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

Not Applicable

Completed

• Conditions: Sterilization, Tubal; Visual Analog Pain Scale
• Interventions: Procedure: tubal sterilization

• Registration Number: NCT04332120
• Lead Sponsor: Alanya Alaaddin Keykubat University

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

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-12-18
• Study Completion: 2020-01-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini Laparotomic	tubal sterilization	In patients undergoing spinal anesthesia, a suprapubic 3-5 centimeter incision was entered into the abdomen. After both tubes were isolated, bilateral tube ligation was performed by Pomeroy method. After bleeding control was achieved, it was repaired in accordance with the anatomy of the abdomen.
Laparoscopic	tubal sterilization	In patients undergoing general anesthesia, Verres was inserted into the abdomen through the umbilicus. Pneumo peritoneum was created with carbon dioxide (CO2). Optical imaging was placed into the abdomen from the umbilicus with 10-trochar. Auxiliary trochars from 3 centimeter supero-medial of both spina iliaca anterior superior were placed in the abdomen. bilateral tubas were isolated. Bilateral tubal ligation was performed with the help of bipolar cautery. bleeding control was achieved. trochars were taken out of the abdomen. the skin was closed.
posterior colpotomy	tubal sterilization	The patient underwent spinal anesthesia and was placed in a high lithotomy position. cervical uteri was observed with the help of speculum. A 3 centimeter vertical incision was opened 2 centimeter below the cervix uteri. Peritoneal cavity was entered from this area. bilateral tubas were isolated. Bilateral tubal ligation was performed using the pomeroy method. bleeding control was achieved. peritoneal and posterior cervical incision line was repaired.

Primary Outcome Measures

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