Clinical trial NCT02272907: Leak Pressure After Reinforcement in Gastric Specimens
Official title: Comparison of Leak Pressure in the Resected Gastric Specimen From Sleeve Gastrectomy With Different Reinforcement Techniques
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Bariatric Surgery
Laparoscopy
Weight Loss Surgery
Staple Line Reinforcement
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: The purpose of this study is to evaluate the mechanical strength of various staple line reinforcement techniques using the resected portion of stomach in patients undergoing laparoscopic sleeve gastrectomy. The specimen will be collected at the time of surgery, the previous staple line will be excised, and a new staple line with one of the investigatory reinforcement procedures will be applied. The staple line techniques to be used in this study include non-buttressed and non-imbricated oversewing, non-buttressed and imbricated suture line, buttressed stapling, and no reinforcement (see protocol for description of each). The specimen will then be taken to the morgue where the experimental procedure will be performed within 6 hours of specimen procurement. The specimen will be attached to a catheter with a pressure monitor and blue dye will be instilled into the specimen until leakage is seen. The presence of leakage indicates failure of the staple line. Detailed measurements of all specimens will be performed as will leak pressure and location in the specimen where leak occurred. The specimen will then be turned over to pathology to undergo routine pathologic examination.

This experimental procedure has been used previously in published literature with animal samples, but never with human tissue. A possible reason for the lack of testing in the stomach staple line in patients after sleeve gastrectomy is that the technical aspects of bariatric surgery were developed using gastric bypass; a procedure where the stomach is divided but not excised.

The investigators hypothesize that the specimens treated with staple line buttressing material will fail at a higher pressure than those without reinforcement. The investigators will also explore the location of the failure to determine if there is a consistent site of weakness. Should this study yield consistent results, it would help determine a standard approach for staple line reinforcement after laparoscopic sleeve gastrectomy. Additionally, should the location of the leak be consistent, this information may help drive technical changes that could decrease leak rate, an infrequent but potentially devastating risk of this and other weight loss surgeries.

Eligibility criteria: Inclusion Criteria:

* Undergoing laparoscopic sleeve gastrectomy

Exclusion Criteria:

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

Primary outcomes:
measure: Bursting pressure
timeFrame: This will be measured within 6 hours of the specimen being resected from the patient.
Secondary outcomes:
measure: Most common leak site
timeFrame: This will be measured within 6 hours of the specimen being resected from the patient.
Other outcomes:
Locations:
Study officials:
References: