Oral B-Complex Vitamin (B6, B9 and B12) Prevents Low Anterior Resection Syndrome in Rectal Cancer Patients With Hyperhomocysteinemia
NCT07928180, Not applicable, Not yet recruiting, Qilu Hospital of Shandong University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Oral B-Complex Vitamin (B6, B9 and B12) Prevents Low Anterior Resection Syndrome in Rectal Cancer Patients With Hyperhomocysteinemia | ClinicalTrials.gov |
| NCT number | NCT07928180 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 277 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Qilu Hospital of Shandong University | ClinicalTrials.gov |
| Conditions | Low Anterior Resection Syndrome, Hyperhomocysteinemia, Rectal Cancer | ClinicalTrials.gov |
| Interventions | Oral B-Complex Vitamin (B6, B9 and B12), Placebo | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Low Anterior Resection Syndrome (LARS) | 6 months after surgery (3 months after stoma closure for participants whose protective stoma has not been closed by 6 months after surgery) | Proportion of participants with LARS, defined as a total score of 21 or higher on the LARS score questionnaire. The LARS score is a validated 5-item questionnaire on bowel function (Emmertsen and Laurberg, 2012), with a total score ranging from 0 to 42; higher scores indicate worse bowel function (0-20: no LARS; 21-29: minor LARS; 30-42: major LARS). | ClinicalTrials.gov |
| Secondary | LARS Score | 6 months after surgery (3 months after stoma closure for participants whose protective stoma has not been closed by 6 months after surgery) | Total LARS score (range 0-42; higher scores indicate worse bowel function), compared between groups as a continuous variable. | ClinicalTrials.gov |
| Secondary | Serum Homocysteine Concentration | Baseline (preoperative), and 3 and 6 months after surgery | Serum homocysteine concentration (μmol/L). | ClinicalTrials.gov |
| Secondary | Systolic Blood Pressure | 3 and 6 months after surgery | Systolic blood pressure (mmHg) measured in the seated position. | ClinicalTrials.gov |
| Secondary | Diastolic Blood Pressure | 3 and 6 months after surgery | Diastolic blood pressure (mmHg) measured in the seated position. | ClinicalTrials.gov |
| Secondary | Anal Resting Pressure | 3 and 6 months after surgery | Anal resting pressure (mmHg) measured by anorectal manometry. | ClinicalTrials.gov |
| Secondary | Maximum Anal Squeeze Pressure | 3 and 6 months after surgery | Maximum anal squeeze pressure (mmHg) measured by anorectal manometry. | ClinicalTrials.gov |
| Secondary | Presence of Rectoanal Inhibitory Reflex | 3 and 6 months after surgery | Proportion of participants with a present rectoanal inhibitory reflex on anorectal manometry. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)