Ventral HerniasCLOSE-GAPNCT01962480
The Effect of Laparoscopically Closing the Hernia Defect in Laparoscopic Ventral Hernia Repair on Postoperative Pain
A study testing The hernia gap is sutured intracorporally in people with Ventral Hernias, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventral Hernias
- What is being tested?
- The hernia gap is sutured intracorporally
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Feb 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective, primary or recurrent laparoscopic umbilical or epigastric hernia repair, umbilical trocar-site hernia and epigastric hernia repair where laparoscopic hernia repair is no contraindication (i.e. previous laparotomy with anticipated severe and dense adhesions
- Hernia defect between 2-6 cm measured preoperatively by the surgeon at the out-patient clinic
- Maximum 1 defect
- Patients 18-80 years Patients with technical failure (where it is not possible to suture the defect) or patients who are reoperated due to complications remain included and will stay in their primary assigned randomization group in order to perform an intention to treat (ITT) analysis.
Who cannot join
- Open hernia repair
- Poor compliance (language problems, dementia and alcohol or drug abuse etc.)
- Fascia defect >6 cm (largest diameter, evaluated preoperatively and intra-operatively, thus patients are excluded if the defect is found larger intra-operatively)
- Emergency repair
- Chronic pain syndrome (chronic back pain, chronic headache, severe dysmenorrhea, fibromyalgia, whiplash or other conditions requiring daily opioid medication)
- Daily consumption of opioids (for the last 3 weeks up till the operation)
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- Decompensated liver cirrhosis (Child-Pugh B-C)
- If the hernia repair is secondarily to another surgical procedure
- If a patient withdraws his/her inclusion consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effects of Intracorporally Closure of the Hernia Defect in Laparoscopic Umbilical or Epigastric Hernia Repair
Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have sporadically been reported but no evidence is available from randomized controlled trials.
The primary purpose is to compare early postoperative activity-related pain in patients undergoing ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence and chronic pain after 2 years.
Read more
Material and Methods: A randomized, controlled, double-blinded study is planned. Based on power calculation we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to participate.
Conclusion: The technique with closure of the gap may induce more postoperative pain, but may be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.
- Conditions
- Ventral Hernias
- Being tested
- The hernia gap is sutured intracorporally
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The hernia gap is sutured intracorporallyProcedure or surgery
The hernia gab is closed with non-absorbable suture (Ethibond Excel 2-0, Ethicon, Johnson \& Johnson©) performed by an intracorporally interrupted sutured technique using an Auto Suture© Endo-Slide knot-tying instrument. The stitches are placed with a distance of 0.5 - 1 cm from the fascial edges and with a distance of 0.5-1 cm. between the stitches, performed under a 6-8 mmHg intrabdominal pressure.
| Study group | Role | What they receive |
|---|---|---|
| sutured closure of the hernia gap | Active comparator | The hernia gap is sutured intracorporally Receives: Procedure: The hernia gap is sutured intracorporally |
| No closure of the hernia gap | No intervention | Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
Measured: 24 hrs postoperatively
Secondary outcomes (1)
Cosmetic result measured with verbal rating scale and numeric rating scales
Measured: measured 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Mette Willaume Christoffersen, Hvidovre University Hospital
- Investigators
- Mette Christoffersen, M.D., Principal investigator, Individual Purchaser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962480
- Sponsor's protocol ID
- CLOSE-GAP-1
- Acronym
- CLOSE-GAP
- Status last verified
- Feb 2019
- First submitted
- 7 Oct 2013
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M. Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD007781. doi: 10.1002/14651858.CD007781.pub2.
PubMed 21412910Christoffersen MW, Westen M, Rosenberg J, Helgstrand F, Bisgaard T. Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial. Br J Surg. 2020 Feb;107(3):200-208. doi: 10.1002/bjs.11490.
PubMed 31971616Christoffersen MW, Westen M, Assadzadeh S, Deigaard SL, Rosenberg J, Bisgaard T. The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial. Dan Med J. 2014 Jun;61(6):A4865.
PubMed 24947633
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Intracorporally Closure of the Hernia Defect in Laparoscopic Umbilical or Epigastric Hernia Repair
- ClinicalTrials.gov ID
- NCT01962480
- Acronym / sponsor ID
- CLOSE-GAP / CLOSE-GAP-1
- Conditions
- Ventral Hernias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 14 Oct 2013 (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.
Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have sporadically been reported but no evidence is available from randomized controlled trials.
The primary purpose is to compare early postoperative activity-related pain in patients undergoing ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence and chronic pain after 2 years.
Material and Methods: A randomized, controlled, double-blinded study is planned. Based on power calculation we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to participate.
Conclusion: The technique with closure of the gap may induce more postoperative pain, but may be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sutured closure of the hernia gap | Active comparator | Procedure: The hernia gap is sutured intracorporallyThe hernia gap is sutured intracorporally |
| No closure of the hernia gap | No intervention | –Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective, primary or recurrent laparoscopic umbilical or epigastric hernia repair, umbilical trocar-site hernia and epigastric hernia repair where laparoscopic hernia repair is no contraindication (i.e. previous laparotomy with anticipated severe and dense adhesions
- Hernia defect between 2-6 cm measured preoperatively by the surgeon at the out-patient clinic
- Maximum 1 defect
- Patients 18-80 years Patients with technical failure (where it is not possible to suture the defect) or patients who are reoperated due to complications remain included and will stay in their primary assigned randomization group in order to perform an intention to treat (ITT) analysis.
Key exclusion criteria (9 listed)
- Open hernia repair
- Poor compliance (language problems, dementia and alcohol or drug abuse etc.)
- Fascia defect >6 cm (largest diameter, evaluated preoperatively and intra-operatively, thus patients are excluded if the defect is found larger intra-operatively)
- Emergency repair
- Chronic pain syndrome (chronic back pain, chronic headache, severe dysmenorrhea, fibromyalgia, whiplash or other conditions requiring daily opioid medication)
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 |
|---|---|---|
| The hernia gap is sutured intracorporallyThe hernia gab is closed with non-absorbable suture (Ethibond Excel 2-0, Ethicon, Johnson \& Johnson©) performed by an intracorporally interrupted sutured technique using an Auto Suture© Endo-Slide knot-tying instrument. The stitches are placed with a distance of 0.5 - 1 cm from the fascial edges and with a distance of 0.5-1 cm. between the stitches, performed under a 6-8 mmHg intrabdominal pressure. | Procedure or surgery | sutured closure of the hernia gap |
Primary outcome
Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
Time frame: 24 hrs postoperatively
1 secondary outcome
Cosmetic result measured with verbal rating scale and numeric rating scales
Time frame: measured 30 days postoperatively
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 22 Feb 2019.
- Background: PubMed 21412910Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M. Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD007781. doi: 10.1002/14651858.CD007781.pub2.
- Derived from this study: PubMed 31971616Christoffersen MW, Westen M, Rosenberg J, Helgstrand F, Bisgaard T. Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial. Br J Surg. 2020 Feb;107(3):200-208. doi: 10.1002/bjs.11490.
- Derived from this study: PubMed 24947633Christoffersen MW, Westen M, Assadzadeh S, Deigaard SL, Rosenberg J, Bisgaard T. The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial. Dan Med J. 2014 Jun;61(6):A4865.
- Individual participant dataSharing planned: No
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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.
Mette Christoffersen, M.D. principal investigator
Individual Purchaser
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The hernia gap is sutured intracorporally in people with Ventral Hernias, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 9 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 22 Feb 2019. 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 Denmark. 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?
Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale (time frame: 24 hrs postoperatively). 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 NCT01962480, which also lists 3 linked publications.
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 22 Feb 2019.