The Efficacy of External Warming During Laparoscopic Bariatric Surgery

NCT03429205 | Terminated

• 1 other identifier: 4578-17-SMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump. The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered. The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last \<2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.

Conditions

Hypothermia; Morbid Obesity; Bariatric Surgery Candidate

Keywords

Sleeve gastrectomy; Roux-Y gastric bypass; Single anastomosis gastric bypass; Hypothermia; External heating blanket

Outcome Measures

Primary Outcomes (2)

• Intraoperative core-temperature decline

  Core-temperature will be continuously measured throughout surgery

  Surgery duration, up to 2 hours from surgery start-time

• Arrival temperature at post anesthesia care unit (PACU)

  Core temperature upon arrival to recovery room

  arrival to recovery room, up to 2 h from surgery start-time

Secondary Outcomes (3)

• Hypothermia events

  3 hours from surgery start-time

• Intraoperative blood loss

  Surgery duration, up to 2 hours from surgery start-time

• Post operative complications

  30 days postoperatively

Study Arms (2)

No heating - Study group

EXPERIMENTAL

Patient will undergo bariatric surgery without utilization of external heating device.

Other: No external heating used during surgery

Heating - Control group

OTHER

Patient will undergo bariatric surgery with utilization of external heating device.

Other: External heating blanket used during surgery

Interventions

No external heating used during surgery OTHER

Deviation from external heating for all surgery standard

No heating - Study group

External heating blanket used during surgery OTHER

Standard external heating plan used in all surgery types

Heating - Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for bariatric surgery
• Surgery time estimated to be \< 2 hours

You may not qualify if:

• Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
• Surgery time estimated to be more than 2 hours

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 56261, Israel

Location

MeSH Terms

Conditions

Hypothermia; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bariatric and Metabolic Surgery, Principal Investigator

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 12, 2018
• Study Start: March 15, 2018
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)