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Impact of ERAS in LSG (ERAS-LSG)

U

Umraniye Education and Research Hospital

Status

Unknown

Conditions

Laparoscopic Sleeve Gastrectomy
Vomiting, Postoperative
Pain, Postoperative
Enhanced Recovery After Surgery
Nausea, Postoperative

Treatments

Other: ERAS

Study type

Interventional

Funder types

Other

Identifiers

NCT04442568
ERAS-LSG

Details and patient eligibility

About

Patients with BMI >35 and chronic diseases or BMI >40 will be scheduled to receive Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG. Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are determined for ERAS. All patients will be checked for status of pain with VAS score, nausea and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral intake will be started in the morning of postoperative first day. The patients who provides discharge criterias will be discahrged. these criterias are; To provide adequate pain relief with paracetamol and nonsteroidal painkillers, No wound problem, No complications after surgery, Pulse rate <90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, <20 breaths / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.

Emergency admissions of the participants within a month after surgery will be recorded.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • must be performed laparoscopic sleeve gastrectomy
  • body mass index > 35 with a comorbidıty or ,body mass index > 40

Exclusion criteria

  • surgery with peroperative complication
  • revision surgery applications

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

ERAS
Active Comparator group
Description:
all patients in this group will be performed LSG under a specified anesthesia protocol. This protocol includes non-opioid analgesia and sedation. Also short-acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the second hour postoperatively, also will be started oral intake between second and fourth hours.
Treatment:
Other: ERAS
no ERAS
No Intervention group
Description:
all patients in this group will be performed LSG under a conventional anesthesia protocol which is depended on the anesthesiologist . This protocol includes opioid analgesia and sedation. Also short and long acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the fourth hour postoperatively, also will be started oral intake in the next day morning after surgery.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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