Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02288988 |
| Other study ID # |
Collis-Nissen Surgery |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 4, 2014 |
| Last updated |
November 7, 2014 |
| Start date |
January 1995 |
| Est. completion date |
December 2013 |
Study information
| Verified date |
November 2014 |
| Source |
University of Bologna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Italy: National Institute of Health |
| Study type |
Interventional
|
Clinical 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. 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.
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".
