Leak Pressure After Reinforcement in Gastric Specimens

NCT02272907 | Withdrawn

• 1 other identifier: 14-27r
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators hypothesize that staple line reinforcement will result in a higher leak pressure than a non-reinforced staple line closure in the resected gastric specimens from laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after various staple line treatments. The investigators will also analyze the most common site of specimen leak, association of stomach thickness to leak, association of stomach thickness to performance of the staple line techniques, and a cost analysis.

Conditions

Obesity

Keywords

Bariatric Surgery; Laparoscopy; Weight Loss Surgery; Staple Line Reinforcement

Outcome Measures

Primary Outcomes (1)

• Bursting pressure

  The primary outcome will be assessed by inflating the resected stomach specimen (after staple line reinforcement and placement of pressure monitor within specimen) with a methylene blue saline solution until a leak is observed or drop in pressure on the monitor.

  This will be measured within 6 hours of the specimen being resected from the patient.

Secondary Outcomes (1)

• Most common leak site

  This will be measured within 6 hours of the specimen being resected from the patient.

Study Arms (4)

Non-buttressed, non-imbricated oversewing

EXPERIMENTAL

Along the staple line, the surgical attending will oversew the length of the staple line using a 2-0 Vicryl suture in a continuous fashion.

Other: Injection of saline solution into specimen to test bursting pressure.

Non-buttressed, imbricated suture line

EXPERIMENTAL

Along the staple line, the surgical attending will oversew the staple line using a 2-0 Vicryl suture in a continuous, imbricating fashion.

Other: Injection of saline solution into specimen to test bursting pressure.

Buttressed stapling

EXPERIMENTAL

The specimen will be stapled utilizing the same stapling device, with Seamguard applied as a buttress. We will use the standard methodology to apply Seamguard as illustrated in the company's "Instructions for Use."

Other: Injection of saline solution into specimen to test bursting pressure.

No reinforcement

ACTIVE COMPARATOR

Data will be collected on staple lines without any reinforcement as a baseline for leak pressure.

Other: Injection of saline solution into specimen to test bursting pressure.

Interventions

Injection of saline solution into specimen to test bursting pressure. OTHER

A 1 cm gastrotomy will be made with a purse-string suture placed around the defect. A fluid-instillation catheter will be inserted into the specimen via the gastrotomy. The purse-string suture will then be secured around the catheter. The catheter will be fenestrated with a flange to prevent leakage from the gastrotomy site. The catheter will be attached to a Biopac pressure-monitoring device to monitor pressure within the lumen of the specimen. The specimen will then be suspended in a water bath and methylene blue saline solution will be injected into the specimen to a pressure reading of 0. This will be time zero for our experiment. Methylene blue saline solution will then be injected steadily in incremental levels. During this process, the study team will observe for any obvious blue dye leaks at the staple line or drop in pressure on the monitor.

Buttressed stapling; No reinforcement; Non-buttressed, imbricated suture line; Non-buttressed, non-imbricated oversewing

Eligibility Criteria

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

You may qualify if:

• Undergoing laparoscopic sleeve gastrectomy

You may not qualify if:

• Undergoing a revisional procedure
• Subject whose specimens need clinical attention by pathology following resection (e.g. cancer biopsy)
• Steroid use

Sponsors & Collaborators

• Santa Barbara Cottage Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 23, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06