30-Days Post-Operative Complications in Bariatric Surgery

NCT ID: NCT04779723

Last Updated: 2021-03-03

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-13

Study Completion Date

2019-10-12

Brief Summary

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comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)

Detailed Description

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Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan . Half of the people in this world consider themselves overweight or obese. Obesity is challenging to control by medical therapy and drug treatment. The most effective way to treat obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold standard" bariatric surgical procedure. Recently there is much attention gained by laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative study to compare the early post-op complications of LSG with LRYGB technique in patients undergoing bariatric surgery.

Conditions

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Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LRYGB Procedure

LRYGB technique was performed by placing 4 to 6 trocars, a 150 cm ante-colic Roux-limb gastric pouch (30 to 50 ml) was created with linear stapled or circular stapled gastro-jejunostomy, a 50-cm long biliopancreatic limb was chosen. A passive drainage was kept near to the gastro-jejunostomy.

Group Type ACTIVE_COMPARATOR

Comparison of two Techniques of bariatric surgery

Intervention Type PROCEDURE

We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB

LSG Procedure

35 Fr bougie was used for the calibration of a gastric tube. 3 to 6 cm of longitudinal incision of the stomach was done at pylorus to the angle of His. Using of absorbable suture, the staple line was sewn.

Group Type ACTIVE_COMPARATOR

Comparison of two Techniques of bariatric surgery

Intervention Type PROCEDURE

We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB

Interventions

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Comparison of two Techniques of bariatric surgery

We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients of age 18 to 65 years
* body mass index (BMI) \>35 kg/m2 (Morbidly obese)
* Patients with failed conservative treatment of weight control

Exclusion Criteria

* Severe indicative gastroesophageal reflux disease (GERD)
* Conversion of another bariatric procedure
* Large hiatal hernia
* Patients with inflammatory bowel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Multan Medical And Dental College

OTHER

Sponsor Role lead

Responsible Party

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Manzar Ali

Consultant General and laparoscopic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Multan Medical and Dental College

Multan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Gallagher EJ, LeRoith D, Karnieli E. The metabolic syndrome--from insulin resistance to obesity and diabetes. Endocrinol Metab Clin North Am. 2008 Sep;37(3):559-79, vii. doi: 10.1016/j.ecl.2008.05.002.

Reference Type BACKGROUND
PMID: 18775352 (View on PubMed)

Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.

Reference Type BACKGROUND
PMID: 30253139 (View on PubMed)

Siddiqui M, Hameed R, Nadeem M, Mohammad T, Simbak N, Latif A, et al. Obesity in Pakistan; current and future perceptions. J Curr Trends Biomed Eng Biosci. 2018;17:001-004

Reference Type BACKGROUND

Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, Strong MB, Vinik R, Wanner NA, Hopkins PN, Gress RE, Walker JM, Cloward TV, Nuttall RT, Hammoud A, Greenwood JL, Crosby RD, McKinlay R, Simper SC, Smith SC, Hunt SC. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012 Sep 19;308(11):1122-31. doi: 10.1001/2012.jama.11164.

Reference Type BACKGROUND
PMID: 22990271 (View on PubMed)

Suter M, Donadini A, Romy S, Demartines N, Giusti V. Laparoscopic Roux-en-Y gastric bypass: significant long-term weight loss, improvement of obesity-related comorbidities and quality of life. Ann Surg. 2011 Aug;254(2):267-73. doi: 10.1097/SLA.0b013e3182263b66.

Reference Type BACKGROUND
PMID: 21772127 (View on PubMed)

Li K, Gao F, Xue H, Jiang Q, Wang Y, Shen Q, Tian Y, Yang Y. Comparative study on laparoscopic sleeve gastrectomy and laparoscopic gastric bypass for treatment of morbid obesity patients. Hepatogastroenterology. 2014 Mar-Apr;61(130):319-22.

Reference Type BACKGROUND
PMID: 24901132 (View on PubMed)

Peterli R, Borbely Y, Kern B, Gass M, Peters T, Thurnheer M, Schultes B, Laederach K, Bueter M, Schiesser M. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Ann Surg. 2013 Nov;258(5):690-4; discussion 695. doi: 10.1097/SLA.0b013e3182a67426.

Reference Type BACKGROUND
PMID: 23989054 (View on PubMed)

Other Identifiers

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MMDC-2018-023

Identifier Type: -

Identifier Source: org_study_id

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