Waiting list controlled trial of surgical treatment for adults with chronic constipation

Conditions

Chronic constipation Digestive System Constipation

Natasha Stevens, Shiva Taheri, Ugo Grossi, Chris Emmett, Sybil Bannister et al. (9 authors)

BMC Medical Research Methodology2024-11-14

10.1186/s12874-024-02395-z

Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation

Ugo Grossi, Jon Lacy‐Colson, Steven R. Brown, Samantha Cross, Sandra Eldridge et al. (12 authors)

Techniques in Coloproctology2022-05-198 citations

10.1007/s10151-022-02633-w

Non-drug therapies for the management of chronic constipation in adults: the CapaCiTY research programme including three RCTs

Charles H. Knowles, Lesley Booth, Steven R. Brown, Samantha Cross, Sandra Eldridge et al. (17 authors)

Programme Grants for Applied Research2021-11-0114 citations

10.3310/pgfar09140

Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial.

Grossi U, Stevens N, McAlees E, Lacy-Colson J, Brown S, Dixon A, Di Tanna GL, Scott SM, Norton C, Marlin N, Mason J, Knowles CH, NIHR CapaCiTY working group.

2018-02-057 citations

10.1186/s13063-018-2456-3

Interventions

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 surge

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 i	—

Measure

Time frame

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 i

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Countries

England, United Kingdom

Outcome results

None listed