Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia

Achalasia Cardia Clinical Trial

Official title:

Randomised Clinical Trial Comparing Relief of Dysphagia Between Laparoscopic Heller's Myotomy Alone Versus Laparoscopic Heller's Myotomy With Anterior Fundoplication In Achalasia Cardia-A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03438838
• Other study ID #: GIPMER
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia Cardia
• Esophageal Achalasia

Intervention

Procedure:
• Laparoscopic 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
• Anterior 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

Locations

Country	Name	City	State
India	GIPMER	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Dysphagia	None- 0 Occasional-1 Daily-2 Each meal-3	Minimum one month after surgery
Secondary	Manometry pressure	Using High resolution Manometry	Minimum one month after surgery
Secondary	Gastro esophageal reflux	GERD symptoms	Minimum after one month
Secondary	Eckardt's score	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	Minimum after one month