A Phase 4 interventional study of intraperitoneal onlay mesh repair and sublay mesh repair in Umbilical Hernia, sponsored by University Hospital, Basel, Switzerland. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 306 is above the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: intraperitoneal onlay mesh repair
Procedure: sublay mesh repair
The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
early wound complications
* wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma
Time frame: 30 days after operation
late wound complications
* wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma
Time frame: 1 year after operation
complication rate perioperative
* major bleeding * bowel injury
Time frame: intraoperative complications will be recorded immediately after finishing the operation
duration of operation
measured in minutes according to operations protocol (duration cut - suture)
Time frame: the duration will be recorded immediately after finishing the operation
hospital stay
measured in days
Time frame: will be measured after discharge of the patient
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time frame: 30 days
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time frame: 1 year
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time frame: 3 years
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time frame: 5 years
navel site seroma
the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
Time frame: discharge day
navel site seroma
the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
Time frame: after 30 days
navel site seroma
the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
Time frame: after 1 year
complication rate postoperative
* trocar site hernia * enteral fistula * persistent pain * re-operation
Time frame: 30 day
complication rate postoperative
* trocar site hernia * enteral fistula * persistent pain * re-operation
Time frame: 1 year
complication rate postoperative
* trocar site hernia * enteral fistula * persistent pain * re-operation
Time frame: 3 years
complication rate postoperative
* trocar site hernia * enteral fistula * persistent pain * re-operation
Time frame: 5 years
pain score (Visual Analog Scale - VAS)
will be measured by the nurse according to Visual Analog Scale
Time frame: 24h post operative
pain score (Visual Analog Scale - VAS)
will be measured by the nurse according to Visual Analog Scale
Time frame: 48h post operative
pain score (Visual Analog Scale - VAS)
will be measured by the nurse according to Visual Analog Scale
Time frame: immediately before discharge
Quality of life (SF-36)
patients will be asked to fulfill validated SF-36 questionnaire
Time frame: 1 day pre-operative
Quality of life (SF-36)
patients will be asked to fulfill validated SF-36 questionnaire
Time frame: 30 days postoperatively
Quality of life (SF-36)
patients will be asked to fulfill validated SF-36 questionnaire
Time frame: 1 year postoperatively
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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