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ObesityLSGNCT01974388

Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy

A study testing LSG started 2 cm from the pylorus and LSG started 6 cm from pylorus in people with Obesity, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by both restrictive and hormonal action. Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity
What is being tested?
LSG started 2 cm from the pylorus and LSG started 6 cm from pylorus
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteEgypt
Study dates
Jan 2008to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG)

Who cannot join

  • patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ayman El Nakeeb

    Al Mansurah, Mansoura, 35111

Other trials in Egypt

About this study

Official title: Impact of Extent of Antral Resection on Surgical Outcomes of Sleeve Gastrectomy for Morbid Obesity (A Prospective Randomized Study)

Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by both restrictive and hormonal action.

Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

Read the detailed description

This prospective randomized study was designed to compare between the beginning of sleeve gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative problems, weight loss, improvement of comorbidities, postoperative complications, nutritional and elemental deficiencies.

Consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG) at the department of general surgery, Mansoura University, Egypt, during the period from January 2008 to January 2012, were eligible for the study. The exclusion criteria included patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.

The operation was done under general anesthesia. Patient was in supine position with splitting of the operating table legs.Gastric transection started 2 cm proximal to the pylorus using 60 mm, green endo-stapler (Ethicon, USA) (GI) or 6 cm from the pylorus (G II). The following staplers were placed approximately 1 cm from the bougie in the direction of the gastroesophageal junction.

Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

Conditions
Obesity
Being tested
LSG started 2 cm from the pylorus, LSG started 6 cm from pylorus
Keywords
Bariatric surgery, sleeve gastrectomy, gastric leak
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LSG started 2 cm from the pylorusProcedure or surgery

    Also called Group I

    Laparoscopic sleeve gastrectomy started 2 cm from pylorus

  • LSG started 6 cm from pylorusProcedure or surgery

    Also called Group II

    LSG started 6 cm from pylorus

Study groups in NCT01974388
Study groupRoleWhat they receive
LSG started 2 cm from the pylorusActive comparatorlaparoscopic sleeve gastrectomy starting 2 cm from the pylorus
Receives: Procedure: LSG started 2 cm from the pylorus
LSG started 6 cm from pylorusActive comparatorLSG started 6 cm from pylorus
Receives: Procedure: LSG started 6 cm from pylorus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percent of excess weight loss

    The percent of EWL was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100.

    Measured: one year postoperative

Secondary outcomes (4)

  1. length of postoperative stay

    length of postoperative stay

    Measured: 30 days

  2. postoperative complications

    gastric leakage, internal haemorrhage, pulmonary complications). Complications were graded according to their severity on a validated five point scale using Dindo-Clavien complication classification system) into (grades I, II, IIIa-b, IVa-b, V). Grade I (no need for specific intervention), grade II (need for drug therapy such antibiotics, blood transfusion, total parenteral nutrition), grade IIIa-b (need for invasive therapy radiological, endoscopic or surgical), grade IVa-b (organ dysfunction requiring ICU stay and management), grade V (death)

    Measured: one year postoperative

  3. weight regain

    an increase of body weight of more than 10 kg from the nadir

    Measured: one year postoperative

  4. Resolution of comorbidity

    Resolution of comorbidity was considered if the disease is controlled without any medications.

    Measured: one year postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974388
Sponsor's protocol ID
Morbid Obesity
Acronym
LSG
Status last verified
Jan 2008
First submitted
26 Oct 2013
Last updated
23 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ferrer-Marquez M, Belda-Lozano R, Ferrer-Ayza M. Technical controversies in laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jan;22(1):182-7. doi: 10.1007/s11695-011-0492-0.

    PubMed 21861236

  • Pomerri F, Foletto M, Allegro G, Bernante P, Prevedello L, Muzzio PC. Laparoscopic sleeve gastrectomy--radiological assessment of fundus size and sleeve voiding. Obes Surg. 2011 Jul;21(7):858-63. doi: 10.1007/s11695-010-0255-3.

    PubMed 20730606

  • Shi X, Karmali S, Sharma AM, Birch DW. A review of laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg. 2010 Aug;20(8):1171-7. doi: 10.1007/s11695-010-0145-8.

    PubMed 20379795

  • Sanchez-Santos R, Masdevall C, Baltasar A, Martinez-Blazquez C, Garcia Ruiz de Gordejuela A, Ponsi E, Sanchez-Pernaute A, Vesperinas G, Del Castillo D, Bombuy E, Duran-Escribano C, Ortega L, Ruiz de Adana JC, Baltar J, Maruri I, Garcia-Blazquez E, Torres A. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg. 2009 Sep;19(9):1203-10. doi: 10.1007/s11695-009-9892-9. Epub 2009 Jul 2.

    PubMed 19572113

  • Abdallah E, El Nakeeb A, Youssef T, Abdallah H, Ellatif MA, Lotfy A, Youssef M, Elganash A, Moatamed A, Morshed M, Farid M. Impact of extent of antral resection on surgical outcomes of sleeve gastrectomy for morbid obesity (a prospective randomized study). Obes Surg. 2014 Oct;24(10):1587-94. doi: 10.1007/s11695-014-1242-x.

    PubMed 24728866

Questions about this trial

What is this clinical trial studying?

A study testing LSG started 2 cm from the pylorus and LSG started 6 cm from pylorus in people with Obesity, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percent of excess weight loss (time frame: one year postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01974388, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.

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