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Gastro-esophageal Reflux DiseasesCOLLIS-NISNCT02288988

Minimally Invasive Collis-Nissen for the Treatment of Short Esophagus

A study testing Antireflux Surgery in people with Gastro-esophageal Reflux Diseases and Short Esophagus, 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
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Trial summary

True short esophagus (TSE) is present when the distance between the esophago-gastric (E-G) junction and the apex of the hiatus is shorter than 2.5 cm, without the application of any downward pressure on the stomach, after maximal mobilization of the distal thoracic esophagus. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Antireflux Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteItaly
Study dates
Jan 1995to Dec 2013
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

  • Patients aged > 18 years with severe GERD symptoms and esophagitis associated with short esophagus

Who cannot join

  • Patients aged < 18 years Patients aged > 18 years with sliding hiatal hernia

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Department of Medical and Surgical Sciences University of Bologna

    Bologna, Bo, 40138

Other trials in Italy

About this study

Official title: Results of the Minimally Invasive Collis-Nissen Technique for the Treatment of True Short Esophagus

True short esophagus (TSE) is present when the distance between the esophago-gastric (E-G) junction and the apex of the hiatus is shorter than 2.5 cm, without the application of any downward pressure on the stomach, after maximal mobilization of the distal thoracic esophagus. It has been demonstrated that TSE is present in 20% of patients undergoing routine surgery for gastro-esophageal reflux disease (GERD), and in more than 50% of cases of type III-IV hiatal hernia (HH) that are treated surgically. Recent reports have confirmed the importance of diagnosing and electively treating TSE to reduce the risk of anatomic recurrence after surgery. The surgical techniques currently used for the elective treatment of TSE are based on the association of the Collis gastroplasty with an anti-reflux funduplication and the hiatoplasty, performed using minimally invasive techniques; the mortality, morbidity, and outcomes of these procedures remain subjects of debate. In light of the doubtful validity of the surgical results for TSE, some researchers have proposed that this condition should not be treated with surgical therapy. In the absence of randomized, multicenter studies designed to compare the surgical techniques used to treat TSE, the investigators believe that data obtained from a single-center study may be useful to the surgical community, provided that such data are based on an objective intra-operative diagnosis of TSE and a rigorous follow-up period.

Read the detailed description

The pre-operative evaluation included a clinical interview, a barium swallow study, an upper gastro-intestinal (GI) endoscopy, and standard manometry. The type and severity of symptoms and the grade of reflux esophagitis were determined using a questionnaire with semi-quantitative scales.

The barium swallow study was performed to define the position of the E-G junction with respect to the diaphragm with the patient in the upright position, as well as the morphology and the type of HH. The migration of the E-G junction was radiologically diagnosed in three steps using the following differential diagnoses: hiatal insufficiency, concentric HH, and acquired short esophagus. Reflux esophagitis was classified according to the Los Angeles classification. In the absence of grade A esophagitis or a more severe type of esophagitis, patients underwent 24-h pH recording or intraluminal impedance/pH monitoring. The need for surgical therapy was determined according to defined parameters and to the current guidelines for GERD therapy.

The patient is placed in the lithotomic position; the pelvis and left chest are lifted 45° to the right to facilitate access for a left thoracostomy along the posterior axillary line.

Surgery begins via five laparoscopic ports: the camera port is placed 5 to 10 cm above the umbilicus, depending on the patient's body size, to enable access to the upper portion of the mediastinum. After the opening of the phreno-esophageal membrane, the E-G junction is isolated and the sac and fat pad (with the exception of the fat near the lesser curvature to preserve the integrity of the vagus nerves) are resected. A fiber endoscope is inserted trans-orally to determine the position of the upper margins of the gastric folds, which correspond to the E-G junction. The tip of the endoscope is placed at this level, which the surgeon marks with two clips. The intra-thoracic esophagus is mobilized by 9-12 centimeters to the level at which the left vagus nerve travels along the anterior aspect of the esophagus.

The distance between the E-G junction and the apex of the hiatus is measured after completely releasing the stomach, using an L-shaped instrument, which prevents errors associated with the two-dimensional video image. The upper arm of the L (90° based on the axis of the measurer) is placed at the apex of the diaphragm, and the distance between the base of the arm and the clip is measured in centimeters; the measurement is positive if the junction is above and negative if the junction is below the diaphragm. The length of the intra-abdominal portion of the esophagus that is suitable for the performance of a tension-free fundoplication is approximately 2.5 cm. If the E-G junction, with the stomach completely released, is still fixed above or astride the hiatus, the Collis technique is adopted. If the E-G junction is positioned below the hiatus by only 1-1.5 cm, a scenario in which even the application of slight downward traction on the stomach makes it possible to obtain the 2-3 cm of esophagus necessary to perform the fundoplication, its position creates a condition in which the decision of whether to perform a Collis gastroplasty becomes subjective. In such cases, the investigators generally perform the lengthening procedure if reflux symptoms have been present for many years, if the patient is obese, or if the patient is younger than 60 years. To perform the esophagus lengthening procedure, it is necessary to divide at least two short vessels. By turning the operating table toward the right side of the patient, the surgeon may simultaneously operate through the aforementioned 5 standard laparoscopic ports, as well as a left thoracoscopic port through which the instrument used to lengthen the esophagus is inserted. A thoracostomy is performed at the posterior axillary line at the V-VI-VII intercostal spaces, depending on the patient's body shape and size. A 12-mm valvular trocar may be used to prevent loss of pneumoperitoneum and to control intra-thoracic pressures.

The anesthesiologist passes a Maloney bougie 46 ch. into the esophagus and into the proximal stomach.

A no. 45 Endo GIA is inserted through the thoracic port; the tip of the instrument is delicately pressed against the left diaphragm to visually control the progression of the stapler from the port to the mediastinum. The stapler is fully visible through the hiatus as it penetrates the left mediastinal pleura. When it enters the abdominal cavity, the jaws are rotated toward the patient's left side.

The stapler is opened and positioned at the angle of His with its arms parallel but not too close to the Maloney bougie. To facilitate this maneuver and prevent the formation of a pouch between the suture lines and the angle of His, it may be necessary to pull the gastric fundus to the left when using the stapler.

The neo-esophagus is approximately 3 cm long. The mechanical suture line is covered with a sero- muscular running suture. A hiatoplasty is routinely performed; in the event of a type II-IV HH, the sutures applied to the diaphragmatic crura are reinforced with polytetrafluoroethylene-pledgeted sutures (two for each stitch, placed laterally at the edges of the crura and over the peritoneum). A floppy Nissen fundoplication (one 1.5-cm U stitch reinforced with pledgets) is performed. The superior edges of the fundoplication are placed above the clips, which mark the native E-G junction, to fully wrap the neo-esophagus. Two vertical U stitches intended to grab the inner, circular, muscular layer are applied laterally between the fundus and the esophagus to prevent slippage.

Follow-Up

Post-operatively, each of the patients participated in a free-of-charge outpatient follow-up program that entailed visits at 6 months, 12 months, and 2, 3, 4, and 5 years following surgery. At 1, 3, and 5 years, patients participated in a clinical interview and underwent both an upper GI endoscopy and a barium swallow study. The methodologies of these tests were the same as those used for the pre-operative work-up. Following the initial five-year follow-up period, patients were offered the opportunity to attend an outpatient clinical consultation every 3 years, as well as to undergo an endoscopy and a radiological examination of the esophagus and stomach. The follow-up procedures were established according to the "good practice criteria" accepted by the Italian Health Service. Patients voluntarily agreed to participate in the program. The length of the follow-up was calculated based on the amount of time that elapsed between the date of each patient's surgery and the day on which each patient appeared for the final follow-up visit.

An evaluation scale for the surgical results, from "excellent" to "poor" was used.

The results of cases in which a recurring HH was diagnosed by barium swallow, even an HH smaller than two centimeters, as well as those of cases in which medical therapy (H2 blockers or proton pump inhibitors) was necessary to control reflux symptoms or esophagitis, were classified as "poor".

Being tested
Antireflux Surgery
Keywords
GERD, Short Esophagus, Minimally Invasive Surgery, Collis gastroplasty
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • Antireflux SurgeryProcedure or surgery

    Also called Collis gastroplasty, Nissen

    Collis gasytroplasty Nissen antireflux fundoplication

Study groups in NCT02288988
Study groupRoleWhat they receive
GERD patients with Short EsophagusOtherPatients with True Short Esophagus diagnosed intra-operatively: The length of the intra-abdominal portion of the esophagus < 2.5 cm measured intra-operatively using a combined endoscopic-laparoscopic method. Minimally invasive antireflux surgery was performed (Collis gastroplasty + Nissen fundoplication).
Receives: Procedure: Antireflux Surgery

What is being measured

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

  1. Number of patients with satisfactory results (Change from Baseline in the evaluation of symptoms and esophagitis at 12 months after surgery.

    participants will be followed during the follow-up 12 months after surgery. 12 months after surgery the partecipants will perform clinical interview, upper gastrointestinal endoscopy and barium swallow

    Measured: 12 months

Secondary outcomes (1)
  1. Number of patients with satisfactory results

    participants will be followed during the follow-up 60 months after surgery. 60 months after surgery partecipants will perform clinical interview, upper gastrointestinal endoscopy and barium swallow

    Measured: up to 60 months after surgery

Timeline

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

  1. First posted13 Nov 2014 (estimated)
  2. Study startJan 1995
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02288988
Sponsor's protocol ID
Collis-Nissen Surgery
Acronym
COLLIS-NIS
Status last verified
Nov 2014
First submitted
4 Nov 2014
Last updated
13 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Lugaresi M, Mattioli B, Perrone O, Daddi N, Di Simone MP, Mattioli S. Results of left thoracoscopic Collis gastroplasty with laparoscopic Nissen fundoplication for the surgical treatment of true short oesophagus in gastro-oesophageal reflux disease and Type III-IV hiatal hernia. Eur J Cardiothorac Surg. 2016 Jan;49(1):e22-30. doi: 10.1093/ejcts/ezv381. Epub 2015 Oct 29.

    PubMed 26518379

Questions about this trial

What is this clinical trial studying?

A study testing Antireflux Surgery in people with Gastro-esophageal Reflux Diseases and Short Esophagus, 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 1 inclusion and 1 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 13 Nov 2014. 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?

Number of patients with satisfactory results (Change from Baseline in the evaluation of symptoms and esophagitis at 12 months after surgery. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02288988, which also lists 1 linked publication.

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 13 Nov 2014.

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