Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hand-Sewn Sleeve Gastrectomy
Stapled Sleeve Gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring morbid obesity, surgical stapling, suture techniques, natural orifice surgery, transoral, mini-laparoscopy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of morbid obesity (body mass index over 40 kg/m2)
- Bariatric surgery must be the final decision of the obesity council.
Exclusion Criteria:
- Patients under legal age (<18 years)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hand-Sewn Sleeve Gastrectomy
Stapled Sleeve Gastrectomy
Arm Description
Outcomes
Primary Outcome Measures
Volume of intraoperative blood loss
Intraoperative blood loss depending on duration of the operation (10-190 cc)
Duration of the operation
Operating time is compared between hand-sewn and stapled group
Secondary Outcome Measures
Length of hospital stay
Postoperative length of hospital stay
Presence of postoperative complications
leakage, peritonitis, gastrointestinal haemorrhage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03982823
Brief Title
Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy
Official Title
Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy, Retrospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (undefined)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Nowadays, morbid obesity is a major health problem that the investigatorsface in every age groups. In the treatment of morbid obesity, sleeve gastrectomy is applied more and more frequently. However, sleeve gastrectomy is a stapler dependent operation and sleeve gastrectomy without the use of staplers was very limited in the literature [1]. Hand-sewn sleeve gastrectomy can rarely be necessary in some special conditions such as technical defects of the staplers, patients allergies to titanium clips or sometimes when staplers were unusable [1]. As far as the investigatorsknow, there was no study that compare the results of stapled and hand-sewn sleeve gastrectomies so far. The purpose of this study was to compare the hand-sewn and stapled sleeve gastrectomies in a small case series.
In June 2013, the investigatorslaunched a natural orifice surgery program including several procedures. In this context, the investigatorsplanned natural orifice (transoral) extraction of sleeve gastrectomy specimens. Patients who were eligible and agree with participation to the hand-sewn sleeve gastectomy combine with transoral specimen extraction study were accepted to two group. This study is conducted according to the STROCSS criteria. Total six morbidly obese patients (body mass index more than 40 kg/m2) who had undergone hand-sewn sleeve gastrectomy between the dates May-2014 and December 2014, were investigated retrospectively. In the same time period, seven another morbidly obese patients included in the control group were treated with stapled sleeve gastrectomies. Grouping was done by the acceptance of the patients. The hand-sewn sleeve gastrectomy group combined with natural orifice surgery. Patients who do not participate the hand-sewn group were treated by the stapled sleeve gastrectomy and the specimens were extracted through the trocar site. In both groups, patients' age, gender, height, weight, body mass index, comorbidity, and lifestyle properties were recorded. Intraoperative blood loss, operating time, length of hospital stay, postoperative complications, and the metabolic/bariatric results of the two groups in one and three years were evaluated. Statistical comparisons were performed with nonparametric statistical tests (Mann-Whitney U-test and Wilcoxon Signed Rank Test to analyze numerical data, and Fisher exact test to analyze cathegorical data). Numerical data expressed as median and range. P<0.05 was considered as significant.
In the hand-sewn group, following pneumoperitoneum with a Veres needle, the first 5 mm trocar was entered 14 cm down and 4 cm left from the xyphoid process. Other two 5 mm trocars were applied to the left and right upper quadrant. Last two 5 mm trocars were placed just below the xyphoid process for automatic liver retractor and through the epigastrium as a working port. A 5 mm 300 optic camera was used and the intraabdominal pressure was set to 14 mmHg. Gastrocolic and gastrosplenic ligaments were divided by 5 mm Ligasure (Force Triad, Covidien, Boulder, CO, USA) starting from 4-6 cm to pylorus till the angle of His. The greater curvature was liberated up to the left crus of the diaphragm. The anterior and posterior wall of the stomach were transected with a 5 mm Ligasure device under the guidance of a 36 F bougie, starting 4-6 cm away from the pylorus and division of both gatric leaves headed vertically in the direction of angle of His. After completion of the gastric division, the resected specimen was removed through the mouth with the help of an intraoperative peroral endoscopy using an endoscopic snare. The remaining open anterior and posterior walls of the stomach was continiously sutured each other by 3/0 polypropylene sutures. The suture length was 20 cm.
All the trocars were 5 mm in size in the hand-sewn group. The surgical technique of the stapled group has been defined in detail before (2). In short, vertical gastrectomy was applied with a 60 mm. lineer stapler (Endo GIATM Ultra, Covidien) under the guidance of 36 F bougie. These procedures were done through three 12 mm and two 5 mm trocars, that were placed to the same locations with the hand-sewn group. The specimen in the stapler group were extracted from the left upper quadrant trocar site. No supportive material or suture was use to the staple lines. Methylene blue test was done and a drain was place in all case.
After 6-8 hours postoperatively, the patients were mobilized, thromboembolic stockings were kept for five days. A liquid diet was started on day one. Prophylaxis of deep vein thrombosis was continued for 15 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
morbid obesity, surgical stapling, suture techniques, natural orifice surgery, transoral, mini-laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stapled Sleeve Gastrectomy Group and Hand-Sewn Sleeve Gastrectomy Group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand-Sewn Sleeve Gastrectomy
Arm Type
Experimental
Arm Title
Stapled Sleeve Gastrectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hand-Sewn Sleeve Gastrectomy
Intervention Description
After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.
Intervention Type
Procedure
Intervention Name(s)
Stapled Sleeve Gastrectomy
Intervention Description
Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .
Primary Outcome Measure Information:
Title
Volume of intraoperative blood loss
Description
Intraoperative blood loss depending on duration of the operation (10-190 cc)
Time Frame
Depending on duration of the operation (60-300 mins)
Title
Duration of the operation
Description
Operating time is compared between hand-sewn and stapled group
Time Frame
Depending on the type of the operation (60-300 mins)
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Postoperative length of hospital stay
Time Frame
3-10 days
Title
Presence of postoperative complications
Description
leakage, peritonitis, gastrointestinal haemorrhage
Time Frame
3-13 days after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of morbid obesity (body mass index over 40 kg/m2)
Bariatric surgery must be the final decision of the obesity council.
Exclusion Criteria:
Patients under legal age (<18 years)
12. IPD Sharing Statement
Learn more about this trial
Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy
We'll reach out to this number within 24 hrs