Gastropexy in the Repair of Patients with Paraesophageal Hernias
- Conditions
- Paraesophageal Hernia
- Interventions
- Procedure: Gastropexy
- Registration Number
- NCT06107634
- Lead Sponsor
- Ersta Diakoni
- Brief Summary
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.
- Detailed Description
Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.
Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.
Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.
Follow-Up Assessments:
Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.
Patient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:
SF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard paraesophageal hernia repair +gastropexy Gastropexy Standard paraesophageal hernia repair with the addition of gastropexy(anterior, posterior and left gastropexy)
- Primary Outcome Measures
Name Time Method Recurrence of hernia at 1 year after surgery 1 year Computer tomography of abdomen and thorax
- Secondary Outcome Measures
Name Time Method Complications after surgery 30 days after surgery Complication classified according to Clavien-Dindo
Length of stay at the hospital after surgery 30 days after surgery Information from patients journal
Changes in the patients perception of quality of life after surgery 3 months, 12 months, and 36 months 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.
Recurrence of hernia at 3 years after surgery 3 year Computer tomography of abdomen and thorax
Changes in the patients perception of gastrointestinal symptoms after surgery 3 months, 12 months, and 36 months GSRS (The Gastrointestinal Symptom Rating Scale) is a questionnaire, which contains 15 items, and uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. The questions are grouped in five dimensions. A mean value for the items in each dimension will be calculated:
Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation
Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus
Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation
Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting
Reflux syndrome: 2. Heartburn 3. Acid regurgitation.Changes in the patients perception of dysphagia after surgery 3 months, 12 months, and 36 months The Dakkak dysphagia score is a questionnaire for assessing benign dysphagia, including nine questions regarding the frequency (always, sometimes, or never) of swallowing difficulties with different food consistencies (liquid, semisolid, and solid foods). The final score ranges from 0 to 45, where 45 represents the most severe dysphagia.
Changes in the patients perception of dysphagia and reflux frequency after surgery 3 months, 12 months, and 36 months Symptoms of heartburn, reflux, chest pain, dysphagia for liquids and solids, dyspnea, coughing and odynophagia were recorded using a four-graded scale to assess the frequency of symptoms with an arbitrary (empirical) cut off for clinical significance. The same instrument has been used in a previous RCT, from the same institution, comparing different types of anti-reflux procedures.
Trial Locations
- Locations (6)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Skåne University Hospital Lund
🇸🇪Lund, Sweden
Nyköping Hospital
🇸🇪Nyköping, Sweden
Sundsvall County Hospital
🇸🇪Sundsvall, Sweden
Uppsala Academic Hospital
🇸🇪Uppsala, Sweden
Ersta Hospital
🇸🇪Stockholm, Sweden