The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts.

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts: Randomization Clinical Trial

The aim of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.

Study Overview

• Status: Unknown
• Conditions: Ovarian Endometrioma; Ovary Cyst
• Intervention / Treatment: Procedure: The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts:

Detailed Description

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecologic sur¬geons . However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. A great deal of evidence supports that the re¬moval of ovarian cysts is associated with injury to the ovarian reserve . Many of these studies involved patients who required assisted reproduction, and they found that the number both of follicles and retrieved oocytes obtained in the operated gonad during ovarian hyperstimulation was markedly reduced when compared with the contralateral intact ovary. However, most of these studies applied ovarian response to gonadotropin hyperstimulation to measure the ovarian reserve. It has been argued that these patients are not representative of all patients undergoing laparoscopic ovarian cystectomy in terms of ovarian damage because these data were acquired from aggressive gonadotropin stimulation which is thought to be different from a natural menstrual cycle .

On the other hand, because ovarian reserve cannot be mea¬sured directly, the evaluation of ovarian reserve is difficult to carry out. The induction of ovarian hyperstimulation in an un¬selected population of surgical patients for the purpose of evaluating ovarian reserve is obviously ethically untenable. The serum level of follicle-stimulating hormone (FSH) is a predictor of functional ovarian reserve , but its usefulness is limited considering that the vast majority of patients un¬dergo monolateral excision of a cyst and the contralateral in¬tact gonad may completely substitute for reduced function of the operated ovary . Given the well-established role of ul¬trasound scanning in the diagnosis and follow-up of ovarian cysts, reported that basal antral follicle number and mean ovarian diameter could be used as indicators of ovarian reserve. found that the value of ovarian stromal blood flow velocity was an initial marker of ovarian reserve before the change of FSH level and ovarian volume.

With the combined use of serum hormonal evaluation and ultrasound examination, the investigators prospectively investigated the ovarian reserve of patients after the excision of benign ovarian cysts. The damage to ovarian reserve was evaluated during through a 12-month follow-up period after the application of bipolar, ultrasonic scalpel electrocoagulation or suture for ovarian cystectomy .

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Nagib, MD; Phone Number: +201001403138
• Study Contact Backup: Name: Kareem Labib, MD; Phone Number: +201005115380; Email: kareem_labib@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 1156
    • Ain shams university maternity hospital
    • Contact: ahmed Nagib, MD; Phone Number: 00201001403138
    • Contact: Kareem Labib, MD; Phone Number: 00201005115380; Email: kareem_labib@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age: 20-35 years.
2. Uni-bilateral ovarian cyst(s) size without clinical and sonographic suspicion of ovarian cancer.
3. Regular menstrual cycles defined as a cycle length between 25 and 35 days in the 6 months before surgery.
4. Agreement to be enrolled in the study.
5. Endometriosi.
6. Renal disesase.
7. Liver disease.

Exclusion Criteria:

• 1- Prior ovarian surgery 2- Surgical necessity to perform adnexectomy 3- Known endocrine disease 4- Postoperative pathologic diagnosis that was not benign ovarian cyst 5- Oral contraceptive use before surgery last two months. 6-Addison disease. 7.Thyroid disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Laparascopy comper with coagulation and without coagulation

Procedure: The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts: Randomization Randomization will be conducted using computer generated table. Group A (48 CASES) without coagulation Group A 6 89 92 35 1 15 21 16 60 49 53 91 34 5 94 64 88 58 7 33 8 75 29 56 10 23 37 19 32 71 55 84 36 77 50 2 46 70 82 9 51 54 72 18 25 31 14 63 Group B (48 CASES) with coagulation Group B 79 38 93 43 52 44 62 47 68 76 86 95 81 83 42 80 94 30 78 61 12 17 66 13 41 59 22 73 39 65 4 90 28 26 3 87 40 85 69 48 27 24 74 57 11 20 67 45 Allocation and concealment Nineteen six opaque envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table then all envelopes will be closed and put in one box. When the first patient arrives the first envelope will be opened and the patient will be allocated according to the letter inside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial	Laparascopy without coagulation excision of ovarian cysts and effect of ovarian reserve RESULIT The result of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial	Laparascopy with coagulation excision of ovarian cysts and effect of ovarian reserve RESULT The result of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.	3 months after surgery

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: kareem labib, MD, Ain shams university maternity hospital

Publications and helpful links

General Publications

• Asgari Z, Rouholamin S, Hosseini R, Sepidarkish M, Hafizi L, Javaheri A. Comparing ovarian reserve after laparoscopic excision of endometriotic cysts and hemostasis achieved either by bipolar coagulation or suturing: a randomized clinical trial. Arch Gynecol Obstet. 2016 May;293(5):1015-22. doi: 10.1007/s00404-015-3918-4. Epub 2015 Oct 22.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): January 31, 2019

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pathological Conditions, Anatomical; Endometriosis; Ovarian Cysts; Cysts
• Other Study ID Numbers: Ain ShamsMH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No