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

NCT ID: NCT04332120

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-01-01

Brief Summary

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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

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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

Conditions

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Sterilization, Tubal Visual Analog Pain Scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mini Laparotomic

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.

Group Type ACTIVE_COMPARATOR

tubal sterilization

Intervention Type PROCEDURE

Laparoscopic

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.

Group Type ACTIVE_COMPARATOR

tubal sterilization

Intervention Type PROCEDURE

posterior colpotomy

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.

Group Type ACTIVE_COMPARATOR

tubal sterilization

Intervention Type PROCEDURE

Interventions

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tubal sterilization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alanya Alaaddin Keykubat University

OTHER

Sponsor Role lead

Responsible Party

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muhammet serhat yıldız

Gynecologist and Obstetrician, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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serhat yıldız

Role: STUDY_DIRECTOR

AKU

References

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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.

Reference Type BACKGROUND
PMID: 30640233 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12564171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20339859 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10389725 (View on PubMed)

Other Identifiers

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82752631

Identifier Type: -

Identifier Source: org_study_id

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