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

March 22, 2022 updated by: Hirdaya H Nag, MS, Govind Ballabh Pant Hospital

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".

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110002
        • GIPMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Laparoscopic Heller's Myotomy (LHM)alone
A minimum 10 patients undergo Laparoscopic Heller's myotomy alone
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
ACTIVE_COMPARATOR: LHM with Anterior Fundoplication
A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication
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

Procedure: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of Dysphagia
Time Frame: Minimum one month after surgery
None- 0 Occasional-1 Daily-2 Each meal-3
Minimum one month after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Manometry pressure
Time Frame: Minimum one month after surgery
Using High resolution Manometry
Minimum one month after surgery
Gastro esophageal reflux
Time Frame: Minimum after one month
GERD symptoms
Minimum after one month
Eckardt's score
Time Frame: 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
Minimum after one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Govind Ballabh Pant Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hirdaya H Nag, MS, GIPMER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GIPMER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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