Achalasia CardiaNCT03438838
Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia
A study testing Laparoscopic Heller's myotomy and Anterior Fundoplication in people with Achalasia Cardia, run by Govind Ballabh Pant Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia Cardia
- What is being tested?
- Laparoscopic Heller's myotomy and Anterior Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 24 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (18 years or more) with Achalasia cardia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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".
Read more
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.
- Conditions
- Achalasia Cardia
- Being tested
- Laparoscopic Heller's myotomy, Anterior Fundoplication
- Keywords
- Achalasia, LHM, Anterior fundoplication
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Heller's myotomyProcedure or surgery
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 FundoplicationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Heller's Myotomy (LHM)alone | Active comparator | A minimum 10 patients undergo Laparoscopic Heller's myotomy alone Receives: Procedure: Laparoscopic Heller's myotomy |
| LHM with Anterior Fundoplication | Active comparator | A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication Receives: Procedure: Laparoscopic Heller's myotomy; Procedure: Anterior Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Dysphagia
None- 0 Occasional-1 Daily-2 Each meal-3
Measured: Minimum one month after surgery
Secondary outcomes (3)
Manometry pressure
Using High resolution Manometry
Measured: Minimum one month after surgery
Gastro esophageal reflux
GERD symptoms
Measured: Minimum after one month
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
Measured: Minimum after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start24 Jan 2018
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hirdaya H Nag, MS, Govind Ballabh Pant Hospital
- Investigators
- Hirdaya H Nag, MS, Principal investigator, GIPMER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438838
- Sponsor's protocol ID
- GIPMER
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2018
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03438838
- Acronym / sponsor ID
- GIPMER
- Conditions
- Achalasia Cardia
- Keywords
- Achalasia, LHM, Anterior fundoplication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Heller's Myotomy (LHM)alone | Active comparator | Procedure: Laparoscopic Heller's myotomyA minimum 10 patients undergo Laparoscopic Heller's myotomy alone |
| LHM with Anterior Fundoplication | Active comparator | Procedure: Laparoscopic Heller's myotomy, Procedure: Anterior FundoplicationA Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (18 years or more) with Achalasia cardia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Heller's myotomyLaparoscopic 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 | Procedure or surgery | LHM with Anterior Fundoplication, Laparoscopic Heller's Myotomy (LHM)alone |
| Anterior FundoplicationThe 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 | Procedure or surgery | LHM with Anterior Fundoplication |
Primary outcome
Frequency of Dysphagia
Time frame: Minimum one month after surgery
None- 0 Occasional-1 Daily-2 Each meal-3
3 secondary outcomes
Manometry pressure
Time frame: Minimum one month after surgery
Gastro esophageal reflux
Time frame: Minimum after one month
Eckardt's score
Time frame: Minimum after one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hirdaya H Nag, MS principal investigator
GIPMER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Heller's myotomy and Anterior Fundoplication in people with Achalasia Cardia, run by Govind Ballabh Pant Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Dysphagia (time frame: Minimum one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.