Anal FistulaPLEN-SPARENCT07897539
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
A study testing Mechanical bowel preparation in people with Anal Fistula and Rectal Fistula, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to learn whether bowel preparation with Plenvu before surgery improves healing of complex anal fistula in adults aged 18 to 64 years with a fistula of cryptoglandular origin or associated with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anal Fistula, Rectal Fistula, Crohn Disease
- What is being tested?
- Mechanical bowel preparation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 64 years
- Complex anal fistula of cryptoglandular origin or associated with Crohn's disease
- Fistula suitable for repair with ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian) or endorectal advancement flap
- Patients with or without previous attempts at fistula closure
- Signed written informed consent
Who cannot join
- Patients aged < 18 years.
- Pregnant patients.
- Fistulae with aetiologies other than cryptoglandular or Crohn's disease.
- Complex fistulae associated with cavities and/or secondary tracts.
- Patients with fistulae who underwent faecal diversion before fistula surgery.
- Patients with ASA classification of IV or higher.
- Patients with severe conditions such as renal failure that predisposes to dehydration or hydroelectrolytic disorders.
- Patients who have previously experienced allergic reactions to NER1006 or any of its chemical components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ursula A. Fält, MD, PhD contact
Sweden1 site
Skane University Hospital, Pelvic Floor Centre
Malmö, Skåne County, 214 28
Victor J Verwaal, Associate Professor of Surgery, +46 40333019, victor.verwaal@med.lu.se
Mikael Ekelund, Associate Professor of Surgery, +46 46171896, mikael.ekelund@skane.se
About this study
Official title: Colon Cleansing Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
The goal of this clinical trial is to learn whether bowel preparation with Plenvu before surgery improves healing of complex anal fistula in adults aged 18 to 64 years with a fistula of cryptoglandular origin or associated with Crohn's disease.
The main question it aims to answer is:
Read more
- Does bowel preparation before surgery increase the proportion of participants whose fistula is clinically healed 6 months after surgery?
Researchers will compare participants who prepare the bowel before surgery with participants who receive no bowel preparation. All participants receive the same oral antibiotic regimen and one of three standard sphincter-preserving operations: ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian), or endorectal advancement flap. The operation is chosen individually by the surgeon as the most appropriate for each fistula, before randomisation.
Participants will:
- Be randomly assigned to bowel preparation or no bowel preparation
- Undergo one fistula operation within the study
- Attend follow-up visits 6 and 12 months after surgery, including clinical examination and 3D endoanal ultrasound at 12 months after surgery
- Complete questionnaires on anal continence and quality of life
Read the detailed description
Background Surgery for anal fistula aims to close the fistula while preserving continence, and healing rates after sphincter-preserving techniques vary widely. Current guidelines (ESCP 2024) give no recommendation on bowel preparation before anal fistula surgery, and no randomised evidence exists on its effect on fistula healing. The hypothesis is that emptying the bowel before surgery delays the first postoperative bowel movement and reduces faecal contamination of, and mechanical strain on, the repair during early healing.
Design Single-centre, open-label, randomised controlled trial with two parallel arms and 1:1 allocation. The surgical technique (LIFT, autologous platelet-rich fibrin [Obsidian] or endorectal advancement flap) is chosen individually by the surgeon as the most appropriate for each fistula, and documented before randomisation. Allocation is computer-generated using permuted blocks stratified by surgical technique. Each participant undergoes one fistula operation within the study.
Interventions Experimental arm: mechanical bowel preparation with Plenvu, two doses taken the evening before surgery. Control arm: no bowel preparation. Both arms receive a single oral dose of trimethoprim/sulfamethoxazole 160/800 mg and a single oral dose of metronidazole 1.2 g before surgery, and otherwise identical perioperative care.
Follow-up Participants are assessed at baseline and at 6 and 12 months after surgery. Baseline data include age, sex, height, weight, body mass index, smoking, diabetes, cardiovascular, pulmonary, renal and chronic inflammatory disease, albumin, haemoglobin, C-reactive protein, ongoing immunosuppressive treatment, fistula aetiology, Parks classification and previous fistula surgery. For participants with Crohn's disease, the Montreal classification and the Perianal Disease Activity Index (PDAI) are recorded.
Blinding Participants and surgeons are not blinded. Clinical healing is assessed by the surgical team, who are aware of allocation.
Sample size A total of 116 participants (58 per arm) is planned to detect an absolute difference of 25 percentage points in clinical healing at 6 months, with an alpha of 0.05 and a power of 80%, allowing for 10% loss to follow-up.
Statistical analysis Dichotomous Variables (Healing Rates): The overall proportion of healed patients between groups will be compared using a Chi-square test. A multivariable logistic regression model will be used to adjust for the surgery type stratum. The treatment effect will be reported as an odds ratio (OR) alongside 95% confidence intervals.
Continuous Variables (Score Changes): Changes in continuous scores from baseline will be evaluated using a multiple linear regression model. The model will compare the mean differences between the two treatment groups while adjusting for baseline scores and the stratum of the surgery type. If the assumptions of linear regression are strictly violated, appropriate data transformations or nonparametric alternatives will be applied.
Missing data: To strictly adhere to the intention-to-treat (ITT) principle, all randomised participants will be included in the final analysis in their originally assigned groups. To handle missing data, Multiple Imputation (MI) may be utilised as the primary analytical approach, but a complete case analysis will also be conducted. The imputation model would include the stratification variable (surgery type), baseline scores, and available intermediate follow-up data.
- Conditions
- Anal Fistula, Rectal Fistula, Crohn Disease
- Being tested
- Mechanical bowel preparation
- Keywords
- mechanical bowel preparation, fistula-in-ano, LIFT, endorectal advancement flap, platelet-rich fibrin, endoanal ultrasound
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical bowel preparationProcedure or surgery
Oral bowel cleansing with Plenvu before surgery used within its marketing authorisation.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Bowel preparation | Experimental | Mechanical bowel preparation with Plenvu before surgery. All participants receive the same oral antibiotic regimen. Participants then undergo LIFT, platelet-rich fibrin (Obsidian) or endorectal advancement flap, chosen individually for each fistula before randomisation. Receives: Procedure: Mechanical bowel preparation |
| No bowel preparation | No intervention | No preoperative bowel preparation. All participants receive the same oral antibiotic regimen. Participants then undergo LIFT, platelet-rich fibrin (Obsidian) or endorectal advancement flap, chosen individually for each fistula before randomisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Healing Rate at 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).
Measured: 6 months post-surgery
Secondary outcomes (6)
Fistula Healing Rate at 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).
Measured: 12 Months Post-Surgery
Radiological Fistula Healing Rate on 3D Endoanal Ultrasound at 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.
Measured: 12 Months Post-Surgery
Change in St Mark's Incontinence Score
St Mark's (Vaizey) incontinence score, range 0-24; higher scores indicate worse incontinence.
Measured: Baseline, 6 and 12 months post-surgery
Postoperative Complications Measured by the Comprehensive Complication Index (CCI)
CCI summarises all complications graded by Clavien-Dindo; range 0-100, higher scores indicate more severe cumulative morbidity.
Measured: 30 days after surgery
Change in Quality of Life Measured by the QoLAF-Q
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.
Measured: Baseline, at 6 and 12 months post-surgery
Change in Perianal Disease Activity Index (PDAI) in Participants With Crohn's Disease
PDAI, range 0-20; higher scores indicate more active perianal disease.
Measured: Baseline, 6 and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomised trial with 1:1 allocation, stratified by surgical technique (LIFT, platelet-rich fibrin, endorectal advancement flap) decided before randomisation.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olof Grip, MD, PhD, associate professor, Principal investigator, Department of gastroenterology. Skane University Hospital. Malmö. Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897539
- Sponsor's protocol ID
- Dnr 2026-03367-01
- Acronym
- PLEN-SPARE
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research group, as the ethical approval and participant consent do not cover such sharing under the GDPR and Swedish law.
Publications
Ferrer-Marquez M, Espinola-Cortes N, Reina-Duarte A, Granero-Molina J, Fernandez-Sola C, Hernandez-Padilla JM. Design and Psychometric Evaluation of the Quality of Life in Patients With Anal Fistula Questionnaire. Dis Colon Rectum. 2017 Oct;60(10):1083-1091. doi: 10.1097/DCR.0000000000000877.
PubMed 28891853Aguilera-Castro L, Ferre-Aracil C, Garcia-Garcia-de-Paredes A, Rodriguez-de-Santiago E, Lopez-Sanroman A. Management of complex perianal Crohn's disease. Ann Gastroenterol. 2017;30(1):33-44. doi: 10.20524/aog.2016.0099. Epub 2016 Oct 27.
PubMed 28042236Lusilla Lopez A, Falt UA, Buchwald P, Johnson LB, Grip O. Platelet-rich fibrin matrix as treatment for complex anal fistulae: A 3-year experience at a tertiary centre. Colorectal Dis. 2026 Apr;28(4):e70447. doi: 10.1111/codi.70447.
PubMed 41932840Maya I, Spada E, Marti-Gallostra M, Cirera de Tudela A, Pellino G, Espin-Basany E. Long-term outcomes of a bioactive matrix enriched with an autologous platelet concentrate for the treatment of complex anal fistulae. Tech Coloproctol. 2025 Mar 5;29(1):73. doi: 10.1007/s10151-024-03102-2.
PubMed 40044989Rollins KE, Javanmard-Emamghissi H, Acheson AG, Lobo DN. The Role of Oral Antibiotic Preparation in Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2019 Jul;270(1):43-58. doi: 10.1097/SLA.0000000000003145.
PubMed 30570543Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
PubMed 36748942Tan J, Ryan EJ, Davey MG, McHugh FT, Creavin B, Whelan MC, Kelly ME, Neary PC, Kavanagh DO, O'Riordan JM. Mechanical bowel preparation and antibiotics in elective colorectal surgery: network meta-analysis. BJS Open. 2023 May 5;7(3):zrad040. doi: 10.1093/bjsopen/zrad040.
PubMed 37257059Reza L, Gottgens K, Kleijnen J, Breukink S, Ambe PC, Aigner F, Aytac E, Bislenghi G, Nordholm-Carstensen A, Elfeki H, Gallo G, Grossi U, Gulcu B, Iqbal N, Jimenez-Rodriguez R, Leventoglu S, Lisi G, Litta F, Lung P, Millan M, Ozturk E, Sackitey C, Shalaby M, Stijns J, Tozer P, Zimmerman D. European Society of Coloproctology: Guidelines for diagnosis and treatment of cryptoglandular anal fistula. Colorectal Dis. 2024 Jan;26(1):145-196. doi: 10.1111/codi.16741. Epub 2023 Dec 5.
PubMed 38050857
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Cleansing Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
- ClinicalTrials.gov ID
- NCT07897539
- Acronym / sponsor ID
- PLEN-SPARE / Dnr 2026-03367-01
- Conditions
- Anal Fistula, Rectal Fistula, Crohn Disease
- Keywords
- mechanical bowel preparation, fistula-in-ano, LIFT, endorectal advancement flap, platelet-rich fibrin, endoanal ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether bowel preparation with Plenvu before surgery improves healing of complex anal fistula in adults aged 18 to 64 years with a fistula of cryptoglandular origin or associated with Crohn's disease.
The main question it aims to answer is:
- Does bowel preparation before surgery increase the proportion of participants whose fistula is clinically healed 6 months after surgery?
Researchers will compare participants who prepare the bowel before surgery with participants who receive no bowel preparation. All participants receive the same oral antibiotic regimen and one of three standard sphincter-preserving operations: ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian), or endorectal advancement flap. The operation is chosen individually by the surgeon as the most appropriate for each fistula, before randomisation.
Participants will:
- Be randomly assigned to bowel preparation or no bowel preparation
- Undergo one fistula operation within the study
- Attend follow-up visits 6 and 12 months after surgery, including clinical examination and 3D endoanal ultrasound at 12 months after surgery
- Complete questionnaires on anal continence and quality of life
Detailed description
Background Surgery for anal fistula aims to close the fistula while preserving continence, and healing rates after sphincter-preserving techniques vary widely. Current guidelines (ESCP 2024) give no recommendation on bowel preparation before anal fistula surgery, and no randomised evidence exists on its effect on fistula healing. The hypothesis is that emptying the bowel before surgery delays the first postoperative bowel movement and reduces faecal contamination of, and mechanical strain on, the repair during early healing.
Design Single-centre, open-label, randomised controlled trial with two parallel arms and 1:1 allocation. The surgical technique (LIFT, autologous platelet-rich fibrin [Obsidian] or endorectal advancement flap) is chosen individually by the surgeon as the most appropriate for each fistula, and documented before randomisation. Allocation is computer-generated using permuted blocks stratified by surgical technique. Each participant undergoes one fistula operation within the study.
Interventions Experimental arm: mechanical bowel preparation with Plenvu, two doses taken the evening before surgery. Control arm: no bowel preparation. Both arms receive a single oral dose of trimethoprim/sulfamethoxazole 160/800 mg and a single oral dose of metronidazole 1.2 g before surgery, and otherwise identical perioperative care.
Follow-up Participants are assessed at baseline and at 6 and 12 months after surgery. Baseline data include age, sex, height, weight, body mass index, smoking, diabetes, cardiovascular, pulmonary, renal and chronic inflammatory disease, albumin, haemoglobin, C-reactive protein, ongoing immunosuppressive treatment, fistula aetiology, Parks classification and previous fistula surgery. For participants with Crohn's disease, the Montreal classification and the Perianal Disease Activity Index (PDAI) are recorded.
Blinding Participants and surgeons are not blinded. Clinical healing is assessed by the surgical team, who are aware of allocation.
Sample size A total of 116 participants (58 per arm) is planned to detect an absolute difference of 25 percentage points in clinical healing at 6 months, with an alpha of 0.05 and a power of 80%, allowing for 10% loss to follow-up.
Statistical analysis Dichotomous Variables (Healing Rates): The overall proportion of healed patients between groups will be compared using a Chi-square test. A multivariable logistic regression model will be used to adjust for the surgery type stratum. The treatment effect will be reported as an odds ratio (OR) alongside 95% confidence intervals.
Continuous Variables (Score Changes): Changes in continuous scores from baseline will be evaluated using a multiple linear regression model. The model will compare the mean differences between the two treatment groups while adjusting for baseline scores and the stratum of the surgery type. If the assumptions of linear regression are strictly violated, appropriate data transformations or nonparametric alternatives will be applied.
Missing data: To strictly adhere to the intention-to-treat (ITT) principle, all randomised participants will be included in the final analysis in their originally assigned groups. To handle missing data, Multiple Imputation (MI) may be utilised as the primary analytical approach, but a complete case analysis will also be conducted. The imputation model would include the stratification variable (surgery type), baseline scores, and available intermediate follow-up data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomised trial with 1:1 allocation, stratified by surgical technique (LIFT, platelet-rich fibrin, endorectal advancement flap) decided before randomisation.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Bowel preparation | Experimental | Procedure: Mechanical bowel preparationMechanical bowel preparation with Plenvu before surgery. All participants receive the same oral antibiotic regimen. Participants then undergo LIFT, platelet-rich fibrin (Obsidian) or endorectal advancement flap, chosen individually for each fistula before randomisation. |
| No bowel preparation | No intervention | –No preoperative bowel preparation. All participants receive the same oral antibiotic regimen. Participants then undergo LIFT, platelet-rich fibrin (Obsidian) or endorectal advancement flap, chosen individually for each fistula before randomisation. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 64 years
- Complex anal fistula of cryptoglandular origin or associated with Crohn's disease
- Fistula suitable for repair with ligation of the intersphincteric fistula tract (LIFT), autologous platelet-rich fibrin (Obsidian) or endorectal advancement flap
- Patients with or without previous attempts at fistula closure
- Signed written informed consent
Key exclusion criteria (8 listed)
- Patients aged < 18 years.
- Pregnant patients.
- Fistulae with aetiologies other than cryptoglandular or Crohn's disease.
- Complex fistulae associated with cavities and/or secondary tracts.
- Patients with fistulae who underwent faecal diversion before fistula surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical bowel preparationOral bowel cleansing with Plenvu before surgery used within its marketing authorisation. | Procedure or surgery | Mechanical Bowel preparation |
Primary outcome
Fistula Healing Rate at 6 Months Post-Surgery
Time frame: 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).
6 secondary outcomes
Fistula Healing Rate at 12 Months Post-Surgery
Time frame: 12 Months Post-Surgery
Radiological Fistula Healing Rate on 3D Endoanal Ultrasound at 12 Months Post-Surgery
Time frame: 12 Months Post-Surgery
Change in St Mark's Incontinence Score
Time frame: Baseline, 6 and 12 months post-surgery
Postoperative Complications Measured by the Comprehensive Complication Index (CCI)
Time frame: 30 days after surgery
Change in Quality of Life Measured by the QoLAF-Q
Time frame: Baseline, at 6 and 12 months post-surgery
Change in Perianal Disease Activity Index (PDAI) in Participants With Crohn's Disease
Time frame: Baseline, 6 and 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 28891853Ferrer-Marquez M, Espinola-Cortes N, Reina-Duarte A, Granero-Molina J, Fernandez-Sola C, Hernandez-Padilla JM. Design and Psychometric Evaluation of the Quality of Life in Patients With Anal Fistula Questionnaire. Dis Colon Rectum. 2017 Oct;60(10):1083-1091. doi: 10.1097/DCR.0000000000000877.
- Background: PubMed 28042236Aguilera-Castro L, Ferre-Aracil C, Garcia-Garcia-de-Paredes A, Rodriguez-de-Santiago E, Lopez-Sanroman A. Management of complex perianal Crohn's disease. Ann Gastroenterol. 2017;30(1):33-44. doi: 10.20524/aog.2016.0099. Epub 2016 Oct 27.
- Background: PubMed 41932840Lusilla Lopez A, Falt UA, Buchwald P, Johnson LB, Grip O. Platelet-rich fibrin matrix as treatment for complex anal fistulae: A 3-year experience at a tertiary centre. Colorectal Dis. 2026 Apr;28(4):e70447. doi: 10.1111/codi.70447.
- Background: PubMed 40044989Maya I, Spada E, Marti-Gallostra M, Cirera de Tudela A, Pellino G, Espin-Basany E. Long-term outcomes of a bioactive matrix enriched with an autologous platelet concentrate for the treatment of complex anal fistulae. Tech Coloproctol. 2025 Mar 5;29(1):73. doi: 10.1007/s10151-024-03102-2.
- Background: PubMed 30570543Rollins KE, Javanmard-Emamghissi H, Acheson AG, Lobo DN. The Role of Oral Antibiotic Preparation in Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2019 Jul;270(1):43-58. doi: 10.1097/SLA.0000000000003145.
- Background: PubMed 36748942Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
- Background: PubMed 37257059Tan J, Ryan EJ, Davey MG, McHugh FT, Creavin B, Whelan MC, Kelly ME, Neary PC, Kavanagh DO, O'Riordan JM. Mechanical bowel preparation and antibiotics in elective colorectal surgery: network meta-analysis. BJS Open. 2023 May 5;7(3):zrad040. doi: 10.1093/bjsopen/zrad040.
- Background: PubMed 38050857Reza L, Gottgens K, Kleijnen J, Breukink S, Ambe PC, Aigner F, Aytac E, Bislenghi G, Nordholm-Carstensen A, Elfeki H, Gallo G, Grossi U, Gulcu B, Iqbal N, Jimenez-Rodriguez R, Leventoglu S, Lisi G, Litta F, Lung P, Millan M, Ozturk E, Sackitey C, Shalaby M, Stijns J, Tozer P, Zimmerman D. European Society of Coloproctology: Guidelines for diagnosis and treatment of cryptoglandular anal fistula. Colorectal Dis. 2024 Jan;26(1):145-196. doi: 10.1111/codi.16741. Epub 2023 Dec 5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research group, as the ethical approval and participant consent do not cover such sharing under the GDPR and Swedish law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ursula A. Fält, MD, PhD contact
Olof Grip, MD, PhD, associate professor principal investigator
Department of gastroenterology. Skane University Hospital. Malmö. Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical bowel preparation in people with Anal Fistula and Rectal Fistula, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Lusilla Lopez, MD (+4640331154, alejandro.lusilla_lopez@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula Healing Rate at 6 Months Post-Surgery (time frame: 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07897539, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.