The rationale of this study was to investigate the alteration of colonic motor patterns in the early postoperative stage and between patients with no or minor LARS-symptoms (LARS-score < 30) compared to patients experiencing major LARS…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Health condition
rectal cancer, low anterior resection syndrome, LARS, fecal incontinence, fecal urgency, frequency, fragmented defecation, soiling, bowel symptoms
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
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.
Secondary outcome
Description of the relation between colonic motor patterns and propulsion as well as description of the relation between colonic motor patterns and symptoms.
Background summary
Survival rates after rectal cancer and oncological outcomes have improved significantly over the years. Improved imaging, neoadjuvant therapy and standardized surgery all add to an improved oncological outcome. Radical surgery - a total mesorectal excision (TME) - remains the gold standard treatment. Because of the excision of the rectum, the rectal reservoir as such is lost. As a consequence, a low anterior resection - although nerve- and sphincter sparing - may result in debilitating functional consequences concerning bowel function. These bowel symptoms are commonly referred to as the Low Anterior Resection Syndrome (LARS); a complex syndrome consisting of a multitude of possible bowel symptoms, with consequences for the patient’s quality of life.
Notwithstanding the overwhelming use of ‘LARS’ as a term to describe these bowel symptoms (such as: incontinence for flatus or feces, frequent bowel movements, urgency and clustering of defecation), the exact pathophysiological mechanisms still remain poorly understood. It is hypothesized that the etiology of LARS is multifactorial, and relates to neo-rectal capacity and compliance, sphincter function, pelvic floor function, colonic motility and postprandial response. Based on these hypotheses, first it was explored if the creation of a rectal neo-reservoir would prevent LARS. However, evidence shows that a rectal neo-reservoir does not contribute to long term differences concerning bowel complaints, questioning its contribution to LARS/postoperative bowel function. However, the creation of a neo-rectum has been suggested to delay motility patterns; i.e. when stool reached the rectum, a delay of defecation was observed. Second, it has been demonstrated that, along with TME, a high ligation of the inferior mesenteric artery and the inferior mesenteric vein at the inferior border of the pancreas, could result in altered colonic motility and consequently affect postoperative function (LARS) due to autonomic denervation. To our knowledge, the impact of the mechanisms associated with radical surgery on colonic motility has only been scarcely investigated. Therefore, the innovative technique of high-resolution colon manometry (HRCM) can provide valuable insights into colonic motility patterns. Recently, a consensus statement on terminology and definitions of these patterns was published, giving an overview of the current knowledge. A recent study of Keane et al. using HRCM, demonstrated that in patients who underwent distal colorectal resection (on average 6.8 years before), LARS was associated with altered colonic motility.
Study objective
The rationale of this study was to investigate the alteration of colonic motor patterns in the early postoperative stage and between patients with no or minor LARS-symptoms (LARS-score < 30) compared to patients experiencing major LARS complaints (LARS-score ≥ 30). Consequently, the aim of this study was to investigate colonic motor patterns with HRCM and to assess the effect of hindgut denervation on the presence of coordinated proximal to distal contractions in rectal cancer patients suffering from varying degrees of LARS after TME.
Study design
The morning after an overnight fast of no less than 12 h, subjectswere expected at the endoscopy unit of the University Hospitals of Leuven. Loperamide hydrochloride was discontinued for 1 day. Bowel preparation consisted of one- liter of water enemas (Moviprep) at two timepoints the day before the HRCM. The colonoscopy was performed under conscious sedation (up to 5 mg midazolam). A high-resolution manometry (HRM) catheter (10- F solid state catheter containing 40 pressure sensors spaced 2.5 cm apart, Unisensor AG,) was clipped into the mucosa of the caecum. Two hours later, subjectswere positioned in a semi-recumbent pose on a bed and colonic pres-sure recordings started for 3 h. The subject subsequently received a standardized meal, based on the habitual Belgian lunch, and the re-cording of colonic pressures continued for two more hours. At this point, bisacodyl (10 mg) was administered intraluminally, thereafter,pressure recording continued for a maximum of 1 h. When the meas-urement was finished, the HRM was removed with a gentle pull.
Intervention
High resolution colon manometry
Age
Inclusion criteria
(i) patients who had a LAR, with TME for rectal cancer, (ii) patients have to be disease-free at time of inclusion (minimally 10 months after surgery) (iii) patients who are able to come to UZ Gasthuisberg (UZ-GHB) for one complete day
Exclusion criteria
(i) had a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgical resection, or sigmoid resection, (ii) were incontinent for feces before surgery, and (iii) already had previous pelvic surgery, previous pelvic radiation or LAR for non-cancer reasons
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7737 |
Other | the Ethical Committee of the University Hospitals of Leuven : S61398 |
Summary results
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."