Anal FissureNCT04428697
Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique
A study testing Sungurtekin Technique in people with Anal Fissure, run by Pamukkale University.
Trial summary
BACKGROUND: Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure. However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Sungurtekin Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with CAFs that had failed conservative therapy and required surgical treatment
- -
Who cannot join
- Patients who have a low resting anal pressure in manometric study (lower than 40 mmHg)
- Recurrent anal fissure
- Fissure location other than the posterior anal canal
- Fissure due to inflammatory bowel or infectious disease
- Acute anal fissure,
- Fissure due to chronic diarrhea or anal stenosis
Show all 12Show fewer
- Anorectal malignancy
- Patients undergone pelvic radiotherapy
- Pregnancy
- Patients with history of diabetes, neurological disease and spinal cord lesions
- Previous episiotomy history
- Painless fissures
About this study
Official title: Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano: A Prospective, Randomized, Controlled Trial of a New Technique
BACKGROUND: Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure. However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence.
OBJECTIVE: To compare a new ultra-modified internal sphincterotomy technique to the closed lateral sphincterotomy for treating chronic anal fissures, based on internal anal sphincter function and postoperative complications.
Read more
DESIGN: Prospective, randomized, controlled trial (block randomization method) SETTING: Pamukkale University hospital in Denizli-Turkey PARTICIPANTS: 200 patients with chronic anal fissures INTERVENTION: Patients were randomly assigned to receive either Sungurtekin technique (n = 100; ultra-modified group), or the closed lateral internal sphincterotomy (n = 100; closed-lateral group). Follow-up was 2 years.
MAIN OUTCOME MEASURES: The primary outcome was chronic anal fissure healing. The secondary outcomes were complications, visual analog scale pain scores, sphincter pressures, and incontinence scores.
Read the detailed description
Although the lateral internal sphincterotomy is the treatment of choice for CAF, it has several drawbacks. First, the lower portion of the internal sphincter is nested in the lowermost part of the anus. Thus, an incision from the fissure base up to the dentate line removes support to the inner sphincter structure on the incision site. In our opinion; this is the main cause of different levels of incontinence developing in the postoperative period. Second, the internal sphincter muscle is shorter in women than in men. Therefore, women are at higher risk of postoperative anal incontinence than men. Third, because the lateral internal sphincterotomy is not standardized, the length of the internal sphincter incision varies, depending on the surgeon's discretion and competency. Fourth, an incision that is too short increases in the risk of recurrence.
The investigators believe that this observation could be explained by the fact that the length of the incision required for a lateral internal sphincterotomy procedure has not been standardized
- Conditions
- Anal Fissure
- Being tested
- Sungurtekin Technique
- Keywords
- Fissure-in-ano, Sphincterotomy, İncontinence, Surgical technique
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sungurtekin TechniqueProcedure or surgery
Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter cut with cautery .
| Study group | Role | What they receive |
|---|---|---|
| Sungurtekin Technique | Experimental | Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm. After identifying both the internal and external sphincters completely, under direct vision, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. This section was preserved during the operation in a standard fashion for all patients . Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter bundle was elevated with a right angle clamp, then cut with cautery . The operation was completed with meticulous hemostasis and additional suturing (3/0 absorbable suture) of the proximally dissected mucosal flap underlying the muscularis layer Receives: Procedure: Sungurtekin Technique |
| Closed Lateral Internal Sphincterotomy | Active comparator | The sphincterotomy was performed through a new incision, guided by the surgeon's finger, as described by Boulos et al Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? The British journal of surgery 1984;71:360-2. Receives: Procedure: Sungurtekin Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
It has been reported in the literature that healing was completed in 6-8 weeks in patients undergoing this operation. During this period, it was accepted that the fissure was no longer detected as a visual examination finding and that patient complaints disappeared.
Measured: 1-24 month
Postoperatif pain
The patients asked to record postoperative pain scores with VAS(Visual Analog Scale)Graded from 0.0 to 10.0. and measured postoperative day 3 .As low as possible this pain score value indicates that the patient is exposed to less pain.
Measured: Postopetaive 3th day
Incontinence Rate
Pre and postoperative fecal continence were scored using the Cleveland Clinic Florida Fecal Incontinence (CCF-FI) scores. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 12 months. The scores from 0 indicate perfect continence to a maximum of 20 indicates complete incontinence The CCF FI scale combines loss of flatus, liquid and solid stool, use of a pad and the impact on the quality of life a assess the severity of fecal incontinence.
Measured: 12th month
Complications
Urinary retansion,ecchymosis,itching,bleeding,abscess,fistula has been accepted as postoperative complications
Measured: 1-24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 May 2013
- Primary completion1 May 2020
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Anal FissureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hulya Sungurtekin, Pamukkale University
- Investigators
- Ugur Sungurtekin, MD, Study director, Pamukkale University Department Of Surgery,Colorectal Surgery Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428697
- Sponsor's protocol ID
- Sungurtekin 01
- Status last verified
- Jun 2020
- First submitted
- 22 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tocchi A, Mazzoni G, Miccini M, Cassini D, Bettelli E, Brozzetti S. Total lateral sphincterotomy for anal fissure. Int J Colorectal Dis. 2004 May;19(3):245-9. doi: 10.1007/s00384-003-0525-9. Epub 2003 Sep 9.
PubMed 13680282Gandomkar H, Zeinoddini A, Heidari R, Amoli HA. Partial lateral internal sphincterotomy versus combined botulinum toxin A injection and topical diltiazem in the treatment of chronic anal fissure: a randomized clinical trial. Dis Colon Rectum. 2015 Feb;58(2):228-34. doi: 10.1097/DCR.0000000000000307.
PubMed 25585082Salih AM. Chronic anal fissures: Open lateral internal sphincterotomy result; a case series study. Ann Med Surg (Lond). 2017 Feb 14;15:56-58. doi: 10.1016/j.amsu.2017.02.005. eCollection 2017 Mar.
PubMed 28239456Liang J, Church JM. Lateral internal sphincterotomy for surgically recurrent chronic anal fissure. Am J Surg. 2015 Oct;210(4):715-9. doi: 10.1016/j.amjsurg.2015.05.005. Epub 2015 Jun 27.
PubMed 26231724Wiley M, Day P, Rieger N, Stephens J, Moore J. Open vs. closed lateral internal sphincterotomy for idiopathic fissure-in-ano: a prospective, randomized, controlled trial. Dis Colon Rectum. 2004 Jun;47(6):847-52. doi: 10.1007/s10350-004-0530-2. Epub 2004 May 6.
PubMed 15129311Gupta V, Rodrigues G, Prabhu R, Ravi C. Open versus closed lateral internal anal sphincterotomy in the management of chronic anal fissures: a prospective randomized study. Asian J Surg. 2014 Oct;37(4):178-83. doi: 10.1016/j.asjsur.2014.01.009. Epub 2014 Mar 14.
PubMed 24637183Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19.
PubMed 29779044Mentes BB, Guner MK, Leventoglu S, Akyurek N. Fine-tuning of the extent of lateral internal sphincterotomy: spasm-controlled vs. up to the fissure apex. Dis Colon Rectum. 2008 Jan;51(1):128-33. doi: 10.1007/s10350-007-9121-3. Epub 2007 Dec 18.
PubMed 18085337Murad-Regadas SM, Fernandes GO, Regadas FS, Rodrigues LV, Pereira Jde J, Regadas Filho FS, Dealcanfreitas ID, Holanda Ede C. How much of the internal sphincter may be divided during lateral sphincterotomy for chronic anal fissure in women? Morphologic and functional evaluation after sphincterotomy. Dis Colon Rectum. 2013 May;56(5):645-51. doi: 10.1097/DCR.0b013e31827a7416.
PubMed 23575405Tsunoda A, Takahashi T, Kusanagi H. Fissurectomy with vertical non-full-thickness sphincterotomy for chronic anal fissure. Tech Coloproctol. 2019 Oct;23(10):1009-1013. doi: 10.1007/s10151-019-02087-7. Epub 2019 Sep 24. No abstract available.
PubMed 31552509Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
PubMed 8416784Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? Br J Surg. 1984 May;71(5):360-2. doi: 10.1002/bjs.1800710517.
PubMed 6722464Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.
PubMed 27926552Cross KL, Massey EJ, Fowler AL, Monson JR; ACPGBI. The management of anal fissure: ACPGBI position statement. Colorectal Dis. 2008 Nov;10 Suppl 3:1-7. doi: 10.1111/j.1463-1318.2008.01681.x. No abstract available.
PubMed 18954306Brady JT, Althans AR, Neupane R, Dosokey EMG, Jabir MA, Reynolds HL, Steele SR, Stein SL. Treatment for anal fissure: Is there a safe option? Am J Surg. 2017 Oct;214(4):623-628. doi: 10.1016/j.amjsurg.2017.06.004. Epub 2017 Jul 5.
PubMed 28701263
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano: A Prospective, Randomized, Controlled Trial of a New Technique
- ClinicalTrials.gov ID
- NCT04428697
- Acronym / sponsor ID
- Sungurtekin 01
- Conditions
- Anal Fissure
- Keywords
- Fissure-in-ano, Sphincterotomy, İncontinence, Surgical technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 11 Jun 2020 (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.
BACKGROUND: Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure. However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence.
OBJECTIVE: To compare a new ultra-modified internal sphincterotomy technique to the closed lateral sphincterotomy for treating chronic anal fissures, based on internal anal sphincter function and postoperative complications.
DESIGN: Prospective, randomized, controlled trial (block randomization method) SETTING: Pamukkale University hospital in Denizli-Turkey PARTICIPANTS: 200 patients with chronic anal fissures INTERVENTION: Patients were randomly assigned to receive either Sungurtekin technique (n = 100; ultra-modified group), or the closed lateral internal sphincterotomy (n = 100; closed-lateral group). Follow-up was 2 years.
MAIN OUTCOME MEASURES: The primary outcome was chronic anal fissure healing. The secondary outcomes were complications, visual analog scale pain scores, sphincter pressures, and incontinence scores.
Detailed description
Although the lateral internal sphincterotomy is the treatment of choice for CAF, it has several drawbacks. First, the lower portion of the internal sphincter is nested in the lowermost part of the anus. Thus, an incision from the fissure base up to the dentate line removes support to the inner sphincter structure on the incision site. In our opinion; this is the main cause of different levels of incontinence developing in the postoperative period. Second, the internal sphincter muscle is shorter in women than in men. Therefore, women are at higher risk of postoperative anal incontinence than men. Third, because the lateral internal sphincterotomy is not standardized, the length of the internal sphincter incision varies, depending on the surgeon's discretion and competency. Fourth, an incision that is too short increases in the risk of recurrence.
The investigators believe that this observation could be explained by the fact that the length of the incision required for a lateral internal sphincterotomy procedure has not been standardized
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sungurtekin Technique | Experimental | Procedure: Sungurtekin TechniqueSungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm. After identifying both the internal and external sphincters completely, under direct vision, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. This section was preserved during the operation in a standard fashion for all patients . Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter bundle was elevated with a right angle clamp, then cut with cautery . The operation was completed with meticulous hemostasis and additional suturing (3/0 absorbable suture) of the proximally dissected mucosal flap underlying the muscularis layer |
| Closed Lateral Internal Sphincterotomy | Active comparator | Procedure: Sungurtekin TechniqueThe sphincterotomy was performed through a new incision, guided by the surgeon's finger, as described by Boulos et al Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? The British journal of surgery 1984;71:360-2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with CAFs that had failed conservative therapy and required surgical treatment
- -
Key exclusion criteria (12 listed)
- Patients who have a low resting anal pressure in manometric study (lower than 40 mmHg)
- Recurrent anal fissure
- Fissure location other than the posterior anal canal
- Fissure due to inflammatory bowel or infectious disease
- Acute anal fissure,
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 |
|---|---|---|
| Sungurtekin TechniqueSungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter cut with cautery . | Procedure or surgery | Closed Lateral Internal Sphincterotomy, Sungurtekin Technique |
Primary outcome
Recurrence
Time frame: 1-24 month
It has been reported in the literature that healing was completed in 6-8 weeks in patients undergoing this operation. During this period, it was accepted that the fissure was no longer detected as a visual examination finding and that patient complaints disappeared.
Postoperatif pain
Time frame: Postopetaive 3th day
The patients asked to record postoperative pain scores with VAS(Visual Analog Scale)Graded from 0.0 to 10.0. and measured postoperative day 3 .As low as possible this pain score value indicates that the patient is exposed to less pain.
Incontinence Rate
Time frame: 12th month
Pre and postoperative fecal continence were scored using the Cleveland Clinic Florida Fecal Incontinence (CCF-FI) scores. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 12 months. The scores from 0 indicate perfect continence to a maximum of 20 indicates complete incontinence The CCF FI scale combines loss of flatus, liquid and solid stool, use of a pad and the impact on the quality of life a assess the severity of fecal incontinence.
Complications
Time frame: 1-24 month
Urinary retansion,ecchymosis,itching,bleeding,abscess,fistula has been accepted as postoperative complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Results publication: PubMed 13680282Tocchi A, Mazzoni G, Miccini M, Cassini D, Bettelli E, Brozzetti S. Total lateral sphincterotomy for anal fissure. Int J Colorectal Dis. 2004 May;19(3):245-9. doi: 10.1007/s00384-003-0525-9. Epub 2003 Sep 9.
- Results publication: PubMed 25585082Gandomkar H, Zeinoddini A, Heidari R, Amoli HA. Partial lateral internal sphincterotomy versus combined botulinum toxin A injection and topical diltiazem in the treatment of chronic anal fissure: a randomized clinical trial. Dis Colon Rectum. 2015 Feb;58(2):228-34. doi: 10.1097/DCR.0000000000000307.
- Results publication: PubMed 28239456Salih AM. Chronic anal fissures: Open lateral internal sphincterotomy result; a case series study. Ann Med Surg (Lond). 2017 Feb 14;15:56-58. doi: 10.1016/j.amsu.2017.02.005. eCollection 2017 Mar.
- Results publication: PubMed 26231724Liang J, Church JM. Lateral internal sphincterotomy for surgically recurrent chronic anal fissure. Am J Surg. 2015 Oct;210(4):715-9. doi: 10.1016/j.amjsurg.2015.05.005. Epub 2015 Jun 27.
- Results publication: PubMed 15129311Wiley M, Day P, Rieger N, Stephens J, Moore J. Open vs. closed lateral internal sphincterotomy for idiopathic fissure-in-ano: a prospective, randomized, controlled trial. Dis Colon Rectum. 2004 Jun;47(6):847-52. doi: 10.1007/s10350-004-0530-2. Epub 2004 May 6.
- Results publication: PubMed 24637183Gupta V, Rodrigues G, Prabhu R, Ravi C. Open versus closed lateral internal anal sphincterotomy in the management of chronic anal fissures: a prospective randomized study. Asian J Surg. 2014 Oct;37(4):178-83. doi: 10.1016/j.asjsur.2014.01.009. Epub 2014 Mar 14.
- Results publication: PubMed 29779044Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19.
- Results publication: PubMed 18085337Mentes BB, Guner MK, Leventoglu S, Akyurek N. Fine-tuning of the extent of lateral internal sphincterotomy: spasm-controlled vs. up to the fissure apex. Dis Colon Rectum. 2008 Jan;51(1):128-33. doi: 10.1007/s10350-007-9121-3. Epub 2007 Dec 18.
- Results publication: PubMed 23575405Murad-Regadas SM, Fernandes GO, Regadas FS, Rodrigues LV, Pereira Jde J, Regadas Filho FS, Dealcanfreitas ID, Holanda Ede C. How much of the internal sphincter may be divided during lateral sphincterotomy for chronic anal fissure in women? Morphologic and functional evaluation after sphincterotomy. Dis Colon Rectum. 2013 May;56(5):645-51. doi: 10.1097/DCR.0b013e31827a7416.
- Results publication: PubMed 31552509Tsunoda A, Takahashi T, Kusanagi H. Fissurectomy with vertical non-full-thickness sphincterotomy for chronic anal fissure. Tech Coloproctol. 2019 Oct;23(10):1009-1013. doi: 10.1007/s10151-019-02087-7. Epub 2019 Sep 24. No abstract available.
- Results publication: PubMed 8416784Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
- Results publication: PubMed 6722464Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? Br J Surg. 1984 May;71(5):360-2. doi: 10.1002/bjs.1800710517.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ugur Sungurtekin, MD study director
Pamukkale University Department Of Surgery,Colorectal Surgery Division
Questions about this trial
What is this clinical trial studying?
A study testing Sungurtekin Technique in people with Anal Fissure, run by Pamukkale University.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 1-24 month). The study lists 4 primary outcomes in all. 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 NCT04428697, which also lists 25 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 11 Jun 2020.