Clinical trials

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Condition / disease
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Status: Not yet recruiting

Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula

This prospective, single-center, self-controlled pilot cohort study evaluates whether loose seton biomaterial is associated with patient-reported outcomes in adults with recurrent or persistent complex cryptoglandular anal fistula. Participants with an existing polypropylene loose seton who require seton replacement as part of routine clinical management will be prospectively enrolled. The decision to replace the seton will be made by the treating colorectal surgeon independently of study participation. No seton replacement or additional surgical procedure will be performed solely for research purposes. Patient-reported outcomes will be assessed immediately before replacement while the polypropylene loose seton remains in place and will be reassessed at 4 and 12 weeks after replacement with a braided polyester loose seton. The primary outcome is the within-participant change in disease-specific quality of life measured using the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q). Secondary outcomes include perianal pain, anal continence, patient comfort, foreign-body awareness, hygiene burden, anal discharge, interference with daily activities, patient satisfaction, analgesic use, and treatment-related adverse events. The study uses a within-participant design in which each participant serves as their own control. As a pilot study, it will also evaluate recruitment, retention, questionnaire completion, protocol adherence, and outcome variability to inform the design of a future multicenter prospective study.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Acibadem Kent HospitalUpdated: Sep 14, 2026Locations: 1Duration: 12 Weeks
Eligibility criteria

Age 18 years or older [+6]

Anal fistula associated with Crohn's disease [+6]

Status: Not yet recruiting

Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC

Background: Fistula tract laser closure (FiLaC) has emerged as a sphincter-preserving treatment for anal fistula (AF). However, the optimal role of preoperative bowel preparation (BP) in enhancing postoperative outcomes remains contentious. While some surgeons recommend enemas to empty the rectum, others ignore BP altogether due to concerns about possible contamination from enemas. Current guidelines suggest that the decision to perform BP is at the surgeon's discretion, as it is not definitively linked to healing rates. Objective: This prospective, non-randomized observational cohort study aims to evaluate whether preoperative bowel preparation significantly impacts primary healing rates following FiLaC in patients with anal fistula. Methods: One hundred consecutive patients undergoing FiLaC will be prospectively enrolled and stratified into two cohorts: Group A (BP) and Group B (no BP). Anal fistulas will be classified by Parks classification. The primary outcome is complete clinical healing at three months, defined by the absence of discharge, an epithelialized external opening, and no recurrence. Secondary outcomes include six-month healing rates, recurrence, postoperative pain, quality of life, Wexner continence scores, and complication rates. Multivariate logistic regression will be employed to control for potential confounders, including smoking status, prior seton use, and fistula complexity. Discussion: This study aims to fill the evidence gap regarding the benefits of preoperative BP in FiLaC procedures, improving perioperative protocols to optimize healing outcomes while reducing unnecessary interventions. The findings will provide clinicians with evidence-based guidance on BP strategies.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Acibadem Kent HospitalUpdated: Sep 2, 2026Duration: 6 Months
Eligibility criteria

Age ≥18 years [+3]

Fistula associated with Crohn's disease, tuberculosis, or malignancy [+4]

Status: Available

Comparison of the Effects of Vaginal Cuff Closure Sexual Function in Laparoscopic Hysterectomy

Aim: Laparoscopic hysterectomy is the vaginal removal of the uterus with the help of laparoscopy. After the uterus is removed after hysterectomy, vaginal length is shortened by cuff suturing, resulting in conditions such as dyspareunia and sexual dysfunction . Hysterectomy may also affect women physically and psychologically, as well as causing changes in sexual functions . In patients planned to undergo hysterectomy; Changes that may occur in sexual functions cause serious concerns during the preoperative period. However, physicians often miss these important points and do not discuss these issues adequately with patients. In this study; We aimed to compare the effects of vaginal cuff closure techniques in laparoscopic hysterectomy on vaginal length and women's sexual life. We used the Arizona Sexual Experience Scale to assess women's sexual life.

Trial details
Age: 18-65Biological sex: FemaleType: Expanded AccessSponsor: Acibadem Kent HospitalUpdated: Nov 14, 2025Locations: 1
Eligibility criteria

Perimenopausal period [+3]

Uterus size greater than 14 weeks' gestation [+6]