Gastropexy in the Repair of Patients with Paraesophageal Hernias
ConditionParaesophageal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErsta Diakoni
About this trial
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
Diagnosis of achalasia or any other significant esophageal motility disorder.
Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.
Trial design
Design model
Parallel
Treatments tested in this trial
Gastropexy
Procedure/SurgeryIn the intervention group, a three-point gastropexy is added to the repair. First, the right fundus flap is adapted posteriorly to the crural portion of the diaphragm with a 2-3 cm long running non-absorbable suture ("posterior gastropexy"). Second, the left fundus flap is adapted to the diaphragm anterolateral to the hiatus with a 2-3 cm long running non-absorbable suture ("left anterolateral gastropexy"). Finally, the minor curvature of the anterior stomach wall is adapted during reduced intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy").
Paraesophageal hernia repair
Procedure/SurgeryUltrasonic shears are used for dissection. The herniated viscera are completely reduced into the abdomen and the hernia sac in fully dissected and resected. The esophagus is mobilized intraabdominally until at least 3 cm rests below the hiatus without tension. The anterior and posterior vagal nerves are identified and preserved. A posterior crural closure with running non-absorbable sutures is performed. An additional anterior crural closure may be performed at the surgeon's discretion. The fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Standard paraesophageal hernia repairActive comparator 1 intervention
Group B: Standard paraesophageal hernia repair + gastropexyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Recurrence of hernia at 1 year after surgery
Computer tomography of abdomen and thorax
Time frame
1 yearSecondary outcomes
1
Recurrence of hernia at 3 years after surgery
Computer tomography of abdomen and thorax
Time frame
3 year2
Complications after surgery
Complication classified according to Clavien-Dindo
Time frame
30 days after surgery3
Length of stay at the hospital after surgery
Information from patients journal
Time frame
30 days after surgery4
Changes in the patients perception of quality of life after surgery
SF-36 (Short Form 36) is a health related quality of life questionnaire. SF-36 is comprised of 36 items that assess eight dimensions of health: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Higher scores mean a better outcome. These can be grouped into mental and physical component summary scores. Scoring is from 0-100. A mean score of 50 has been articulated as normative value.
Time frame
3 months, 12 months, and 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ersta Diakoni
Lead sponsor
Göteborg University
Collaborator
Sundsvall Hospital
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov