Paraesophageal Hernia
Conditions
Brief summary
Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.
Detailed description
Patient undergoing surgery for primary paraesophageal herniation, are randomized to either conventional suturing of the diaphragmatic crura only or with the addition of a diaphragmatic incision lateral release. The patients are examined by computed tomography before surgery and at 1 and 3 years after surgery. SF-36 (global quality of Life instrument), GSRS (Gastrointestinal Symptoms Rating Scale), Reflux frequency issues and Watson's dysphagia score are completed before and at 3 and 6 month as well as 1 and 3 years after surgery. Patients undergoing laparoscopic repair for paraesophageal hernia Type II-IV are eligible for inclusion in the study. Included patients will be randomized to either reconstruction of the hiatus by suturing of the crura alone or in combination with an approximately 4 cm incision of the anterior aspect of the left diaphragma lateral release before crural suturing. The incision will be covered with a synthetic patch after crural closure is finished. All other aspects of the surgical procedure are similar in the two groups including complete mobilization of the hernia sac before and a total fundoplication after hiatal restoration, respectively.
Interventions
PROCEDURECrura plastic
Closure of hiatus with a running suture
Sponsors
Karolinska Institutet
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
Crura plastic or crura plastic with the addition of lateral release
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery
Exclusion criteria
* inability to understand the nature of the purpose of the study and/or to give informed consent. * American Society of Anesthesiologists physical status-system (ASA) \>III * Achalasia or another severe esophageal motor disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rat of reherniating | 1 year | computer tomography of abdomen and thorax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sick leave period | 1 year | Days, information from the patient |
| complications after operation | 1 year | symptomatic recurrence |
| change in quality of life | 1 year | SF-36 (Quality of Life issues) The SF-36 It is comprised of 36 items that assess eight health concepts: 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. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome. |
| Patients analgesic consumption after operation | 1 year | information from the patient and the patient´s journal |
| Length of Stay (LOS) | 1 year | Information from the patient's journal |
| GSRS Gastrointestinal Symptom Rating Scale | 1 year | Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should 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
Outcome results
None listed