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

November 12, 2010
November 12, 2010
March 2006
September 2007   (final data collection date for primary outcome measure)
The incidence of trocar site hernia [ Designated as safety issue: No ]
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • 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
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).
  • 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)
    Intervention: Procedure: Trocar site closure
  • No Intervention: Trocar site without closure
    All the orifices of the trocar site are left open, closing only the skin.
    Intervention: Procedure: Trocar site closure
Lago J, Serralta D, García A, Martín J, Sanz M, Pérez MD, Turégano F. Randomized prospective trial on the occurrence of laparoscopic trocar site hernias. J Laparoendosc Adv Surg Tech A. 2011 Nov;21(9):775-9. doi: 10.1089/lap.2011.0262.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
October 2008
September 2007   (final data collection date for primary outcome measure)

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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01240434
cierrlaparosc001
No
Jesús Lago Oliver, Hospital General Universitario Gregorio Marañon
Hospital General Universitario Gregorio Marañon
Not Provided
Not Provided
Hospital General Universitario Gregorio Marañon
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP