Incidence and Risk Factors for TSIH

NCT04410744 | Completed DMC

• 1 other identifier: TSIH INCIDENCE
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Incisional Hernia

Keywords

Incisional hernia; Port site; Trocar site; Risk factors; Incidence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Risk factors for TSIH

  5 minutes

Interventions

Ultrasonographic examination DIAGNOSTIC_TEST

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.

Also known as: Clinical examination

Eligibility Criteria

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

Study Population

All consecutive patients who underwent laparoscopic surgery

You may qualify if:

• Previous laparoscopic surgery
• Age ≥18 years
• Informed consent signed

You may not qualify if:

• Previous umbilical hernia repair
• Age \< 18 years
• Informed consent not signed
• Failure to attend the postoperative appointment

Sponsors & Collaborators

• Hospital de Mataró: lead

Related Publications (1)

• 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.

  PMID: 33317503 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ana Ciscar

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General and digestive surgery specialist

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: June 2, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 4, 2020

Record last verified: 2020-06