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

NCT04332120 | Completed

• 1 other identifier: 82752631
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sterilization, Tubal; Visual Analog Pain Scale

Keywords

colpotomy; sterilization; VAS; contraception

Outcome Measures

Primary Outcomes (5)

• Visual Analog Pain Scale (VAS)

  postoperative pain degree. 0-10 point. 0 worst, 10 best

  postoperative 6th hour

• Visual Analog Pain Scale (VAS)

  postoperative pain degree. 0-10 point. 0 worst, 10 best

  postoperative 24th hour

• the amount of bleeding

  preoperative and postoperative hemogram differences

  24 hour

• length of hospital stay

  postoperative hospitalization

  48 hour

• 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

Study Arms (3)

Mini Laparotomic

ACTIVE COMPARATOR

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

Laparoscopic

ACTIVE COMPARATOR

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

posterior colpotomy

ACTIVE COMPARATOR

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

Interventions

tubal sterilization PROCEDURE

Laparoscopic; Mini Laparotomic; posterior colpotomy

Eligibility Criteria

• Age: 32 Years+
• Gender Eligibility Details: an operation for female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 31 years old
• Have completed the fertility request
• Accepting informed consent

You may not qualify if:

• Being under the age of 32
• Having a child desire

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Related Publications (4)

• 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.

  PMID: 30640233 BACKGROUND

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

  PMID: 12564171 BACKGROUND

• 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.

  PMID: 20339859 BACKGROUND

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

  PMID: 10389725 BACKGROUND

MeSH Terms

Interventions

Sterilization, Tubal

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Sterilization, Reproductive

Study Officials

• serhat yıldız

  AKU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist and Obstetrician, Principal Investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: January 1, 2016
• Primary Completion: December 18, 2018
• Study Completion: January 1, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-03