Waiting for Stapler Firing in Laparoscopic Sleeve Gastrectomy

• Sponsor: Medeni Şermet (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05703035
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Staple Misfire	Procedure: standby while firing staple	N/A

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 At the end of the operation, the gastric tube will be withdrawn, and the stomach will be filled with 120 cc saline colored with methylene blue to check if there is any leakage.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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two equal groups with equal comorbid conditions will be comparedTwo equal groups with equal comorbid conditions will be compared
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Computer-assisted 4-block-based randomization via random.org
• Primary Purpose: Prevention
• Official Title: The Effects of Waiting 1 Minute During Stapling During Laparoscopic Sleeve Gastrectomy on
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; 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.
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; 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.

Outcome Measures

Primary Outcome Measures

1. to measure that waiting a certain time before and after firing the stapler can reduce complications. [the period from the 1st day to the 1st month postoperatively will be taken as a basis.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medeni Sermet	Istanbul		Turkey

Sponsors and Collaborators

• Medeni Şermet

Investigators

• Study Director: medeni sermet, 1, goztepe prof. dr. suleyman yacin city hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medeni Şermet, specialist general surgery, Goztepe Prof Dr Suleyman Yalcın City Hospital
• ClinicalTrials.gov Identifier: NCT05703035
• Other Study ID Numbers: 2021/0530
• First Posted: Jan 27, 2023
• Last Update Posted: Jan 27, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 27, 2023