Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias
Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias
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.
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.