Sterilization, TubalNCT04332120
Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization
A study testing tubal sterilization in people with Sterilization, Tubal and Visual Analog Pain Scale, run by Alanya Alaaddin Keykubat University.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 years and older, women only
- Conditions the study is for
- Sterilization, Tubal, Visual Analog Pain Scale
- What is being tested?
- tubal sterilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 31 years old
- Have completed the fertility request
- Accepting informed consent
Who cannot join
- Being under the age of 32
- Having a child desire
About this study
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.
Read the 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:
- Mini Laparotomic tubal ligation
- Laparoscopic tubal ligation
- 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
- Parity
- How many of their previous births are vaginal delivery, how many are cesarian section
- 6th hour Visual Analog Pain Scale (VAS) score
- 24th hour Visual Analog Pain Scale (VAS) score
- Preoperative - postoperative hmg differences
- Surgery time
- Length of hospital stay
- Conditions
- Sterilization, Tubal, Visual Analog Pain Scale
- Being tested
- tubal sterilization
- Keywords
- colpotomy, sterilization, VAS, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tubal sterilizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: tubal sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale (VAS)
postoperative pain degree. 0-10 point. 0 worst, 10 best
Measured: postoperative 6th hour
Visual Analog Pain Scale (VAS)
postoperative pain degree. 0-10 point. 0 worst, 10 best
Measured: postoperative 24th hour
the amount of bleeding
preoperative and postoperative hemogram differences
Measured: 24 hour
length of hospital stay
postoperative hospitalization
Measured: 48 hour
duration of surgery
The time from the administration of anesthesia to the end of the operation
Measured: minimum duration of surgery 15 minute, maximum duration of surgery 60 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jan 2016
- Primary completion18 Dec 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sterilization, TubalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammet serhat yıldız, Alanya Alaaddin Keykubat University
- Investigators
- serhat yıldız, Study director, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332120
- Sponsor's protocol ID
- 82752631
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30640233Schlaeder G, Boudier E. [Tubal sterilization]. Rev Prat. 2002 Oct 15;52(16):1790-4. French.
PubMed 12564171Chang 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.
PubMed 20339859Harkki-Siren P, Sjoberg J, Kurki T. Major complications of laparoscopy: a follow-up Finnish study. Obstet Gynecol. 1999 Jul;94(1):94-8.
PubMed 10389725
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Results of Different Surgical Techniques Used in Female Tubal Sterilization
- ClinicalTrials.gov ID
- NCT04332120
- Acronym / sponsor ID
- 82752631
- Conditions
- Sterilization, Tubal, Visual Analog Pain Scale
- Keywords
- colpotomy, sterilization, VAS, contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Mini Laparotomic tubal ligation
- Laparoscopic tubal ligation
- 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
- Parity
- How many of their previous births are vaginal delivery, how many are cesarian section
- 6th hour Visual Analog Pain Scale (VAS) score
- 24th hour Visual Analog Pain Scale (VAS) score
- Preoperative - postoperative hmg differences
- Surgery time
- Length of hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mini Laparotomic | Active comparator | Procedure: tubal sterilizationIn 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 | Active comparator | Procedure: tubal sterilizationIn 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 | Active comparator | Procedure: tubal sterilizationThe 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. |
Who may qualify
- Ages
- 32 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 31 years old
- Have completed the fertility request
- Accepting informed consent
Key exclusion criteria (2 listed)
- Being under the age of 32
- Having a child desire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tubal sterilization | Procedure or surgery | Laparoscopic, Mini Laparotomic, posterior colpotomy |
Primary outcome
Visual Analog Pain Scale (VAS)
Time frame: postoperative 6th hour
postoperative pain degree. 0-10 point. 0 worst, 10 best
Visual Analog Pain Scale (VAS)
Time frame: postoperative 24th hour
postoperative pain degree. 0-10 point. 0 worst, 10 best
the amount of bleeding
Time frame: 24 hour
preoperative and postoperative hemogram differences
length of hospital stay
Time frame: 48 hour
postoperative hospitalization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 30640233American 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.
- Background: PubMed 12564171Schlaeder G, Boudier E. [Tubal sterilization]. Rev Prat. 2002 Oct 15;52(16):1790-4. French.
- Background: PubMed 20339859Chang 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.
- Background: PubMed 10389725Harkki-Siren P, Sjoberg J, Kurki T. Major complications of laparoscopy: a follow-up Finnish study. Obstet Gynecol. 1999 Jul;94(1):94-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
serhat yıldız study director
AKU
Questions about this trial
What is this clinical trial studying?
A study testing tubal sterilization in people with Sterilization, Tubal and Visual Analog Pain Scale, run by Alanya Alaaddin Keykubat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scale (VAS) (time frame: postoperative 6th hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332120, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.