Trial · NCT07897539
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
NCT07897539, Not applicable, Not yet recruiting, Region Skane
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae. Trials, record NCT07897539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897539
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
- NCT number
- NCT07897539
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 116 participants, estimated
- Lead sponsor
- Region Skane
- Conditions
- Anal Fistula, Rectal Fistula, Crohn Disease
- Interventions
- Mechanical bowel preparation
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fistula Healing Rate at 6 Months Post-Surgery | 6 months post-surgery | Percentage of participants with clinical fistula healing, defined as complete closure of the external opening with no discharge on clinical examination, assessed by the surgical team (not blinded to allocation). |
| Secondary | Fistula Healing Rate at 12 Months Post-Surgery | 12 Months Post-Surgery | Percentage of participants with clinical fistula healing, defined as complete closure of the external opening with no discharge on clinical examination, assessed by the surgical team (not blinded to allocation). |
| Secondary | Radiological Fistula Healing Rate on 3D Endoanal Ultrasound at 12 Months Post-Surgery | 12 Months Post-Surgery | Percentage of participants with radiological fistula healing on 3D endoanal ultrasound, defined as the replacement of the previous fistulous tract with homogeneous tissue of intermediate echogenicity. |
| Secondary | Change in St Mark's Incontinence Score | Baseline, 6 and 12 months post-surgery | St Mark's (Vaizey) incontinence score, range 0-24; higher scores indicate worse incontinence. |
| Secondary | Postoperative Complications Measured by the Comprehensive Complication Index (CCI) | 30 days after surgery | CCI summarises all complications graded by Clavien-Dindo; range 0-100, higher scores indicate more severe cumulative morbidity. |
| Secondary | Change in Quality of Life Measured by the QoLAF-Q | Baseline, at 6 and 12 months post-surgery | Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q): 14 items on a 5-point Likert scale, total score 14-70; higher scores indicate greater impact of the fistula on quality of life. |
| Secondary | Change in Perianal Disease Activity Index (PDAI) in Participants With Crohn's Disease | Baseline, 6 and 12 months post-surgery | PDAI, range 0-20; higher scores indicate more active perianal disease. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897539
GET https://conductscience.org/api/trials/v1/NCT07897539/registered