability and willingness to give informed consent 8. Failure of nonsurgical interventions (minimum of nurse led behavioural therapy) 9. Internal rectal prolapse as determined by clinical examination and INVEST |
| Participant exclusion criteria | 1. Significant organic colonic disease (red flag symptoms e.g. rectal bleeding prior investigated); IBD; megacolon or megarectum (if diagnosed beforehand); severe diverticulosis/stricture/birth defects deemed to contribute to symptoms (incidental diverticulosis if known not an exclusion) 2. Major colorectal resectional surgery 3. Current overt pelvic organ prolapse (bladder, uterus) or disease requiring obvious surgical intervention other than lap VMR 4. Previous rectopexy 5. Sacral nerve stimulation (SNS) in situ 6. Rectal impaction (as defined by digital and abdominal examination: these form part of the NHS Map of Medicine basic standard) 7. Significant neurological disease deemed to be causative e.g. Parkinson’s, spinal injury, multiple sclerosis, diabetic neuropathy (not uncomplicated diabetes alone) 8. Significant connective tissue disease: scleroderma, systemic sclerosis and SLE (not hypermobility alone) 9. Significant medical comorbidities and activity of daily living impairment (based on Bartell index in apparently frail patients Barthel index <=11) 10. Major active psychiatric diagnosis (e.g. schizophrenia, major depressive illness and mania) 11. Chronic regular opioid use (at least once daily use) where this is deemed to be the cause of constipation based on temporal association of symptoms with onset of therapy 12. Pregnancy or intention to become pregnant during study period 13. Known severe intraabdominal adhesions |
| Recruitment start date | 01/07/2015 |
| Recruitment end date | 30/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Whitechapel Road
London
E1 1BB
United Kingdom
Guy’s and Thomas’ NHS Foundation Trust
London
SE1 7EH
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Longfleet Road
Poole
BH15 2JB
United Kingdom
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
Court Road
Chelmsford
CM1 7ET
United Kingdom
Leeds
LS9 7TF
United Kingdom
Southend-on-Sea
Westcliff-On-sea
SS0 0RY
United Kingdom
Sponsor information
Hospital/treatment centre
-
London
E1 4NS
England
United Kingdom
"ROR" |
https://ror.org/026zzn846 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Publication is planned in July 2021. Scientific findings will be subjected to international reporting and peer review (targeting appropriate clinical journals e.g. BMJ, Lancet or Gastroenterology). The assimilation of data from this trial with those from other studies and convening of a national CC working group to consider the findings will lead to prototype national guidance that will inform NHS pathway development and commissioning of services. As such, it will be logical to initiate discussions with NICE for the development of a guideline for the management of CC in adults and to progress adoption by specialist medical and nursing organisations. Although the development of this guidance should naturally facilitate dissemination of the main programme findings to health care planners, policy makers and practitioners, we will also direct this information (and that of individual studies) to the following groups; Study participants and carers, charity links and patient groups, local health service providers, The Primary Care Society for Gastroenterology, school children via interactive learning tools and the NIHR HTC. Finally, we will repeat the highly successful 2 day international meeting entitled ‘Current perspectives in chronic constipation’ organised by Dr Scott and hosted by QMUL in February 2009 which was attended by over 250 scientists and clinicians and led to a supplement in the journal Neurogastroenterology & Motility dedicated to CC. This meeting is planned again for 2019 to coincide with the outputs of the programme. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a repository held by the Barts and the London Pragmatic Clinical Trials Unit, Queen Mary University of London. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3 | 03/05/2016 | No | Yes | |
| Protocol article | protocol | 05/02/2018 | Yes | No | |
| Results article | 19/05/2022 | 23/05/2022 | Yes | No | |
| Results article | 01/11/2021 | 27/10/2022 | Yes | No |
Additional files
- ISRCTN11747152_PIS_V3.pdf
- Uploaded 03/05/2016
Editorial Notes
27/10/2022: Publication reference added.
23/05/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
17/06/2021: The overall trial end date has been changed from 30/06/2021 to 01/03/2020 and the plain English summary has been updated accordingly.
20/05/2021: Internal review.
03/04/2019: The condition has been changed from "Topic: Surgery, Gastroenterology; Subtopic: Surgery, Gastroenterology; Disease: All Gastroenterology" to "Chronic constipation" following a request from the NIHR.
08/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 30/06/2019.
2. The overall trial end date was changed from 30/06/2020 to 30/06/2021.
3. The intention to publish date was changed from 01/07/2020 to 01/07/2021.
14/02/2018: Publication reference added.
10/01/2018: Mrs Shiva Taheri replaced Ms Natasha Stevens as primary study contact.
13/06/2017: The overall trial end date has been updated from 01/06/2019 to 30/06/2020 and the recruitment end date has been updated from 01/07/2017 to 30/06/2018. In addition, Southampton General Hospital and Derriford Hospital have been removed as participating sites and St. James's University Hospital and Southend University Hospital NHS Foundation Trust have been added. The IPD sharing statement has also been added.
03/05/2016: Participant information sheet and trial website added.
22/04/2016: The 96 week timepoint has been removed from the secondary outcome measures. All secondary outcomes are now measured at 24, 48 and 72 weeks. Additionally, Measure Yourself Medical Outcome Profile MYMOP2 questionnaire has been removed from the list of questionnaires that measure quality of life.
