Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias

This study has been completed.
Sponsor:
Information provided by:
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT01240434
First received: November 12, 2010
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

The investigators perform a simple-blind randomized trial with two groups, one in which all the orifices are closed by suturing the external fascia of the abdominal wall (Group A), and another in which the orifices are left open, closing only the skin (Group B). Monitoring for trocar site hernia lasted 2 years from the intervention.


Condition Intervention
The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH)
in Orifices Created by Trocars Measuring ≥10 mm in Diameter,
and to Determine Whether Closure of the External Fascial Layer Prevents
TSH and Potential Related Complications.
Procedure: Trocar site closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Estudio Prospectivo Aleatorizado Simple Ciego Sobre la Incidencia de Hernias Incisionales en Los Orificios de Los trócares de Laparoscopia: Cierre aponeurótico Superficial Frente a cicatrización aponeurótica Sin Cierre

Resource links provided by NLM:


Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • The incidence of trocar site hernia [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of wound infections [ Designated as safety issue: No ]
    The secondary outcome measure try to relation surgical wound infection with surgical wound closure of the fascia and the incidence of trocar site hernia


Enrollment: 195
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fascia closure of the surgical trocars
Arm in which all the surgical trocar orifices are closed by suturing the external fascia of the abdominal wall with a number 1 monofilament absorbable suture (Polydioxanone)
Procedure: Trocar site closure
The study has 2 arms: one in which all the ST orifices are closed by suturing the external fascia of the abdominal wall with a number 1 monofilament absorbable suture (Polydioxanone) (Group A), and another in which all the orifices of the ST are left open, closing only the skin (Group B).
No Intervention: Trocar site without closure
All the orifices of the trocar site are left open, closing only the skin.
Procedure: Trocar site closure
The study has 2 arms: one in which all the ST orifices are closed by suturing the external fascia of the abdominal wall with a number 1 monofilament absorbable suture (Polydioxanone) (Group A), and another in which all the orifices of the ST are left open, closing only the skin (Group B).

Detailed Description:

This is a single-blind trial including all patients undergoing laparoscopic surgery performed by the same surgical team (5 surgeons) and for whom at least one "study trocar" (ST) id use. STs is define as blunt-tip trocars that are inserted blind, had a diameter of 11 mm or 12 mm, and are not enlarged during surgery. The investigators have not studied the Hasson trocar, as the defect it creates is surgeon-dependent and not uniform.

The investigators exclude patients presenting factors that affect the scarring process, such as malnutrition (serum proteins <5 g/dl), advanced cancer, perioperative hemodynamic instability, or prolonged treatment with corticosteroids. Orifices that are enlarged for specimen extraction are also excluded, although other orifices in the same patient are included.

The investigators exclude the following patients: those who are converted to open surgery, those who underwent a second intervention with an open technique during the early postoperative period, or those who are lost to follow-up. Patients who hace not an ST after surgery (mostly patients with only one ST that have to be enlarged for specimen extraction) are excluded from the trial.

The investigators randomize patients using a random table from Excel® for Windows XP®.

The trocars that the investigators use are Endopath Xcel (Ethicon Endo-Surgery, Puerto Rico, USA), which are 11 mm and 12 mm in diameter.

The study has 2 arms: one in which all the ST orifices are closed by suturing the external fascia of the abdominal wall with a number 1 monofilament absorbable suture (Polydioxanone) (Group A), and another in which all the orifices of the ST are left open, closing only the skin (Group B).

This trial has been approved by the corresponding ethics committee. All the patients signe their informed consent to participate in the trial before randomization.

Follow-up involve 2 postoperative contacts for each patient, the first during the first year after the operation, and the second 2 years after the intervention. These contacts are made by phone, and the patient is asked about any lumps or discomfort in the scar area. A positive answer is followed by an appointment for a detailed examination and, if necessary an abdominal ultrasound scan.

Demographics, diagnosis, and surgical technique is analyzed for each patient, as is hospital stay, morbidity, and the number of trocars and STs used with their size and location.

For the topographic analysis, the investigators divide the abdomen in 7 areas according to the different fascial layers of the abdominal wall (Figure 1).

The statistical analysis is performed using SPSS 11.5 for Windows.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All the patients undergoing laparoscopic surgery performed by the same surgical team (5 surgeons) and for whom at least one "study trocar" (ST) is used. STs is defined as blunt-tip trocars that are inserted blind, had a diameter of 11 mm or 12 mm, and are not enlarged during surgery.

Exclusion Criteria:

Hasson trocar Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins <5 g/dl), advanced cancer, perioperative hemodynamic instability, or prolonged treatment with corticosteroids. Orifices that are enlarged for specimen extraction are also excluded, although other orifices in the same patient are included.

Patients who are converted to open surgery. Patients who did not have an ST after surgery (mostly patients with only one ST that had to be enlarged for specimen extraction) were excluded from the trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240434

Locations
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
  More Information

No publications provided by Hospital General Universitario Gregorio Marañon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesús Lago Oliver, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT01240434     History of Changes
Other Study ID Numbers: cierrlaparosc001
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica-Área 1

Keywords provided by Hospital General Universitario Gregorio Marañon:
trocar hernia closure laparoscopy

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014