An interventional study of ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN) and CONTROL in Anal Fistula and Anal Abscess, sponsored by Germans Trias i Pujol Hospital. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Germans Trias i Pujol Hospital · Not applicable, Interventional, and Treatment
Among 12 studies in Rectal Fistula with a site in Spain — 1 open to participants now, 1 under way, none of them phase 3. Rectal Fistula · Spain.
Among the 12 studies in Rectal Fistula with a site in Spain, this one is one of 2 that started in 2022, is one of 4 with no phase, and was the 6th registered.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 210 is above the median of 66 across 115 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →1 of the 12 studies in Rectal Fistula with a site in Spain is open now, in 1 country. Each count lists the studies.
Of the 26 Rectal Fistula studies recruiting now, 18 (69%) set no upper age limit and 7 (27%) stop at 75 or younger; 2 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2022.
Median enrollment 50 across the 9 interventional studies, 32 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
5 of 12 have an industry lead sponsor. The 10 most frequent:
Germans Trias i Pujol Hospital is the lead sponsor of 89 studies on the registry; 12 are open to participants now.
Germans Trias i Pujol Hospital has 1 study filed under Rectal Fistula — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Rectal Fistula with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. There is clinical evidence that the origin of most perianal fistulas (60%) is with an episode one year before of a perianal abscess. In fact, the established cryptoglandular hypothesis considered the origin of anal fistula, a chronic infectious disease starting on a clinical episode of an anal glands abscess. However, controversy exists regarding the role of antibiotics in the development of anal fistula after incision and drainage of perianal abscess. Nowadays, only two single-centre randomized controlled trials has been published addressing this issue, with inconclusive results. The MAIN OBJECTIVE of the study is to examine the clinical benefit of antibiotic therapy in patients with a perianal abscess, to avoid the development of a perianal fistula. METHODOLOGY We designed a prospective, multicentre double-blind placebo trial to analyse the clinical benefit of a course of antibiotics after perianal abscess drainage to diminish the probability of development of perianal fistula in the follow up of patients. Patients with anal abscess will be allocated randomly either to receive 7 days of oral metronidazole/ciprofloxacin in addition to their standard care or to receive standard care and placebo, after they will be discharged from the hospital. Patients will be followed clinically at different intervals during one year in order to know if they develop anal fistula. Also a quality of life assessment at the end of the study will be evaluated. EXPECTED RESULTS We expected that patients allocated to antibiotic treatment would develop a significant less anal fistulas in their follow-up with a related significant better quality of life. Thus, a change on standard of care led by our group, may be achieved.
METHODS This project is a 3-year study.
Trial Design:
This is a multicentre, double-blind placebo trial to investigate the effect of oral antibiotics after anal abscess drainage to diminish the development of an anal fistul.
This Clinical Trial will consist of two parallel study groups with a (1:1) randomization, masking by double-blind technique and placebo control.
Participants:
The participants of this study will be eligible among those who will be attended on the emergency department of each participant hospital during inclusion period.
Interventions:
This study will include patients who come to the emergency room due to perianal abscesses and who will be incised and drained of the lesion by local anaesthesia (in emergency boxes) or by regional or general anaesthesia (in the operating room). A standard procedure will be followed with draining the purulent contents and then instilling a solution composed of saline and iodine through the wound; as well as manual exploration and lysis of intracavity septa.
In all cases as it it standardized, the wound will be left open with insinuated gauze or a latex drainage (Penrose) when necessary.
The patients, once selected, will be randomly distributed (by specific software) in two parallel groups, in one of which the intervention will be evaluated. In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days. The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
Postoperative controls and follow-up will be carried out at 1, 3, 6 and 12 months after treatment and will include an endoanal ultrasound (US) at 6 months.
Studied variables:
The following variables will be analysed:
The diagnosis of anal fistula is standarized by specialist in General Surgery.
Expected outcomes:
Once the patients with diagnosis of perianal abscess treated with incision and drainage were included, the objective of our study will be to evaluate the proportion of patients who developed perianal fistula between the two study groups (with oral antibiotics and with placebo). It will be recorded as the presence of a perianal fistula when the participants present a history of symptoms compatible with it, as well as the existence of a communication between the perianal cutaneous tissue and the anal canal during the clinical examination performed or even evidenced in the endoanal ultrasound during the controls that will be carried out up to 12 months after the intervention. For better evaluation and registration abscesses will be classified according to their complexity: subcutaneous, intersphincteric, ischiorectal and according to their anatomical location: anterior, posterior, lateral, right and left. These data will be collected at the time of the surgical exploration during the initial treatment with incision and drainage.
Fistulas will be classified by Parks classification in the following: subcutaneous, intersphinterian, transphincteric, suprasphinteric, extraphincteric. These data will be collected at the time of the clinical examination during the controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
Other: CONTROL
In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days.
Drug: ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN) · Other: CONTROL
The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
NO treatment
Perianal fistula incidence
Formation of perianal/anal fistula at follow-up during 12 months after anal abscess. This outcome will be defined clinically and with anal ultrasound.
Time frame: 12 months
Improving on Quality of life
Measurement of quality of life. We will use the test named SF36 in its Validated version in Spanish. This test evaluates the health-related quality of life with answers of 36 questions and punctuates from 0 to 100, being 100 the maximum score (Better quality of life).
Time frame: 12 months
Ran from Mar 2022 to primary completion in Mar 2022, 0 months.
Of 53 non-industry interventional studies with no phase under Rectal Fistula, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's 0 months is below that.
Counting every sponsor, half of 57 studies reached it within 27 months; a quarter within 11 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Germans Trias i Pujol Hospital