Trial · NCT04991688
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with LARS > 20 | At 3 months after injection | |
| Secondary | Compliance to treatment | At 3 months after injection | Proportion of patients receiving full injections, 10 injections of 20U of toxin. A total of 200U of BOTOX A will be injected |
| Secondary | Tolerance to treatment | At 3 months after injection | Number of patients with adverse events |
| Secondary | Functional outcome with LARS score | At 0, 1, 2, 3 and 6 months | The LARS questionnaire (Low Anterior Resection Syndrome) was the primary end-pointy and evaluate bowel function. Five questions regarding incontinence for flatus and liquid stools, frequency, clustering and urgency for defecation are taken into account. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points) |
| Secondary | Faecal incontinence with Wexner score | At 0, 1, 2, 3 and 6 months | The Wexner score assesses the importance of anal incontinence, it varies from 0 to 20, 20 corresponding to total incontinence |
| Secondary | Quality of life (QLQ C-30) | At 0, 1, 3 and 6 months | The scores of questionnaire QLQ C-30 will be examined The EORTC QLQ-C30 is a patients self-rating questionnaire that measures physical, role, social, emotional, and cognitive functions as well as overall QoL. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales. |
| Secondary | Quality of life (QLQ CR-29) | At 0, 1, 3 and 6 months | The scores of questionnaire QLQ CR-29 will be examined The EORTC QLQ-CR29 has five functional and 18 symptom scales. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales. |
| Secondary | Evaluation of Anxiety profil (STAI-Y : State-Trait Anxiety Inventory ) | At 0, 1, 3 and 6 months | For evaluation of Anxiety profil , the "state" instructions is used, which require participants to report how they feel "right now, at this moment," and the "trait" instruction, which ask them to indicate how they "generally"feel. . For each subscales, scores range from 10 to 40, with higher scores correlating with greater state or trait anxiety. |
| Secondary | Evaluation of manometry | At 0, 1, 3 and 6 months | Manometry will measure the pressure in mmHg of the ano-rectal passage, specifically pressures corresponding to the internal and external sphincter, and rectum. The resting pressure and squeeze pressure will be assessed. Sensitivity test to assess first sensation of gas, urge to defecate, and urgency will also be assessed. |
| Secondary | Evaluation of barostat | At 0, 1, 3 and 6 months | Barostat allows the measurement of rectal capacity (ml) and compliance (ml/mmHg). Compliance is a dynamic property of the rectum, calculated from a sigmoid curve of pressure vs volume created by a step wise incremental distention sequence of a balloon placed in the rectum. Compliance of the patient population (post TME surgery) can be compared to compliance of non-operated rectums from published data. The investigators anticipate that our patient population will have a less compliant neo-rectum and hope to see a difference after Botox-A injection |
| Secondary | Proportion of patients with LARS ≤ 20 | At 6 months | |
| Secondary | Correlation between LARS and physiologic tests | At 0, 1, 2, 3 and 6 months | The correlation of objective physiologic measures such as manometry and barostat will be compared and correlated to the symptoms described by the patient in the LARS questionnaire before and after injection of Botox-A in the neo-rectum.The investigators anticipate a correlation of increased compliance in the neo rectum with improvement of symptoms (lower LARS score) post Botox-A injection |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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