Incidence and Risk Factors for TSIH (TSIHi)

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

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia
• Intervention / Treatment: Diagnostic test: Ultrasonographic examination

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 76

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who underwent laparoscopic surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical TSIH incidence	Presence / absence palpableTSIH (yes / not)	30 seconds
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for TSIH	Risk factors for TSIH determination. Information obtained from the electronic medical record	5 minutes

Collaborators and Investigators

• Sponsor: Hospital de Mataró
• Investigators: Principal Investigator: Ana Ciscar, Hospital de Mataro

Publications and helpful links

General Publications

• Ciscar A, Badia JM, Novell F, Bolivar S, Mans E. Incidence and risk factors for trocar-site incisional hernia detected by clinical and ultrasound examination: a prospective observational study. BMC Surg. 2020 Dec 14;20(1):330. doi: 10.1186/s12893-020-01000-6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2015
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (ACTUAL): June 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Incidence; Risk factors; Incisional hernia; Port site; Trocar site
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: TSIH INCIDENCE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No