Trial Outcomes & Findings for Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding (NCT NCT01564732)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

36 months

Results posted on

2016-07-01

Participant Flow

17 subjects consented to participate: 1 from Duke University and 16 from the University of Pittsburgh, 6 had not completed surgery before the study termination (2 withdrawn by the PIs and 4 were still in their pre-surgical workup). 11 participants had surgery and were randomized (per the protocol) to plicated band (PLAGB) or standard band (SLAGB).

Participant milestones

Participant milestones
Measure	Standard-LAGB Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months. Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.	Plicated-LAGB Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months. Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body \& greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.
Overall Study STARTED	6	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard-LAGB Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months. Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.	Plicated-LAGB Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months. Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body \& greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.
Overall Study Early termination by the study sponsor	6	5

Baseline Characteristics

Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard-LAGB n=6 Participants Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months. Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.	Plicated-LAGB n=5 Participants Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months. Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body \& greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.	Total n=11 Participants Total of all reporting groups
Age, Customized ≥18 to ≤60 years	6 participants n=99 Participants	5 participants n=107 Participants	11 participants n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Data not collected.

Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Data not collected

Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Data not collected.

Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Data not collected.

Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.

Outcome measures

Outcome data not reported

Adverse Events

Standard-LAGB

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Plicated-LAGB

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard-LAGB n=6 participants at risk Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months. Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.	Plicated-LAGB n=5 participants at risk Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months. Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body \& greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.
Surgical and medical procedures 3mm splenic capsular tear	0.00% 0/6	20.0% 1/5
Injury, poisoning and procedural complications Left hand laceration	0.00% 0/6	20.0% 1/5
Surgical and medical procedures 2cm abrasion of the left hepatic lobe	16.7% 1/6	0.00% 0/5
Injury, poisoning and procedural complications rotator cuff tear	0.00% 0/6	20.0% 1/5
Cardiac disorders Sinus arrhythmia	0.00% 0/6	20.0% 1/5
Cardiac disorders premature atrial contractions	0.00% 0/6	20.0% 1/5

Additional Information

Dana Portenier, M.D.

Duke University Medical Center

Phone: 919-470-7031

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place