Minimally Invasive Collis-Nissen for the Treatment of Short Esophagus

NCT02288988 | Completed DMC

• 1 other identifier: Collis-Nissen Surgery
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastro-esophageal Reflux Diseases; Short Esophagus

Keywords

GERD; Short Esophagus; Minimally Invasive Surgery; Collis gastroplasty

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (1)

• Number of patients with satisfactory results

  up to 60 months after surgery

Study Arms (1)

GERD patients with Short Esophagus

OTHER

Patients 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).

Procedure: Antireflux Surgery

Interventions

Antireflux Surgery PROCEDURE

Collis gasytroplasty Nissen antireflux fundoplication

Also known as: Collis gastroplasty, Nissen

GERD patients with Short Esophagus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Department of Medical and Surgical Sciences University of Bologna

Bologna, Bo, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 26518379 DERIVED

Related Links

• Department of Medical and Surgical Sciences University of Bologna

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Gastroplasty; Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Sandro Mattioli, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 13, 2014
• Study Start: January 1, 1995
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

IT (1)