Patient's Quality of Life and Functional Changes After Fistula Surgery

NCT06548724 | Recruiting

• 1 other identifier: MD.21.08.508
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational study that will monitor the effects of surgery for anal fistula on the patient quality of life using many valid questionnaires

Conditions

Anal Fistula

Keywords

quality of life; incontinence; preoperative; postoperative

Outcome Measures

Primary Outcomes (1)

• patient quality of life changes before and after surgery with QoLAF-Q

  To Evaluate the impact of the fistula surgery on quality of life , the range range between 14 points which means zero impact on the quality of life and 70 which is the highest impact of anal fistula on the quality of life functional aspect in form of incontinence and quality of life of the patient

  after 1 and 3 and 6 months

Secondary Outcomes (1)

• the validation of arabic translation of the quesionaire

  3 and 5 months

Interventions

assessment of quality of life before and after anal surgery OTHER

Preoperatively, the state of continence will be assessed using Wexner Incontinence Score (WIS) . Also, the basal state of quality of life (QoL) will be assessed using a validated disease-specific tool known as Quality of Life in patients with Anal Fistula Questionnaire (QoLAFQ) (Ferrer-Márquez et al., , faecal incontinence quality of life (FIQL) Surgical Techniques: The selection of surgical technique depends on the type of fistula , patient choice and commitment to guidelines . Follow-up Patients will be followed-up in the outpatient clinic weekly in the first month, then every two weeks in the second month, then at 3, and 6 months postoperatively. The continence state and QoL change will be assessed using QoLAF-Q and GIQLI 3 months and6 months postoperatively.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient who will be admitted in the General Surgery Department, Colorectal Surgery Unit at Mansura University hospital

You may qualify if:

• both genders
• Age :between 18-65 years
• cryptoglandular anal fistula
• need intervention

You may not qualify if:

• \- Patients with associated anorectal pathology (anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.)

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlyia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Elsayed, MSC

CONTACT

01005814872; Ahmedhos2011@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of general and Colorectal surgery

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: August 12, 2024
• Study Start: August 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

EG (1)