The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH)NCT01240434
Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias
A study testing Trocar site closure in people with The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH) and in Orifices Created by Trocars Measuring ≥10 mm in Diameter,, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- 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
- What is being tested?
- Trocar site closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
About this study
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
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.
Read the 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.
- Being tested
- Trocar site closure
- Keywords
- trocar hernia closure laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trocar site closureProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Fascia closure of the surgical trocars | Active comparator | 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) Receives: Procedure: Trocar site closure |
| Trocar site without closure | No intervention | All the orifices of the trocar site are left open, closing only the skin. Receives: Procedure: Trocar site closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of trocar site hernia
Secondary outcomes (1)
The incidence of wound infections
The secondary outcome measure try to relation surgical wound infection with surgical wound closure of the fascia and the incidence of trocar site hernia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startMar 2006
- Primary completionSep 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240434
- Sponsor's protocol ID
- cierrlaparosc001
- Status last verified
- Mar 2006
- First submitted
- 12 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22050610
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01240434
- Acronym / sponsor ID
- cierrlaparosc001
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia closure of the surgical trocars | Active comparator | Procedure: Trocar site closureArm 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) |
| Trocar site without closure | No intervention | Procedure: Trocar site closureAll the orifices of the trocar site are left open, closing only the skin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trocar site closureThe 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). | Procedure or surgery | Fascia closure of the surgical trocars, Trocar site without closure |
Primary outcome
The incidence of trocar site hernia
1 secondary outcome
The incidence of wound infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- Derived from this study: PubMed 22050610Lago 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trocar site closure in people with The Aim of the Study is to Analyze the Incidence of Trocar Site Hernia (TSH) and in Orifices Created by Trocars Measuring ≥10 mm in Diameter,, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of trocar site hernia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.