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Perianal Abscess clinical trials

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NCT ID: NCT05990569 Recruiting - Hemorrhoids Clinical Trials

Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

Start date: August 12, 2023
Phase: N/A
Study type: Interventional

Study Description: The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone. Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups: 1. Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue. 2. Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone. The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue. Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention. Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale. By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.

NCT ID: NCT05862129 Not yet recruiting - Perianal Abscess Clinical Trials

Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S rDNA Amplicon Sequencing

Start date: May 10, 2023
Phase:
Study type: Observational

The goal of this observational study is tolearn the association of gut microflora with the onset of perianal abscesses. The main questions it aims to answer are: Question 1: To understand the structure of rectal microbial community composition and its relationship with pathogenic bacteria in patients with perianal abscess. Question 2: Understand the structure of rectal microbial community composition in healthy people. Participants will be collected with rectal secretions and stool specimens.In addition, patients with perianal abscess should also collect pus samples.

NCT ID: NCT05529628 Completed - Perianal Abscess Clinical Trials

The Immunological Differences Between Fournier Gangrene and Perianal Abscess

Start date: January 1, 2022
Phase:
Study type: Observational

Although it is rarely observed, necrotizing fasciitis progresses with high mortality and serious complications. Fournier's gangrene is a specific form of necrotizing fasciitis. In laboratory tests, leukocytosis or leukopenia, anemia, lymphopenia can be observed. Perianal abscess is a surgical emergency that is observed much more frequently than necrotizing fasciitis. Although Fournier's gangrene has many different etiologies, it rarely occurs due to the progression of perianal abscess, and although it is difficult to distinguish between these two diseases at diagnosis, the two diseases manifest themselves as different entities. In this study, blood cytokine levels will be evaluated in patients with Fournier's gangrene and perianal abscess, and the role of blood cytokine levels in the differential diagnosis of these two diseases will be investigated.

NCT ID: NCT05385887 Recruiting - Perianal Fistula Clinical Trials

Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial

ATLAS
Start date: December 23, 2021
Phase: N/A
Study type: Interventional

Rationale: Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\ Objective: The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas. Study design: The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality. Study population: Men and women of 18 years and older who present for the first time with a perianal abscess. Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets. Main study parameters/endpoints: Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.

NCT ID: NCT05193032 Completed - Perianal Abscess Clinical Trials

Abces After Incision: Recurrence or Not?

ABCINCIS
Start date: March 18, 2022
Phase:
Study type: Observational

The French School of Proctology assumes that any anal or perianal abscess is related to an anal fistula and therefore requires treatment at the risk of recurrence of the abscess. The Anglo-Saxons, on the other hand, recommend a simple incision in case of a first abscess, without taking care of the possible fistula, on the grounds that more than 60% of patients will not have a recurrence of their abscess. In addition, predictive factors of abscess recurrence have been reported such as female gender, age over 40 years, however, contradicted by other studies. High BMI, corticosteroid use, Crohn's disease are other predictive factors of recurrence while diabetes mellitus or antibiotic therapy during the days following the incision were considered as "protective". The objective of this study was to evaluate our experience in the hospital with essentially a description of the evolution of the patients in the 2 years following the incision of the abscess in consultation. The main objective is to describe the evolution of patients, within 2 years, who consulted our center for an anal or perianal abscess treated by a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.

NCT ID: NCT04832529 Completed - Perianal Abscess Clinical Trials

A Perianal Abscess Cavity Packing vs no Packing.

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started. Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.

NCT ID: NCT04549311 Active, not recruiting - Perianal Fistula Clinical Trials

Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial

PARFAIT
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

Most perianal abscesses (PA) result from an infection originating in anal crypts that extend into anal glands in the intersphincteric plane. Patients commonly present to the ER and usually require surgical intervention, which poses a burden on the healthcare system. If left undrained, a PA can expand into the adjacent tissues as well as progress to systemic infection. One of the major complications of PA are perianal fistulae; the creation of a tract between the anal canal and the perianal skin that is lined with granulation tissue or skin cells. Up to 1/3 of patients with a PA will develop a fistula; which occurs if a PA drains spontaneously through the perianal skin, and the infection becomes chronic. If this happens, surgical intervention is needed and abscesses may reoccur. Post incision and drainage (I&D) antibiotics in PA have been used to address complications but their use is still controversial and there are no specific recommendations on their use to prevent the formations of fistulae. Recent findings from a systematic review (6 studies, N=817 patients) published in 2019 demonstrated that antibiotic use following I&D of PA was associated with a 36% lower odds of fistula formation, though the quality of the evidence was low. As there are no established prophylactic treatments for fistulae, and because they are difficult to treat, further study of this simple intervention seems warranted. In this trial, adults with a PA requiring I&D will be randomly assigned to receive standard of care with antibiotics or standard of care without antibiotics after I&D. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest are incidence of fistula formation (defined as drainage of the perianal region at or after 2 months), need for re-intervention (i.e., any intervention on the perianal region), quality of life, healthcare utilization, healing time and mortality.

NCT ID: NCT03315169 Completed - Perianal Abscess Clinical Trials

Packing of Perianal Abscess Cavities

PPAC2
Start date: February 14, 2018
Phase: N/A
Study type: Interventional

The aim of this trial is to compare internal wound packing to no packing in postoperative management following incision and drainage of perianal abscess. Participants will be randomised 1:1 to either the packing or non-packing arm.

NCT ID: NCT02410707 Completed - Abscess Clinical Trials

Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults

Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.

NCT ID: NCT02306382 Recruiting - Incontinence Clinical Trials

Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Start date: December 2012
Phase: N/A
Study type: Interventional

Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence. Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal. The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.