AzTrials
AzTrials

Symptoms and SignsNCT04152902

Quality of Life After Surgery for End-stage Achalasia

An observational study of Symptoms and Signs and Quality of Life, run by University of Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy. Read more about this study

Who is it for?
Any age
Conditions the study is for
Symptoms and Signs, Quality of Life
What is being tested?
Objective outcome and Quality of life
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteItaly
Study dates
Jan 1987to Jun 2019
How long will I take part?
70 Months
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Tertiary referral center

Who may be able to join

  • follow-up longer than 1 year
  • preoperative and postoperative endoscopy available
  • preoperative and postoperative barium swallow available
  • preoperative and postoperative manometry available

Who cannot join

  • patients undergone chemotherapy
  • patients with relapse of disease

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Division of Thoracic Surgery Maria Cecilia Hospital

    Cotignola, RA

Other trials in Italy

About this study

Official title: Quality of Life After Surgery for End-stage Achalasia: Pull-down Heller-Dor vs Esophagectomy

Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy.

The study included 31 patients (57 years) who underwent the Heller-Dor procedure with verticalisation of the distal oesophagus (pull-down technique dedicated to sigmoid oesophagus treatment) and 29 patients (recurrence free, 64 years) (p=0.539) who underwent oesophagectomy for end-stage achalasia or for cancer, extracted from a database designed for prospective clinical research. The objective outcomes of treatment were evaluated with semi-quantitative scales investigating dysphagia, reflux symptoms and endoscopic oesophagitis. Quality of life was assessed with the SF-36 questionnaire.

Read the detailed description

Patients were extracted from a database designed for prospective clinical research on benign and malignant oesophageal diseases. For this study, the investigators considered patients who underwent operations for end-stage achalasia from January 1987-July 2018 and patients who survived after primary esophagectomy for oesophageal cancer between January 2008 and December 2018 without undergoing neoadjuvant/adjuvant therapy. End-stage achalasia was diagnosed on the basis of clinical history, upper gastrointestinal tract endoscopy and barium swallow results (oesophageal diameter larger than 6 cm, distal oesophagus kinked towards the left side, outside the axis). Standard oesophageal manometry, or more recently, high-resolution manometry, was routinely performed. Cases of pseudo-achalasia (oesophageal dilation secondary to organic stenosis of the cardia) were excluded based on clinical, endoscopic and histology patterns. In the presence of end-stage achalasia Pull-down Heller-Dor was the first primary treatment option for patients with the following: a) no severe mucosal inflammation or moderate/high grade dysplasia and b) redo surgery exclusively for dysphagia relapse due to insufficient myotomy. Esophagectomy was the treatment of choice for patients with the following: a) relapsed dysphagia after myotomy due to scarring that caused stenosis of the cardia, b) iterative surgery, c) cancerization risk patterns, and d) a diagnosis of cancer.

The pull-down Helle-Dor procedure aimed to restore the vertical axis of the intraabdominal portion of the oesophagus as much as possible. In brief, before performing the myotomy and the anterior fundoplication, at least 6 cm of the mediastinal oesophagus was fully isolated; two or more U intramuscular stitches were applied on the curling of the right side of the oesophagus, pulled down and rotated towards the right side of the gastro-oesophageal junction. The pull-down Heller-Dor operation was performed under manometric control.

Esophagectomy was performed with open technique, or recently, with a minimally invasive technique. The stomach was always the oesophageal substitute, and the oesophagogastric anastomosis was preferably located at the thoracic dome or at the neck to minimize the risk of postoperative reflux oesophagitis or cancer growth in the residual dilated oesophagus. Patients who underwent esophagectomy for cancer not related to achalasia were extracted from the relative case series to form a control group that matched the end-stage achalasia study group according to age and surgical technique; these patients had not undergone neoadjuvant or adjuvant chemotherapy and were cancer free at follow-up.

The duration of achalasia symptoms was calculated starting from the date of onset to the date of surgery at the investigator's institution. After surgery, the patients underwent a timed follow-up composed of clinical interviews, upper GI tract barium swallow and endoscopy. The symptoms were evaluated according to semi-quantitative scales graded from 0 (absence) to 3 (maximal intensity) based on Van Trappen's criteria for dysphagia and Visick's criteria for gastro-oesophageal reflux. Upper GI endoscopy aimed to detect post Heller's myotomy reflux oesophagitis, Barrett's oesophagus and areas suspected for dysplasia or cancer. Reflux oesophagitis was initially assessed according to the Savary-Miller and Ismail Beigi criteria and successively assessed according to the Los Angeles classification. The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis.

Quality of life was assessed by the version of the 36-Item Short Form Survey (SF-36) validated for Italy. The questionnaire was a generic Health-Related Quality of Life (HRQL) measure that investigated eight specific health domains: physical functioning (PF), restrictions in activities due to physical (RP) or emotional health (RE), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and social functioning (SF). The SF-36 scores for each health domain ranged from 0 (poor HRQL) to 100 (best HRQL). Patients self-administered the questionnaires they received in mail for the specific purpose of this study.

Being tested
Objective outcome, Quality of life
Medical subject headings
Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Objective outcomeOther

    The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis

  • Quality of lifeOther

    SF-36 Questionnaire

Study groups in NCT04152902
Study groupRoleWhat they receive
PULL-DOWN HELLER-DORThe PD-HD procedure aimed to restore the vertical axis of the intraabdominal portion of the oesophagus as much as possible. In brief, before performing the myotomy and the anterior fundoplication according to Dor, at least 6 cm of the mediastinal oesophagus was fully isolated; two or more U intramuscular stitches were applied on the curling of the right side of the oesophagus, pulled down and rotated towards the right side of the gastro-oesophageal junction. The PD-HD operation was performed under manometric control
Receives: Other: Objective outcome; Other: Quality of life
OESOPHAGECTOMYOE was performed with open technique, or recently, with a minimally invasive technique. The stomach was always the oesophageal substitute, and the oesophagogastric anastomosis was preferably located at the thoracic dome or at the neck to minimize the risk of postoperative reflux oesophagitis or cancer growth in the residual dilated oesophagus
Receives: Other: Objective outcome; Other: Quality of life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of dysphagia severity from preoperative to 3 years after surgery

    changing of dysphagia severity from preoperative to 3 years after surgery. Dysphagia severity is evaluted according to a semiquantitative scale graded from 0 (absence) to 3 ( maximal intensity) based on Van Trappen's criteria

    Measured: 3 years

  2. change of gastroesphageal reflux symptoms from preoperative to 3 years after surgey

    change of gastroesphageal reflux symptoms from preoperative to 3 years after surgey. Severity of reflux symptoms was evaluated according to a semiquantitative scale graded from 0 (absence) to 3 ( maximal intensity) based on Van Trappen's criteria

    Measured: 3 years

  3. change quality of life from preoperative to 3 years after surgery

    change quality of life from preoperative to 3 years after surgery. The SF-36 questionnaire investigated eight specific health domains: physical functioning (PF), restrictions in activities due to physical (RP) or emotional health (RE), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and social functioning (SF). The SF-36 scores for each health domain ranged from 0 (poorer HRQL) to 100 (best HRQL).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study startJan 1987
  3. Primary completionJul 2018
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
70 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04152902
Sponsor's protocol ID
ESA
Status last verified
Nov 2019
First submitted
19 Oct 2019
Last updated
5 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Symptoms and Signs and Quality of Life, run by University of Bologna at 1 site in Italy.

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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 2019. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

change of dysphagia severity from preoperative to 3 years after surgery (time frame: 3 years). The study lists 3 primary outcomes in all. 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 5 Nov 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in