Incidence and Risk Factors for TSIH

Incisional Hernia Clinical Trial

— TSIHi  

Official title:

Incidence and Risk Factors for Trocar Site Incisional Hernia Detected by Clinical and Ultrasonographic Examination.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410744
• Other study ID #: TSIH INCIDENCE
• Status: Completed
• Start date: June 2, 2015
• Est. completion date: January 1, 2016

Study information

• Verified date: June 2020
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Trocar site incisional hernia (TSIH) is the most frequent complication associated to laparoscopic surgery. Few studies currently describes its real prevalence or risk factors. The aim of this study is to determine the real incidence of TSIH and to identify risk factors in the investigator's series of patients.

A cross sectional, prospective study is performed including consecutive patients who underwent a laparoscopic procedure during a four months period. All the patients are assessed both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the incidence of TSIH. A multivariate analysis is performed to identify risk factors.

Description:

Single-centre cross-sectional study based on prospective clinical and radiological assessment and retrospective risk factor analyses performed at a single hospital.

All consecutive patients who underwent laparoscopic surgery (cholecystectomy, colon resection, adrenalectomy, Nissen fundoplication and appendectomy) during a four months period were included in the study. At least 30 months after hospital discharge, they were invited by telephone to participate in the study. Detailed project information was provided, and those who accepted received an appointment for an outpatient visit and a dynamic ultrasound. Informed consent was obtained from all participants. In all patients, the umbilical trocar wound was closed with an interrupted suture with synthetic braided absorbable 2/0 suture (Novosyn® or Safil®). During the postoperative outpatient visit, clinical and ultrasonographic examinations were performed. To increase study homogeneity, all clinical examinations and ultrasounds were performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively. Sonography was performed with an Applio 500 equipment (Toshiba, Japan) with a 3.5MHz convex probe and a 7MHz linear probe. The ultrasound diagnosis was based on the identification of an abdominal wall defect with intraabdominal tissue protrusion. The main variables of the study were clinical (TSIHc) and ultrasound (TSIHu) diagnosis of incisional hernia. All results and variables were introduced in a previous specifically designed database (File MakerPro 11.0v3 © 1984-2011 FileMaker, Inc.). Data were collected from clinical interviews, physical and radiological examinations and the electronic medical record. Statistical analyses were performed using the SPSS statistical software (IBM SPSS® Statistics).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 1, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous laparoscopic surgery

• Age =18 years

• Informed consent signed

Exclusion Criteria:

• Previous umbilical hernia repair

• Age < 18 years

• Informed consent not signed

• Failure to attend the postoperative appointment

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Diagnostic Test:
• Ultrasonographic examination
All clinical examinations (physical exam) and ultrasounds are performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical TSIH incidence	Presence / absence palpableTSIH (yes / not)	30 seconds
Primary	ultrasonographic TSIH incidence	Identification of an abdominal wall defect with intraabdominal tissue protrusion (yes /not) Caudal and cranial diameters of the abdominal wall's defect (cm)	1 minute 30 seconds
Secondary	Risk factors for TSIH	Risk factors for TSIH determination. Information obtained from the electronic medical record	5 minutes