Hernia, VentralNCT05446675
Endoscopic eTEP Versus Open Rives-Stoppa
An observational study of Hernia, Ventral and Rectus Diastasis, run by AZ Alma at 1 site in Belgium.
Trial summary
Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hernia, Ventral, Rectus Diastasis
- What is being tested?
- Endoscopic eTEP and Open Rives-Stoppa
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jun 2022to 23 Dec 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
Study population: Participants who underwent repair for their midline abdominal wall hernias alongside rectus abdominis diastasis.
Who may be able to join
- Group 1 (eTEP):
- Participants who underwent an eTEP procedure in the investigators' center
- Preoperative existence of one or more midline abdominal wall hernias
- Preoperative existence of rectus abdominis diastasis
- Group 2 (Rives-Stoppa, control group):
- Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center
Who cannot join
- Group 1 (eTEP):
- Preoperative absence of midline abdominal wall hernias
- Preoperative absence of rectus abdominis diastasis
- Intraoperative performance of transverse abdominis release (TAR)
- Intraoperative inguinal hernia repair
- Group 2 (Rives-Stoppa, control group):
Show all 9Show fewer
- Intraoperative performance of transverse abdominis release (TAR)
- Intraoperative performance of anterior component separation
- Intraoperative inguinal hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center Observational Study With Comparison of Endoscopic Extended-View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias With Rectus Diastasis
Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).
Read the detailed description
See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.
- Conditions
- Hernia, Ventral, Rectus Diastasis
- Being tested
- Endoscopic eTEP, Open Rives-Stoppa
- Keywords
- eTEP, Retromuscular, Minimally invasive, Endoscopic, Hernia, Rectus diastasis, Rives-Stoppa
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic eTEPProcedure or surgery
Endoscopic extended view totally extraperitoneal prosthesis repair.
Open Rives-StoppaProcedure or surgery
Open Rives-Stoppa repair with retromuscular mesh placement.
| Study group | Role | What they receive |
|---|---|---|
| eTEP | First 30 participants who meet the inclusion criteria and do not exhibit any of the exclusion criteria will be investigated. The option for endoscopic eTEP repair, if feasible, is given preoperatively as a standard for the treatment of symptomatic midline abdominal wall hernias with concomitant rectus abdominis diastasis as an alternative to open Rives-Stoppa mesh repair. The modality of operative treatment is made in cooperation with the participant. Receives: Procedure: Endoscopic eTEP | |
| Rives-Stoppa, control | Thirty participants will be selected out of all patients who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center and who do not meet any of the exclusion criteria. Participant selection will consist of matching to participants in group 1 according to gender and age (e.g. a male participant in group 1 will be matched to a male participant (group 2) out of the investigators' records who underwent an open Rives-Stoppa repair and whose age most closely resembles the age of the matched participant in group 1). Receives: Procedure: Open Rives-Stoppa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Time (days) spent within the hospital
Measured: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.
Postoperative pain management
Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration
Measured: From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.
Secondary outcomes (2)
Intraoperative complications
Adverse event occurrence
Measured: During surgery
Postoperative complications
Adverse event occurrence by readmission
Measured: After discharge until 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start9 Jun 2022
- Primary completion30 Aug 2022
- Study completion23 Dec 2022
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 Hernia, VentralStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- AZ Alma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Kinet, MD, Principal investigator, AZ Alma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446675
- Sponsor's protocol ID
- EC/EH/220608-SK
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be sent to journal at time of application for publication after completion. IPD will be shared via the online EHS registry with contents adhering to their format. Accessible to all EHS members for all types of analyses.
Publications
Kinet S, Maes H, Van Cleven S, Brusselaers N, Kuppens EFP. Endoscopic enhanced-view totally extraperitoneal prosthetic (eTEP) versus open Rives-Stoppa repair as a treatment of midline abdominal wall hernias with rectus diastasis: comparison of postoperative pain and length of hospital stay in a single-centre surgical cohort. Updates Surg. 2024 Dec;76(8):2923-2931. doi: 10.1007/s13304-024-01905-4. Epub 2024 Jun 23.
PubMed 38909352
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Observational Study With Comparison of Endoscopic Extended-View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias With Rectus Diastasis
- ClinicalTrials.gov ID
- NCT05446675
- Acronym / sponsor ID
- EC/EH/220608-SK
- Conditions
- Hernia, Ventral, Rectus Diastasis
- Keywords
- eTEP, Retromuscular, Minimally invasive, Endoscopic, Hernia, Rectus diastasis, Rives-Stoppa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AZ AlmaUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 7 Jul 2022 (actual)
- 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.
Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).
Detailed description
See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTEP | – | Procedure: Endoscopic eTEPFirst 30 participants who meet the inclusion criteria and do not exhibit any of the exclusion criteria will be investigated. The option for endoscopic eTEP repair, if feasible, is given preoperatively as a standard for the treatment of symptomatic midline abdominal wall hernias with concomitant rectus abdominis diastasis as an alternative to open Rives-Stoppa mesh repair. The modality of operative treatment is made in cooperation with the participant. |
| Rives-Stoppa, control | – | Procedure: Open Rives-StoppaThirty participants will be selected out of all patients who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center and who do not meet any of the exclusion criteria. Participant selection will consist of matching to participants in group 1 according to gender and age (e.g. a male participant in group 1 will be matched to a male participant (group 2) out of the investigators' records who underwent an open Rives-Stoppa repair and whose age most closely resembles the age of the matched participant in group 1). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who underwent repair for their midline abdominal wall hernias alongside rectus abdominis diastasis.
Key inclusion criteria (6 listed)
- Participants who underwent an eTEP procedure in the investigators' center
- Preoperative existence of one or more midline abdominal wall hernias
- Preoperative existence of rectus abdominis diastasis
- Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center
Key exclusion criteria (9 listed)
- Preoperative absence of midline abdominal wall hernias
- Preoperative absence of rectus abdominis diastasis
- Intraoperative performance of transverse abdominis release (TAR)
- Intraoperative inguinal hernia repair
- Intraoperative performance of transverse abdominis release (TAR)
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 |
|---|---|---|
| Endoscopic eTEPEndoscopic extended view totally extraperitoneal prosthesis repair. | Procedure or surgery | eTEP |
| Open Rives-StoppaOpen Rives-Stoppa repair with retromuscular mesh placement. | Procedure or surgery | Rives-Stoppa, control |
Primary outcome
Length of hospital stay
Time frame: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.
Time (days) spent within the hospital
Postoperative pain management
Time frame: From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.
Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration
2 secondary outcomes
Intraoperative complications
Time frame: During surgery
Postoperative complications
Time frame: After discharge until 30 days postoperative
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 23 Feb 2024.
- Derived from this study: PubMed 38909352Kinet S, Maes H, Van Cleven S, Brusselaers N, Kuppens EFP. Endoscopic enhanced-view totally extraperitoneal prosthetic (eTEP) versus open Rives-Stoppa repair as a treatment of midline abdominal wall hernias with rectus diastasis: comparison of postoperative pain and length of hospital stay in a single-centre surgical cohort. Updates Surg. 2024 Dec;76(8):2923-2931. doi: 10.1007/s13304-024-01905-4. Epub 2024 Jun 23.
- Individual participant dataSharing planned: Yes. Study protocol will be sent to journal at time of application for publication after completion. IPD will be shared via the online EHS registry with contents adhering to their format. Accessible to all EHS members for all types of analyses.
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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.
Sam Kinet, MD principal investigator
AZ Alma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Ventral and Rectus Diastasis, run by AZ Alma at 1 site in Belgium.
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 6 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 23 Feb 2024. 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 Belgium. 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?
Length of hospital stay (time frame: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.). The study lists 2 primary outcomes in all. 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 NCT05446675, 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 23 Feb 2024.