Waiting for Stapler Firing in Laparoscopic Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Abdominal Pain and Symptoms Post Gastric Sleeve

NCT03456024

Abdominal Pain Quality of Life

UNKNOWN

Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery

NCT01560494

Surgical Education

COMPLETED NA

The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

NCT02543853

Gastrointestinal Disorder Postoperative

UNKNOWN NA

The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy

NCT03482609

Stomach Neoplasms

UNKNOWN

Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

NCT02012894

Gastroesophageal Reflux Obesity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Staple Misfire

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two equal groups with equal comorbid conditions will be compared

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Computer-assisted 4-block-based randomization via random.org

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

standby while firing staple

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

standby while firing staple

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standby 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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