## Protocol Section
### Identification Module
**NCT ID:** NCT04333979

**Brief Title:** The Effect of Drain Use on Patient Comfort in Laparoscopic Sleeve Gastrectomy

**Official Title:** Effect of Drain Usage on Patient Comfort on Laparoscopic Sleeve Gastrectomy

#### Organization Study ID Info
**ID:** 2016-181
#### Organization
**Class:** OTHER
**Full Name:** Inonu University
### Status Module
#### Completion Date
**Date:** 2017-06-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-04-03

**Type:** ACTUAL

**Last Update Submit Date:** 2020-04-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06-22

**Type:** ACTUAL

#### Start Date
**Date:** 2016-12-09

**Type:** ACTUAL

**Status Verified Date:** 2020-04

#### Study First Post Date
**Date:** 2020-04-03
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-08
**Study First Submit QC Date:** 2020-04-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Inonu University

#### Responsible Party

**Investigator Affiliation:** Inonu University

**Investigator Full Name:** Ersin Gündoğan

**Investigator Title:** Doctor- lecturer-Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Introduction Laparoscopic sleeve gastrectomy surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

**Detailed Description:** Question the necessity of routine use of drain in Laparoscopic sleeve gastrectomy surgeon

### Conditions Module

**Conditions:**

- Obesity, Morbid

**Keywords:**

- obesity

- VAS

- Pain

- Laparoscopy

- Sleeve

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Effects of drainage

**Intervention Names:**

- Other: Drainage

**Label:** Drain replacement

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Effects of not using drain

**Label:** Drain not placed

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Drain replacement

**Description:** Using drain after operation

**Name:** Drainage

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)

**Measure:** Pain Intensity measure

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Morbid obese patients

Exclusion Criteria:

* - Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during Laparoscopic sleeve gastrectomy and those who had previously undergone obesity surgery (revision surgery) were excluded

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Obesity, Morbid

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009767

- Term: Obesity, Morbid

### Misc Info Module

- Version Holder: 2024-05-24
