High-resolution colon manometry in patients suffering from LARS symptoms after surgery for rectal cancer.

Phase 4

Completed

Conditions: <p>rectal cancer, low anterior resection syndrome, LARS, fecal incontinence, fecal urgency, frequency, fragmented defecation, soiling, bowel symptoms</p>
rectal cancer
10017991

Registration Number: NL-OMON28500

Lead Sponsor: Flanders Research Foundation

Brief Summary: Although references to the ‘Low Anterior Resection Syndrome’ (LARS) are omnipresent, the exact pathophysiological mechanisms continue to be an enigma to date. Consequently, for this study, we utilized the state-of-the-art technique of high-resolution colon manometry to explore colonic motor patterns in patients who suffered from varying degrees of LARS. One to two years after restoration of transit, patients after TME were asked to enter the study protocol and undergo high-resolution colon manometry. Colonic motor patterns were analysed and occurrences were compared between nine patients with major LARS and nine patients with no/minor LARS. A differentiation between six different colonic motor patterns was made: (1) + (2) short single propagating motor pattern (antegrade/retrograde), (3) + (4) long single propagating motor pattern (antegrade/retrograde), (5) simultaneous pressure wave and (6) high amplitude propagating contraction (HAPC). Furthermore, the relationship of the motor patterns with the LARS-scores was investigated. Results demonstrated that patients with major LARS showed significantly more cyclic short antegrade motor patterns overall, as well as post-bisacodyl (= a laxative) administration. This type of pattern also showed to be strongly correlated to the LARS-scores. Regarding other patterns, no other significant correlations were found with the LARS-scores. HAPC’s only occurred after the administration of bisacodyl in every patient. Finally, patients with major LARS displayed significantly less HAPC’s that started in the proximal colon and ended in the mid-section of the colon, compared to patients with no/minor LARS."

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

De volgende inclusiecriteria werden gebruikt: (i) patiënten die een TME ondergingen voor rectumkanker en een herstel van transit hadden gedurende minstens 12 maanden (TME of sluiting van de ileostomie gebeurde maximaal 24 maanden voor inclusie), (ii) patiënten moesten ziektevrij zijn één jaar na de operatie (iii) patiënten die in staat waren om één volledige dag naar UH Leuven te komen.

Exclusion Criteria

Patiënten werden uitgesloten als ze: (i) een Hartmann-procedure, abdominoperineale excisie, transanale endoscopische microchirurgische resectie of sigmoïdresectie hadden ondergaan, (ii) vóór de operatie incontinent waren voor ontlasting, en (iii) al eerder een bekkenoperatie, bekkenbestraling of lage anterieure resectie hadden ondergaan om niet-kankerredenen.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Evaluation of the motor patterns characteristics and the discrepancy in occurrence of sequences in patients with major LARS versus patient with no or minor LARS.</p>

Secondary Outcome Measures

Name	Time	Method
<p>Description of the relation between colonic motor patterns and propulsion as well as description of the relation between colonic motor patterns and symptoms.</p>