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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Heller's Myotomy (LHM)alone | Active Comparator | A minimum 10 patients undergo Laparoscopic Heller's myotomy alone |
|
| LHM with Anterior Fundoplication | Active Comparator | A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Heller's myotomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Dysphagia | None- 0 Occasional-1 Daily-2 Each meal-3 | Minimum one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Manometry pressure | Using High resolution Manometry | Minimum one month after surgery |
| Gastro esophageal reflux | GERD symptoms | Minimum after one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hirdaya H Nag, MS | GIPMER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GIPMER | New Delhi | 110002 | India |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000074434 | Heller Myotomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
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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.
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| Anterior Fundoplication | Procedure | 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 |
|
| Eckardt's score | Dysphagia
Minimum score: 0 Maximum score: 12 | Minimum after one month |
| D004066 | Digestive System Diseases |