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

April 1, 2020 updated by: muhammet serhat yıldız, Alanya Alaaddin Keykubat University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: tubal sterilization
Active Comparator: 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.
Procedure: tubal sterilization
Active Comparator: 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.
Procedure: tubal sterilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Pain Scale (VAS)
Time Frame: postoperative 6th hour
postoperative pain degree. 0-10 point. 0 worst, 10 best
postoperative 6th hour
Visual Analog Pain Scale (VAS)
Time Frame: postoperative 24th hour
postoperative pain degree. 0-10 point. 0 worst, 10 best
postoperative 24th hour
the amount of bleeding
Time Frame: 24 hour
preoperative and postoperative hemogram differences
24 hour
length of hospital stay
Time Frame: 48 hour
postoperative hospitalization
48 hour
duration of surgery
Time Frame: 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
minimum duration of surgery 15 minute, maximum duration of surgery 60 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alanya Alaaddin Keykubat University

Investigators

  • Study Director: serhat yıldız, AKU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 82752631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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