Clinical trial NCT04332120: Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization
Official title: Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sterilization, Tubal
Visual Analog Pain Scale
Keywords: colpotomy
sterilization
VAS
contraception
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 194
Sex: FEMALE
Minimum age (years): 32
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Pain Scale (VAS)
timeFrame: postoperative 6th hour
measure: Visual Analog Pain Scale (VAS)
timeFrame: postoperative 24th hour
measure: the amount of bleeding
timeFrame: 24 hour
measure: length of hospital stay
timeFrame: 48 hour
measure: duration of surgery
timeFrame: minimum duration of surgery 15 minute, maximum duration of surgery 60 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AKU
name: serhat yıldız
role: STUDY_DIRECTOR
References:
citation: American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 208: Benefits and Risks of Sterilization. Obstet Gynecol. 2019 Mar;133(3):e194-e207. doi: 10.1097/AOG.0000000000003111.
citation: Schlaeder G, Boudier E. [Tubal sterilization]. Rev Prat. 2002 Oct 15;52(16):1790-4. French.
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.
citation: Harkki-Siren P, Sjoberg J, Kurki T. Major complications of laparoscopy: a follow-up Finnish study. Obstet Gynecol. 1999 Jul;94(1):94-8.