Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-28 @ 10:40 PM
Study NCT ID:
NCT01240434
Status:
COMPLETED
Last Update Posted:
2010-11-15
First Post:
2010-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias
Sponsor:
Hospital General Universitario Gregorio Marañon
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: