Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization

Sterilization, Tubal Clinical Trial

Official title:

Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332120
• Other study ID #: 82752631
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2020
• Source: Alanya Alaaddin Keykubat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator's aim in this study is to compare the results of tubal ligation surgery, one of the contraceptive methods, between different surgical techniques. 194 patients were included in the study. Of these patients, 104 had vaginal approach, 44 had laparotomic and 46 had laparoscopic tube ligation surgery. These surgical techniques are statistically was compared; Visual Analog Pain Scale (VAS) after surgery, in terms of duration of surgery, length of hospital stay, cost to hospital and amount of blood loss. As a result of the analysis; tubal sterilization technique performed with vaginal colpotomy were found to be more successful than other techniques; Visual Analog Pain Scale score, postoperative hospital stay, operation time and cost.

Description:

The study compared the peroperative effects and postoperative results of different surgical techniques with three different techniques in patients undergoing tubal sterilization.

surgical techniques used:

1. Mini Laparotomic tubal ligation

2. Laparoscopic tubal ligation

3. tubal ligation by posterior colpotomy

A total of 194 patients were included in the study. Tubal ligation was performed in 44 patients with mini laparotomy, 46 patients with laparoscopy and 104 patients with posterior colpotomy technique.

The following parameters were evaluated in the study

1. Parity

2. How many of their previous births are vaginal delivery, how many are cesarian section

3. 6th hour Visual Analog Pain Scale (VAS) score

4. 24th hour Visual Analog Pain Scale (VAS) score

5. Preoperative - postoperative hmg differences

6. Surgery time

7. Length of hospital stay

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: January 1, 2020
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 32 Years and older

Eligibility

Inclusion Criteria:

• Over 31 years old

• Have completed the fertility request

• Accepting informed consent

Exclusion Criteria:

• Being under the age of 32

• Having a child desire

Related Conditions & MeSH terms

• Sterilization, Tubal
• Visual Analog Pain Scale

Intervention

Procedure:
• tubal sterilization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alanya Alaaddin Keykubat University

References & Publications (4)

ACOG Practice Bulletin No. 208: Benefits and Risks of Sterilization. Obstet Gynecol. 2019 Mar;133(3):e194-e207. doi: 10.1097/AOG.0000000000003111. — View Citation

Chang WH, Liu JY, Yeh YC, Wu GJ, Chiang YJ, Yu MH, Chen CH. Tubal ligation via colpotomy or laparoscopy: a retrospective comparative study. Arch Gynecol Obstet. 2011 Apr;283(4):805-8. doi: 10.1007/s00404-010-1435-z. Epub 2010 Mar 26. — View Citation

Härkki-Siren P, Sjöberg J, Kurki T. Major complications of laparoscopy: a follow-up Finnish study. Obstet Gynecol. 1999 Jul;94(1):94-8. — View Citation

Schlaeder G, Boudier E. [Tubal sterilization]. Rev Prat. 2002 Oct 15;52(16):1790-4. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale (VAS)	postoperative pain degree. 0-10 point. 0 worst, 10 best	postoperative 6th hour
Primary	Visual Analog Pain Scale (VAS)	postoperative pain degree. 0-10 point. 0 worst, 10 best	postoperative 24th hour
Primary	the amount of bleeding	preoperative and postoperative hemogram differences	24 hour
Primary	length of hospital stay	postoperative hospitalization	48 hour
Primary	duration of surgery	The time from the administration of anesthesia to the end of the operation	minimum duration of surgery 15 minute, maximum duration of surgery 60 minute