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NCT03438838
Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia
NA trial testing Laparoscopic Heller's myotomy in Achalasia Cardia in 20 participants. Status unknown.
31 August 2022
Quick facts
| Lead sponsor | Govind Ballabh Pant Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 24 January 2018 |
| Primary completion | 31 August 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- Laparoscopic Heller's myotomy
- Anterior Fundoplication
Conditions studied
- Achalasia Cardia — all drugs for Achalasia Cardia →
Sponsor
Govind Ballabh Pant Hospital
Who can join
18 and older, any sex, with Achalasia Cardia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT03438838
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Related trials
Other recruiting trials for Achalasia Cardia
Currently open trials in the same condition.
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- NCT07022886 — INCIDENCE, PREVALENCE AND OVERALL RISK OF ESOPHAGEAL CANCER IN ACHALASIA: A PROPENSITY-MATCHED POPULATION-BASED STUDY FR · active not recruiting
- NCT06290882 — Endoscopic Versus Robotic Myotomy for Treatment of Achalasia · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03438838 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Govind Ballabh Pant Hospital
- Last refreshed: 23 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03438838.
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