Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias

NCT ID: NCT01240434

Last Updated: 2010-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-10-31

Brief Summary

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.

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.

Conditions

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.

Keywords

trocar hernia closure laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Trocar site closure

Intervention Type: PROCEDURE

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).

Trocar site without closure

All the orifices of the trocar site are left open, closing only the skin.

Group Type: NO_INTERVENTION

Trocar site closure

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role: lead

Responsible Party

Hospital General Universitario Gregorio Marañon

Locations

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Countries

Spain

References

Lago J, Serralta D, Garcia A, Martin J, Sanz M, Perez MD, Turegano 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.

Reference Type: DERIVED

PMID: 22050610 (View on PubMed)

Other Identifiers

cierrlaparosc001

Identifier Type: -

Identifier Source: org_study_id