CClinicalTrials.gg
CompletedNCT05703035Updated Apr 16, 2024

Waiting for Stapler Firing in Laparoscopic Sleeve Gastrectomy

An interventional study of standby while firing staple in Staple Misfire, sponsored by Medeni Şermet. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Medeni Şermet · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

Those with a BMI between 35.0 and 39.90 and those with an obesity-related comorbidity, and all morbid obesity patients with a BMI of 40.0 and above, were previously adequate for at least 6 (six) months with non-surgical (diet, medication, exercise, etc.) methods. Patients with morbid obesity who could not lose weight and who were unsuccessful will be included in the study by signing an informed consent form for the operation and study, after being evaluated by the "obesity council" consisting of endocrinology, psychiatry, anesthesiology, dietitian and general surgery, and approved for bariatric surgery. Waiting will be made for patients whose patient file number has an odd number in the last digit, and no waiting will be made for patients whose last digit is an even number. At the time of the operation, the patients will be put on thromboembolic stockings and the reverse trendelenburg position will be given and the operation will be started with the laparoscopic method. After the stomach is mobilized from the adjacent organs and structures, the 38F gastric tube will be advanced to the stomach, the tissue will be closed with a 60 mm laparoscopic stapler, waited for 30 seconds, and then ignition will be performed. After the stapler is fired, a waiting period of 30 seconds will be waited and it will be removed from the tissue. In this first case, whether there is bleeding or not, at how many points, whether additional intervention is required or not will be recorded. At the end of the operation, the gastric tube will be withdrawn, and the stomach will be filled with 120 cc saline colored with methylene blue to check if there is any leakage. If there is no leakage, a gastric drainage drain will be placed and the operation will be completed. Postoperative 24 - 48 . After discharge, the patient will be called for routine control on the 1st week, 15th day and 30th day after discharge.

02

Conditions studied

  • Staple Misfire
03

In context

Lead sponsor

Medeni Şermet is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Among the patients between the ages of 18-65 who will undergo morbid obesity operation;

    1. Body mass index (BMI): 35.0-39.9 and those with at least one obesity-related comorbidity
    2. Patients with BMI: 40.0-49.9

Exclusion criteria

Exclusion Criteria:

  • a-Applicants for revision surgery, b- Patients with a history of thromboembolism, c- Patients with known coagulation disorders
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    waiting group during staple firing

    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

  • Active comparator
    staple firing group without waiting for a certain time

    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

  • Procedurestandby while firing staple

    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.

06

What researchers measure

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.

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

07

Study locations

1 site
  • Medeni Sermet
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05703035
Lead sponsor
Medeni Şermet
Responsible party
Medeni Şermet (specialist general surgery, Goztepe Prof Dr Suleyman Yalcın City Hospital) — Sponsor-investigator
First posted
Jan 27, 2023
Start date
Jan 1, 2022
Primary completion
Feb 1, 2023
Completion
Apr 20, 2023
Last update
Apr 16, 2024

Study contacts

medeni sermet, 1
study director · goztepe prof. dr. suleyman yacin city hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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