Randomized clinical trial of sacral nerve stimulation for refractory constipation.
Br J Surg
; 104(3): 205-213, 2017 Feb.
Article
in En
| MEDLINE
| ID: mdl-27779312
ABSTRACT
BACKGROUND:
Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT.METHODS:
Patients with at least two of the following criteria were included fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year.RESULTS:
Thirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time.CONCLUSION:
These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number NCT01629303 (http//www.clinicaltrials.gov).
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Electric Stimulation Therapy
/
Constipation
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Lumbosacral Plexus
Type of study:
Clinical_trials
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Guideline
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Observational_studies
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Prognostic_studies
Limits:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
Br J Surg
Year:
2017
Document type:
Article
Affiliation country: