## Protocol Section
### Identification Module
**NCT ID:** NCT02731079

**Brief Title:** Sleeve Gastrectomy Outcomes With Different Stapling Devices

**Official Title:** Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices

#### Organization Study ID Info
**ID:** WB16-08
#### Organization
**Class:** FED
**Full Name:** William Beaumont Army Medical Center
### Status Module
#### Completion Date
**Date:** 2021-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-11-06

**Type:** ACTUAL

**Last Update Submit Date:** 2018-11-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2020-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-01-22

**Type:** ACTUAL

**Status Verified Date:** 2018-11

#### Study First Post Date
**Date:** 2016-04-07
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-30
**Study First Submit QC Date:** 2016-04-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** William Beaumont Army Medical Center

#### Responsible Party

**Investigator Affiliation:** William Beaumont Army Medical Center

**Investigator Full Name:** Eric P Ahnfeldt

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this study is to compare intraoperative characteristics, such as time to create sleeve, intraoperative bleeding, and time needed to load each cartridge, and post-operative characteristics, such as any complication requiring readmission (leak or hemorrhage), further surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy with Covidien devices and Ethicon devices. Currently the investigators predominantly use whatever device is cheaper, but cost should not be the primary decisive factor if one device is superior to the other. If one device has better clinical outcomes, it should be the preferred device regardless of cost. If neither proves superiority, the investigators can justify using cost to determine which device to use in patient care.

**Detailed Description:** New bariatric patients who have elected for a sleeve gastrectomy as part of standard of care will be invited to participate in the study during the bariatric clinic at William Beaumont Army Medical Center. Patients who meet the inclusion criteria will be invited to participate in the study. These patients will be consented in the bariatric clinic by a research coordinator (Doreen Bandari-Spaulding) or physician listed on the study if the coordinator is unavailable.

Three folders will be made, one for each bariatric surgeon, and 25 Covidien cards and 25 Ethicon cards will be placed into each for a total of 150 patients. All bariatric surgeons are trained and familiar with both devices. Once consented, a card will be removed at random to determine which stapler will be used. Bioabsorbable staple line reinforcement will be utilized with both staplers. Once in the operating room, the case start time, time from first staple firing to completion of sleeve, total stapler loads required, number of staple misfires, character of any staple line bleeding, and time for tech to load each cartridge will be recorded on a data collection sheet by a research resident, listed as an associative investigator on this protocol. The subject's post-operative course will follow the bariatric protocol. During follow-up, they will be monitored for weight loss, post-operative complications, and any other required interventions. This information will be obtained by reviewing the subject's medical record after follow-up appointments. Per the institutional bariatric protocol, subjects will follow-up at 3 weeks, 6 weeks, 3 months, 6 months, and annually. If a subject withdraws consent for the study prior to surgery, they will still receive surgery and perioperative treatment in line with institutional protocol, and they will be withdrawn and create a vacancy for a new subject. If a subject withdraws consent after surgery, data collection will cease for that subject. The investigators will clarify whether they want all data to be removed from the study or if they simply want no more data to be entered into the study and abide by their wishes, and they will remain in the original randomized group in accordance with intention-to-treat principles.

### Conditions Module

**Conditions:**

- Morbid Obesity

**Keywords:**

- Sleeve gastrectomy stapler Covidien Ethicon bleeding leak

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement.

**Intervention Names:**

- Device: Covidien iDrive

**Label:** Covidien

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement.

**Intervention Names:**

- Device: Ethicon Echilon

**Label:** Ethicon

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Covidien

**Description:** Surgery performed with Covidien powered stapler

**Name:** Covidien iDrive

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Ethicon

**Description:** Surgery performed with Ethicon powered stapler

**Name:** Ethicon Echilon

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Time to create sleeve

**Time Frame:** Time from first staple firing to last staple firing, for up to 5 hours

**Measure:** Percent of staple firings with technical difficulties

**Time Frame:** Time from first staple firing to last staple firing, for up to 5 hours

**Measure:** Time to load staple cartridges

**Time Frame:** Time from first staple firing to last staple firing, for up to 5 hours

#### Secondary Outcomes

**Description:** Will note any incidental bleeding along staple line and how many maneuvers were needed to control it. Measured as: 1) None, 2) Single therapy, 3) Multiple therapy (Any combination of hemostatic modalities)

**Measure:** Intra-operative staple line bleeding

**Time Frame:** Time from first staple firing to end of the case, for up to 5 hours

**Measure:** Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year

**Time Frame:** Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation

**Measure:** Staple line leak rates

**Time Frame:** Immediate post-operative period to conclusion of study, for up to 5 hours

**Description:** Will note reason for readmission

**Measure:** Hospital readmissions or emergency room visits

**Time Frame:** Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation

**Description:** Will note intervention required and indication; reasons include, but are not limiting to, staple line leak, hematoma, abscess, prolonged tachycardia suspicious for intra-abdominal pathology

**Measure:** Sleeve-related complications requiring surgery, recorded as yes or no

**Time Frame:** Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Informed consent obtained and signed from each subject
2. Age ≥ 18 years
3. Requirement for agreement to avoid conception
4. BMI \>40
5. BMI \>35 with obesity-related co-morbidity
6. Pre-operative psychiatric evaluation
7. Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity
8. Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy

Exclusion Criteria:

1. Pregnancy- Patients are not eligible for bariatric surgery, and if they become pregnant after surgery, they would present confounding variables and alter weight loss
2. Tobacco use within one month of surgery or any time within study period- Most staff will not perform bariatric surgery on active smokers as it negatively impacts healing
3. Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications
4. Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results
5. Active duty military- Not eligible for bariatric surgery

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chelsey.a.mckinnon.mil@mail.mil

**Name:** Chelsey A McKinnon, MD

**Phone:** 915 742 2282

**Role:** CONTACT

**Contact 2:**

**Email:** daniel.j.roubik.mil@mail.mil

**Name:** Daniel J Roubik, MD

**Phone:** 915-742-2282

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** El Paso

**Contacts:**

***Contact 1:***

- **Email:** eric.p.ahnfeldt.mil@mail.mil

- **Name:** Eric P Ahnfeldt, DO

- **Phone:** 915-742-4442

- **Role:** CONTACT

***Contact 2:***

- **Email:** cara.l.reitz.mil@mail.mil

- **Name:** Cara L Reitz, MD

- **Phone:** 5617045490

- **Role:** CONTACT

**Country:** United States

**Facility:** William Beaumont Army Medical Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 79934

#### Overall Officials

**Official 1:**

**Affiliation:** Residency Program Director

**Name:** Eric P Ahnfeldt, DO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

**PMID:** 24570244

**Citation:** Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21.

**PMID:** 23177371

**Citation:** Marceau P, Hould FS, Simard S, Lebel S, Bourque RA, Potvin M, Biron S. Biliopancreatic diversion with duodenal switch. World J Surg. 1998 Sep;22(9):947-54. doi: 10.1007/s002689900498.

**PMID:** 9717420

**Citation:** Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000 Dec;10(6):514-23; discussion 524. doi: 10.1381/096089200321593715.

**PMID:** 11175958

**Citation:** Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003 Dec;13(6):861-4. doi: 10.1381/096089203322618669.

**PMID:** 14738671

**Citation:** ASMBS Clinical Issues Committee. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012 May-Jun;8(3):e21-6. doi: 10.1016/j.soard.2012.02.001. Epub 2012 Feb 10. No abstract available.

**PMID:** 22417852

**Citation:** D'Ugo S, Gentileschi P, Benavoli D, Cerci M, Gaspari A, Berta RD, Moretto C, Bellini R, Basso N, Casella G, Soricelli E, Cutolo P, Formisano G, Angrisani L, Anselmino M. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Dis. 2014 May-Jun;10(3):450-4. doi: 10.1016/j.soard.2013.10.018. Epub 2013 Nov 12.

**PMID:** 24448100

**Citation:** Gentileschi P, Camperchioli I, D'Ugo S, Benavoli D, Gaspari AL. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc. 2012 Sep;26(9):2623-9. doi: 10.1007/s00464-012-2243-2. Epub 2012 Mar 23.

**PMID:** 22441975

**Citation:** Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg. 2013;11(4):286-9. doi: 10.1016/j.ijsu.2013.02.015. Epub 2013 Feb 28.

**PMID:** 23459188

**Citation:** Sroka G, Milevski D, Shteinberg D, Mady H, Matter I. Minimizing Hemorrhagic Complications in Laparoscopic Sleeve Gastrectomy--a Randomized Controlled Trial. Obes Surg. 2015 Sep;25(9):1577-83. doi: 10.1007/s11695-015-1580-3.

**PMID:** 25596939

**Citation:** Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):713-23. doi: 10.1016/j.soard.2014.01.016. Epub 2014 Jan 28.

**PMID:** 24745978

**Citation:** Huang R, Gagner M. A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2360-7. doi: 10.1007/s11695-015-1705-8.

**PMID:** 26024735

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Morbid Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009767

- Term: Obesity, Morbid

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-02-16

##### Submission Infos

- MCP Release N: 2

- Release Date: 2024-02-16

- Reset Date: 2024-03-13

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
