Hernia, VentralNCT00532870
Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh Repair
A study testing laparoscopic in people with Hernia, Ventral, run by Mansoura University at 2 sites in Egypt.
Trial summary
The laparoscopic repair of ventral hernias is still a controversial therapeutic option. To evaluate the efficacy and safety of laparoscopic repair we compare the results of the open and laparoscopic repair of ventral hernia,. 53 patients were undergo laparoscopic or open repair of ventral hernia . Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- laparoscopic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesEgypt
- Study dates
- Mar 2003to Dec 2004
- 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 30 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient aged over 30 years
- Medical fitness for general anesthesia
- The absence of coagulopathy, and hernial defect ≥ 5 cm in any dimension or recurrent hernias.
Who cannot join
- Neoplastic patients
- Immune compromised patients
- Mentally incompetent patients; and
- Those who refused to give signed consents.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35511
Study site
Al Mansurah
About this study
The laparoscopic repair of ventral hernias is still a controversial therapeutic option. To evaluate the efficacy and safety of laparoscopic repair we compare the results of the open and laparoscopic repair of ventral hernia,. 53 patients were undergo laparoscopic or open repair of ventral hernia . All defects were estimated to be larger than 5 cm in diameter. Twenty six patients underwent attempted laparoscopic ventral hernia repair (LVHR) with mesh and twenty seven patients underwent open ventral hernia repair (OVHR) with mesh
Read the detailed description
Between March 2003 and December 2004, 53 patients (16 males and 37 females) with ventral hernias were treated by a laparoscopic or open approach. Patients were divided into two groups: one group underwent laparoscopic repair with GORE-TEX Dual Mesh, and the other group underwent open repair with proline mesh. Informed written consents were obtained from all patients.
Inclusion criteria involved any patient aged over 30 years, medical fitness for general anesthesia, the absence of coagulopathy, and hernial defect ≥ 5 cm in any dimension or recurrent hernias. Exclusion criteria were neoplastic patients, immune compromised patients, mentally incompetent patients and those who refused to give signed consents.
Demographic features, operative details and postoperative outcomes were collected prospectively and included patient age, gender, body mass index (BMI) (weight in kg/height in m2), number of prior abdominal operations, number of previous hernia repairs, technique of repair, size of facial defect, type of prosthetic mesh, operating time, conversion rate, length of hospital stay, operative and postoperative complications, and hernia recurrences.
Thirty-seven patients presented with an incisional hernia (12 upper midline, 15 lower midline, and 10 transverse abdominal), 8 had an epigastric hernia, 8 had an periumbilical hernia, . All defects were estimated to be larger than 5 cm in diameter.
Standard bowel preparation was undertaken for every patient on the day before the operation. Prophylactic short-term antibiotic therapy with a one gram of third-generation cephalosporin was also administered routinely two hours before the operation. Nasogastric suction and bladder catheterization were used routinely during the operation only. All operations were performed under general anesthesia; Open mesh repair was done as described else where (9, 10).
Operative Procedure of laparoscopic ventral hernia repair:
pneumoperitoneum was established by using a Verses needle. The initial entry site was usually just inferior to the tip of the eleventh rib to establish a 15 mmHg pneumoperitoneum for exploration of the abdomen. One 10-mm trocar and three to five 5-mm trocars were then placed outside the perimeter of the hernia. Adhesiolysis was performed to free the anterior abdominal wall and identify the hernia defect. The peritoneal sac was not reduced and the mesh was placed in an intraabdominal position.
The mesh was prepared to extend 3 to 5 cm beyond the hernia defect. Four anchoring sutures were placed in the corners of the mesh, which was then introduced into the abdomen via a 10-mm port. The sutures were secured across the full thickness of the abdominal wall with the use of a laparoscopic suture passer. A laparoscopic mesh stapler device was used to place 5-mm spiral staples at 1-cm intervals around the mesh edge. . No drains were placed.
Postoperative management intravenous analgesia was administered postoperatively. All patients were encouraged to move as soon as possible. Postoperatively, the severity of pain was assessed daily by a visual analogue scale (VAS) on a scale from 0 (no pain) to 10 (worst pain). Upon discharge, all patients were taught to complete a pain score chart at home for daily documentation of pain score at rest and on coughing.
Follow up at the surgical Clinic was scheduled at 1 week, 8 weeks and 1 and 2 years after operation for assessment of postoperative complications: seromas (collection of fluid persisting > 4 weeks or causing local discomfort), hematomas, infection, abdominal wall pain, bowel obstruction, recurrences, aesthetic evaluation. The pain score charts were collected by the surgeon at the surgical clinic. All complications were recorded and clinical recurrence was documented during follow up.
Also, the outcome evaluation was measured by the duration of return to activity, pain free return to activity, return to work and pain free return to work.
Statistical analysis Variables measured on a nominal scale were analyzed in the form of 2 x K tables and Fisher's exact test when appropriate. Variables measured on an ordinal scale were analyzed by kruskal Wallis test. All tests were two tailed and made at a level of significance of < 0.05.
- Conditions
- Hernia, Ventral
- Being tested
- laparoscopic
- Keywords
- laparoscopy, ventral hernia, mesh, Ventral hernias are the second most common type of abdominal hernias after inguinal hernias., The majority of ventral hernias are incisional hernias that develop in 11% to 20% of patients who undergo Laparotomy ., Surgeons have struggled to reduce the morbidity from incarceration (6% to 15% of cases) and strangulation (2%) of these hernias.
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopicOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | laparoscopy Receives: Other: laparoscopic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startMar 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- tarek mahdy, md, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532870
- Sponsor's protocol ID
- mfms1861964
- Status last verified
- Sep 2007
- First submitted
- 20 Sep 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh Repair
- ClinicalTrials.gov ID
- NCT00532870
- Acronym / sponsor ID
- mfms1861964
- Conditions
- Hernia, Ventral
- Keywords
- laparoscopy, ventral hernia, mesh, Ventral hernias are the second most common type of abdominal hernias after inguinal hernias., The majority of ventral hernias are incisional hernias that develop in 11% to 20% of patients who undergo Laparotomy ., Surgeons have struggled to reduce the morbidity from incarceration (6% to 15% of cases) and strangulation (2%) of these hernias.
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Dec 2004 (actual)
- First posted
- 21 Sep 2007 (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 laparoscopic repair of ventral hernias is still a controversial therapeutic option. To evaluate the efficacy and safety of laparoscopic repair we compare the results of the open and laparoscopic repair of ventral hernia,. 53 patients were undergo laparoscopic or open repair of ventral hernia . All defects were estimated to be larger than 5 cm in diameter. Twenty six patients underwent attempted laparoscopic ventral hernia repair (LVHR) with mesh and twenty seven patients underwent open ventral hernia repair (OVHR) with mesh
Detailed description
Between March 2003 and December 2004, 53 patients (16 males and 37 females) with ventral hernias were treated by a laparoscopic or open approach. Patients were divided into two groups: one group underwent laparoscopic repair with GORE-TEX Dual Mesh, and the other group underwent open repair with proline mesh. Informed written consents were obtained from all patients.
Inclusion criteria involved any patient aged over 30 years, medical fitness for general anesthesia, the absence of coagulopathy, and hernial defect ≥ 5 cm in any dimension or recurrent hernias. Exclusion criteria were neoplastic patients, immune compromised patients, mentally incompetent patients and those who refused to give signed consents.
Demographic features, operative details and postoperative outcomes were collected prospectively and included patient age, gender, body mass index (BMI) (weight in kg/height in m2), number of prior abdominal operations, number of previous hernia repairs, technique of repair, size of facial defect, type of prosthetic mesh, operating time, conversion rate, length of hospital stay, operative and postoperative complications, and hernia recurrences.
Thirty-seven patients presented with an incisional hernia (12 upper midline, 15 lower midline, and 10 transverse abdominal), 8 had an epigastric hernia, 8 had an periumbilical hernia, . All defects were estimated to be larger than 5 cm in diameter.
Standard bowel preparation was undertaken for every patient on the day before the operation. Prophylactic short-term antibiotic therapy with a one gram of third-generation cephalosporin was also administered routinely two hours before the operation. Nasogastric suction and bladder catheterization were used routinely during the operation only. All operations were performed under general anesthesia; Open mesh repair was done as described else where (9, 10).
Operative Procedure of laparoscopic ventral hernia repair:
pneumoperitoneum was established by using a Verses needle. The initial entry site was usually just inferior to the tip of the eleventh rib to establish a 15 mmHg pneumoperitoneum for exploration of the abdomen. One 10-mm trocar and three to five 5-mm trocars were then placed outside the perimeter of the hernia. Adhesiolysis was performed to free the anterior abdominal wall and identify the hernia defect. The peritoneal sac was not reduced and the mesh was placed in an intraabdominal position.
The mesh was prepared to extend 3 to 5 cm beyond the hernia defect. Four anchoring sutures were placed in the corners of the mesh, which was then introduced into the abdomen via a 10-mm port. The sutures were secured across the full thickness of the abdominal wall with the use of a laparoscopic suture passer. A laparoscopic mesh stapler device was used to place 5-mm spiral staples at 1-cm intervals around the mesh edge. . No drains were placed.
Postoperative management intravenous analgesia was administered postoperatively. All patients were encouraged to move as soon as possible. Postoperatively, the severity of pain was assessed daily by a visual analogue scale (VAS) on a scale from 0 (no pain) to 10 (worst pain). Upon discharge, all patients were taught to complete a pain score chart at home for daily documentation of pain score at rest and on coughing.
Follow up at the surgical Clinic was scheduled at 1 week, 8 weeks and 1 and 2 years after operation for assessment of postoperative complications: seromas (collection of fluid persisting > 4 weeks or causing local discomfort), hematomas, infection, abdominal wall pain, bowel obstruction, recurrences, aesthetic evaluation. The pain score charts were collected by the surgeon at the surgical clinic. All complications were recorded and clinical recurrence was documented during follow up.
Also, the outcome evaluation was measured by the duration of return to activity, pain free return to activity, return to work and pain free return to work.
Statistical analysis Variables measured on a nominal scale were analyzed in the form of 2 x K tables and Fisher's exact test when appropriate. Variables measured on an ordinal scale were analyzed by kruskal Wallis test. All tests were two tailed and made at a level of significance of < 0.05.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: laparoscopiclaparoscopy |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged over 30 years
- Medical fitness for general anesthesia
- The absence of coagulopathy, and hernial defect ≥ 5 cm in any dimension or recurrent hernias.
Key exclusion criteria (4 listed)
- Neoplastic patients
- Immune compromised patients
- Mentally incompetent patients; and
- Those who refused to give signed consents.
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 |
|---|---|---|
| laparoscopic | Other | 1 |
Primary outcome
Not reported in the source record.
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 21 Sep 2007.
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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.
tarek mahdy, md principal investigator
Mansoura University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic in people with Hernia, Ventral, run by Mansoura University at 2 sites in Egypt.
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 3 inclusion and 4 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 21 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
Where can I read the original study information?
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 21 Sep 2007.