Waiting for Stapler Firing in Laparoscopic Sleeve Gastrectomy

NCT05703035 | Completed DMC

• 1 other identifier: 2021/0530
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Complications will be evaluated by waiting 30 seconds after firing 30 seconds during stapler compression while performing sleeve gastrectomy.

Conditions

Staple Misfire

Outcome Measures

Primary Outcomes (1)

• to measure that waiting a certain time before and after firing the stapler can reduce complications.

  There will be a waiting period of 30 seconds during stapler compression and 30 seconds after ignition. Thus, complications such as postoperative bleeding and leakage can be reduced.

  the period from the 1st day to the 1st month postoperatively will be taken as a basis.

Study Arms (2)

waiting group during staple firing

ACTIVE COMPARATOR

In this group, the amount of bleeding, bleeding points, postoperative drain amount and laboratory values will be monitored during the operation.

Procedure: standby while firing staple

staple firing group without waiting for a certain time

ACTIVE COMPARATOR

In this group, no further intervention will be made, and the same treatment will be given as the 1st group and comparison will be made.

Procedure: standby while firing staple

Interventions

standby while firing staple PROCEDURE

VOLUNTEER PATIENTS WHO ACCEPT THE SURGERY WILL HAVE TISSUE CLOSURE AND CUTTING WITH STAPLER IN AVERAGE 30 MINUTES DURING THE SURGERY AND THE PATIENT WILL BE FOLLOWED FOR 30 DAYS.

staple firing group without waiting for a certain time; waiting group during staple firing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Among the patients between the ages of 18-65 who will undergo morbid obesity operation;
• Body mass index (BMI): 35.0-39.9 and those with at least one obesity-related comorbidity
• Patients with BMI: 40.0-49.9

You may not qualify if:

• a-Applicants for revision surgery, b- Patients with a history of thromboembolism, c- Patients with known coagulation disorders

Sponsors & Collaborators

• Medeni Şermet: lead

Study Sites (1)

Medeni Sermet

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Sermet M. Compression pre-stapler firing and post-ignition wait during sleeve gastrectomy: a prospective randomized trial. Sao Paulo Med J. 2023 Dec 15;142(3):e2023163. doi: 10.1590/1516-3180.2023.0163.140823. eCollection 2023.

  PMID: 38126605 DERIVED

Study Officials

• medeni sermet, 1

  goztepe prof. dr. suleyman yacin city hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Computer-assisted 4-block-based randomization via random.org
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialist general surgery

Model Details: Two equal groups with equal comorbid conditions will be compared

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 27, 2023
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 20, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)