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

NCT03438838 — Not applicable, Unknown, 20 participants, Govind Ballabh Pant Hospital

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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

Registry	NCT03438838
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	20 (Actual)
Sponsor	Govind Ballabh Pant Hospital (Other gov)
Conditions	Achalasia Cardia
Interventions	Laparoscopic Heller's myotomy, Anterior Fundoplication (Procedure)
Dates	start 2018-01-24, primary completion 2022-08-31 (estimated), completion 2022-12-31 (estimated), first posted 2018-02-20, last updated 2022-03-23
Locations	1 site in India

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Laparoscopic Heller's Myotomy (LHM)alone	Active comparator	Procedure: Laparoscopic Heller's myotomy	A minimum 10 patients undergo Laparoscopic Heller's myotomy alone
LHM with Anterior Fundoplication	Active comparator	Procedure: Laparoscopic Heller's myotomy; Procedure: Anterior Fundoplication	A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication

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
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

+Outcome measures

Primary outcomes

Frequency of Dysphagia [Minimum one month after surgery]: None- 0 Occasional-1 Daily-2 Each meal-3

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
GIPMER	New Delhi	India

+Investigators

Hirdaya H Nag, MS, Principal investigator, GIPMER

My Notes

Public

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