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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04599517
Other study ID # HSU Konya HPRC General Surgery
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2020
Est. completion date December 15, 2020

Study information

Verified date January 2021
Source Konya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases that had undergone surgical treatment for SPD in the last 15 years in four different tertiary Stage hospitals and analyze the most frequently used surgical treatment method and its results.


Description:

The researchers in our study will retrospectively scan the records of patients who have been operated on for SPD in the last 15 years at Health Sciences University Konya Health Practice and Research Center, Selçuk University Medical Faculty Hospital, Necmettin Erbakan University Medical Faculty Hospital, and Başkent University Medical Faculty Hospital General Surgery Clinics. Demographic characteristics of the patients, type of anesthesia, duration of operation, duration of hospitalization, time to return to work or school, final healing time, follow-up time, and recurrence information will be transferred to the SPSS statistics program analyzed. The researchers could not find any articles in the literature on the subject. Therefore, this study will contribute to the literature.


Recruitment information / eligibility

Status Completed
Enrollment 6748
Est. completion date December 15, 2020
Est. primary completion date November 25, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 80 Years
Eligibility Inclusion Criteria: - All patients between the ages of 14-80 who underwent surgery for pilonidal sinus Exclusion Criteria: - unregulated diabetes mellitus - collagen tissue disease - decompensated cardiovascular disease - cases with missing follow-up information

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Konya Training and Research Hospital Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Hull TL, Wu J. Pilonidal disease. Surg Clin North Am. 2002 Dec;82(6):1169-85. Review. — View Citation

Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. — View Citation

Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnüriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Type of surgery method The ratio of each type of surgery to the study population 15 day
Primary duration of surgery The average operation time of the determined types of surgery will be determined. 15 day
Primary hospitalization time The average hospitalization time of the determined types of surgery will be determined. 15 day
Primary Type of anesthesia the ratio of anesthesia methods to the study population 15 day
Primary day time return to work return to work time will be found as average days for specified surgery types. 15 days
Primary complete healing time Complete healing time will be found as average days for specified surgery types 15 days
Primary recurrence recurrence rate in the study population 15 days
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