Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2018
CompletedFirst Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 23, 2022
March 1, 2022
4.6 years
February 13, 2018
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Dysphagia
None- 0 Occasional-1 Daily-2 Each meal-3
Minimum one month after surgery
Secondary Outcomes (3)
Manometry pressure
Minimum one month after surgery
Gastro esophageal reflux
Minimum after one month
Eckardt's score
Minimum after one month
Study Arms (2)
Laparoscopic Heller's Myotomy (LHM)alone
ACTIVE COMPARATORA minimum 10 patients undergo Laparoscopic Heller's myotomy alone
LHM with Anterior Fundoplication
ACTIVE COMPARATORA Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication
Interventions
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
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
Eligibility Criteria
You may qualify if:
- All adult patients (18 years or more) with Achalasia cardia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GIPMER
New Delhi, 110002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hirdaya H Nag, MS
GIPMER
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Prof
Study Record Dates
First Submitted
February 13, 2018
First Posted
February 20, 2018
Study Start
January 24, 2018
Primary Completion
August 31, 2022
Study Completion
December 31, 2022
Last Updated
March 23, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share