Achalasia Cardia
Conditions
Keywords
Achalasia, LHM, Anterior fundoplication
Brief summary
Back ground: Achalasia Cardia (AC) manifests with major symptom dysphagia. Surgery as the treatment modality relieves dysphagia in most of the patients. Laparoscopic Heller's myotomy(LHM) is the surgery of choice but is associated with gastroesophageal reflux. Anterior fundoplication (Dor Fundoplication) is usually combined with LHM in patients with AC. It reduces gastroesophageal reflux following LHM. It has been observed that along with reduction of gastroesophageal reflux Dor Fundoplication also affects relief of dysphagia. But it has not been prospectively studied. Hypothesis:The hypothesis of present study is that Frequency of dysphagia following Laparoscopic Heller's myotomy with Dor fundoplication is more than that compared to Laparoscopic Heller's myotomy alone in patients with Achalasia Cardia. Methods: From December2017 to November 2018 minimum of 20 patients with diagnosis of Achalasia cardia will be randomized to receive either Laparoscopic Heller's myotomy (LHM) alone or LHM with Dor fundoplication. Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardt's score. . Outcomes: Primary outcome is Frequency of dysphagia and secondary outcome is manometry pressure assessment. Statistical analysis would be done using Statistical Package for the Social Sciences (SPSS) soft ware. P value \< 0.05 is considered significant.
Interventions
PROCEDURELaparoscopic Heller's myotomy
Laparoscopic Heller's myotomy: Anterior wall of esophagus is exposed by opening peritoneum and minimal dissection of fat over it. Myotomy is started at 2 cm above the esophago- gastric junction. Initial plane is created using dissector and further muscles are split using pair of dissector or bowel holding forceps for length of 7 to 8 cm with 2 cm over stomach
PROCEDUREAnterior Fundoplication
The Fundus was sutured with 3 stitches on either side of the esophagus to right and left crus of diaphragm using ethibond(1-0) beside intervening stitch over esophagus. Width of fundoplication is kept approximately at 2cm. The proximal short gastric vessels were divided only if the fundus is insufficiently mobile
Sponsors
Govind Ballabh Pant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be randomized using computer generated table of random numbers contained in a sealed opaque envelope to be opened in operation theatre after induction anesthesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients (18 years or more) with Achalasia cardia
Exclusion criteria
* Patients of achalasia with axis deviation * Patients with history of pneumatic dilatation * Patient with other associated motility or non motility disorders * Patients with pseudoachalasia Prior gastric or esophageal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Dysphagia | Minimum one month after surgery | None- 0 Occasional-1 Daily-2 Each meal-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manometry pressure | Minimum one month after surgery | Using High resolution Manometry |
| Gastro esophageal reflux | Minimum after one month | GERD symptoms |
| Eckardt's score | Minimum after one month | Dysphagia * 0-None * 1-Occasional * 2-Daily * 3-Each meal Retrosternal pain * 0-None * 1-Occasional * 2-Daily * 3-Each meal Regurgitation * 0-None * 1-Occasional * 2-Daily * 3-Each meal Weight loss * 0-None * 1-less than 5 kg * 2-5 to 10kg * 3-more than 10kg Minimum score: 0 Maximum score: 12 |
Countries
India
Outcome results
None listed