## Protocol Section
### Identification Module
**NCT ID:** NCT06421857

**Brief Title:** Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma

**Official Title:** Bipolar Coagulation Versus Suturing During Laparoscopic Endometriotic Cystectomy

#### Organization Study ID Info
**ID:** ASU Hemostasis
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams Maternity Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams Maternity Hospital

#### Responsible Party

**Investigator Affiliation:** Ain Shams Maternity Hospital

**Investigator Full Name:** Nagat Hesham Abdelhai Mohammed

**Investigator Title:** postgraduate student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected

### Conditions Module

**Conditions:**

- Endometrioma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding

**Intervention Names:**

- Procedure: suturing

**Label:** suturing

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding

**Intervention Names:**

- Procedure: bipolar electrocoagulation

**Label:** bipolar electrocoagulation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- suturing

**Description:** laparoscopic cystectomy for endometrioma and hemostasis was done using suturing

**Name:** suturing

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- bipolar electrocoagulation

**Description:** laparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation

**Name:** bipolar electrocoagulation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** measuring AMH level

**Measure:** ovarian reserve

**Time Frame:** 6 weeks after procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 to 35 years
* unilateral endometriotic cyst

Exclusion Criteria:

anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Ain Shams university

**Zip:** 11566

#### Overall Officials

**Official 1:**

**Affiliation:** Ain Shams University

**Name:** Osama Kamel, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometrioma

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
