Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy

NCT03982823 | Completed

• 1 other identifier: 2014/33
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sleeve gastrectomy is a stapler dependent bariatric procedure. A hand-sewn sleeve gastrectomy can be necessary under certain circumstances. Here, the investigatorsaimed to compare the outcomes of hand-sewn and stapled sleeve gastrectomies for the first time. In the hand-sewn group, no staplers were used and after vertical resection of the stomach by energy devices, the remnant stomach was closed by two rows intracorporeal sutures. In the stapler group, sleeve gastrectomy was done in the usual way.

Conditions

Morbid Obesity

Keywords

morbid obesity; surgical stapling; suture techniques; natural orifice surgery; transoral; mini-laparoscopy

Outcome Measures

Primary Outcomes (2)

• Volume of intraoperative blood loss

  Intraoperative blood loss depending on duration of the operation (10-190 cc)

  Depending on duration of the operation (60-300 mins)

• Duration of the operation

  Operating time is compared between hand-sewn and stapled group

  Depending on the type of the operation (60-300 mins)

Secondary Outcomes (2)

• Length of hospital stay

  3-10 days

• Presence of postoperative complications

  3-13 days after the operation

Study Arms (2)

Hand-Sewn Sleeve Gastrectomy

EXPERIMENTAL

Procedure: Hand-Sewn Sleeve Gastrectomy

Stapled Sleeve Gastrectomy

ACTIVE COMPARATOR

Procedure: Stapled Sleeve Gastrectomy

Interventions

Hand-Sewn Sleeve Gastrectomy PROCEDURE

After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.

Hand-Sewn Sleeve Gastrectomy

Stapled Sleeve Gastrectomy PROCEDURE

Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .

Stapled Sleeve Gastrectomy

Eligibility Criteria

• Age: 21 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of morbid obesity (body mass index over 40 kg/m2)
• Bariatric surgery must be the final decision of the obesity council.

You may not qualify if:

• Patients under legal age (\<18 years)

Sponsors & Collaborators

• Inonu University: lead

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Fellow at the Department of Gastroenterology Surgery

Model Details: Stapled Sleeve Gastrectomy Group and Hand-Sewn Sleeve Gastrectomy Group

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 12, 2019
• Study Start: May 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: June 12, 2019

Record last verified: 2019-06