Paraesophageal Hernia
Conditions
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.
Interventions
PROCEDUREGastropexy
In 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).
PROCEDUREParaesophageal hernia repair
Ultrasonic 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.
Sponsors
Göteborg University
Sundsvall Hospital
Karolinska Institutet
Ersta Diakoni
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
Intervention model description
Conventional paraesophageal hernia repair with the addition of gastropexy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of hernia at 1 year after surgery | 1 year | Computer tomography of abdomen and thorax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
Sweden
Contacts
Primary ContactMarcus Reuterwall Hansson, PhD
Outcome results
None listed